New test could potentially be offered at less than $150 enabling high compliance and global adoption
SUNNYVALE, Calif., Jan. 17, 2018 /PRNewswire/ — CellMax Life, a leading cancer diagnostics company enabling early cancer detection and management with globally affordable non-invasive blood tests, today announced results from a new study showing that its circulating tumor cell (CTC) blood test, based on its proprietary CMxTM platform, can detect colorectal cancer at an early stage – and in many cases, pre-cancerous lesions – with accuracy ranging from 84 to 88 percent.
Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second leading cancer killer in the United States. Traditional methods like colonoscopies and stool-based tests are invasive or inconvenient. For these reasons, compliance with colorectal cancer screening remains low, leading to most colorectal cancers being detected in late stages, when survival rates are poor.
“The positive results of this study prove that the CellMax CTC blood test can address the unmet need for a convenient and accurate test for early colorectal cancer detection; since the test only requires a routine blood draw, it can be easily integrated into a patient’s regular physical exam, increasing compliance,” said study co-author Ashish Nimgaonkar, MD, a gastroenterologist and medical director at the Center for Bioengineering Innovation & Design at Johns Hopkins University. “Additionally, research conducted by the American Cancer Society and Centers for Disease Control and Prevention states that test affordability is the number one reason patients cite for not undergoing regular screening for colorectal cancer. This blood test could potentially be offered between $100 and $150.”
CTCs are cancer cells that detach from a primary tumor and circulate through the bloodstream and are a fundamental mechanism of metastasis. CTCs have long been known to be valuable in cancer detection, but most technologies using CTCs are only able to detect late-stage cancer. The CellMax CTC blood test “liquid biopsy” detects these CTCs in the blood at the earliest stages. This is one of the first clinical studies to show that CTCs can be useful for detecting early, more treatable stages of cancer.
The researchers enrolled 620 people over the age of 20 who were either visiting the hospital for routine colonoscopies or had confirmed colorectal cancer. After a colonoscopy and biopsy, 438 people were found to have either adenomatous polyps (pre-cancerous growths) or early to late-stage colorectal cancer. The remaining study participants had no signs of pre-cancerous growths or colorectal cancer and were the comparison group.
Two milliliters (about half a teaspoon) of peripheral whole blood were tested from each subject for CTC analysis through a routine blood draw. The blood samples were then processed through the CMx platform. The results of these assays were then compared in a blinded analysis with the colonoscopy results.
The study results showed that the test’s sensitivity ranged from 77 percent for detection of CTCs in pre-cancerous lesions to 87 percent for stage I-IV cancers. The accuracy of the results, taking into account both sensitivity and specificity, was high and ranged from 84 to 88 percent for pre-cancerous and cancerous samples. Additionally, the accuracy of this test was superior to that of fecal occult blood testing (FOBT), a guideline-recommended stool test for colorectal cancer screening.
“Early detection is perhaps the only real cure for cancer. To be effective, tests for early cancer detection need to be non-invasive, easy, highly affordable and accurate, and our CTC blood test meets all of these requirements,” said Atul Sharan, co-founder and CEO of CellMax Life. “Recent surveys reveal a preference for blood tests over stool-based screening tests in more than 80 percent of patients who did not undergo invasive colonoscopy screening. This test can be an option for these individuals and boost compliance.”
The authors are planning more studies in Taiwan and will be extending the studies to the United States. The fundamental mechanism of circulating tumor cell shedding, and the capture using the CMx platform, are the same across all solid tumors. Thus, this platform is expected to provide favorable results for other solid tumors such as breast, lung and prostate cancers.
The data from the study, sponsored by Taiwan’s Ministry of Health and its largest hospital, the Chang Gung Memorial Hospital, will be presented by lead author, Dr. Wen-Sy Tsai (MD, Ph.D.) at the 2018 ASCO Gastrointestinal Cancers Symposium on Saturday, January 20. Attendees can also visit CellMax Life at booth #27 at the conference to learn more about the CellMax CTC blood test for colorectal cancer and the study’s results.
About CellMax Life
CellMax Life is a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management. CellMax Life’s unique expertise in circulating tumor cells (CTC) and next generation sequencing (NGS) of DNA, as well as circulating tumor DNA (ctDNA) has enabled it to offer highly effective precision medicine solutions for healthy people, as well as patients diagnosed with cancer.
CellMax Life’s tests include CellMax-DNA Hereditary Cancer Risk Test, CellMax-CRC Colorectal Cancer Screening Test, CellMax-Prostate Cancer Test, CellMax-LBx Liquid Biopsy for immunotherapy and targeted therapy selection and CellMax-PanCa Monitoring Test. All clinical testing is performed at CLIA and CAP accredited laboratories in Sunnyvale, California and Taipei, Taiwan.
For additional information, please visit www.cellmaxlife.com.
Antenna Group
Nathan Molinari (Media Contact)
CellMaxLife@antennagroup.com
201-465-8047
CellMax Life’s Precision, Non-Invasive Cancer Testing Now Available throughout Southeast Asia through Asia Genomics
CellMax and Asia Genomics Enter Broad Partnership to Serve Southeast Asia
Singapore and Sunnyvale, CA, July 11, 2017 — Asia Genomics, Southeast Asia’s leading clinical laboratory is partnering with Silicon Valley-based CellMax Life to immediately introduce CellMax Life’s multi-biomarker precision oncology blood and saliva tests across Southeast Asia. The advanced diagnostic testing will reduce cancer mortality through personalized, precision cancer risk assessment and screening in the Philippines, Vietnam, Malaysia, Thailand, and Singapore.
Affordable Precision Testing Gives Individuals Achieve More Control
According to the GLOBOCAN database, the ratio of cancer deaths to the number of new cancer cases in Asia was 0.66, twice that of North America (0.33). Only in Africa were cancer patients more likely to die (0.73). This an indication that cancer is not diagnosed until later stages in Asia, when it becomes difficult to treat effectively.
Individuals and their families no longer need to be passive about their health in the face of these risks — the Asia Genomics and CellMax Life partnership will give everyone more control over their health. Asia Genomics will immediately make available CellMax Life’s affordable personalized and precision cancer risk assessment and screening through various hospitals and clinics throughout Southeast Asia, and, where appropriate, direct to consumer.
Individuals can now achieve the earliest possible cancer detection and treatment by assessing their risk of cancer and doing more frequent screening through the non-invasive blood tests, so that they can undertake timely measures if cancer is diagnosed. In a complementary manner, Oncologists using the non-invasive blood tests will be able to more accurately assess the risk of cancer relapse, and offer personalized treatments to patients.
Next Generation Techniques Deliver Affordable, Precision Cancer Testing
The CellMax tests uniquely combine proprietary and clinically proven technologies that have been tested in Asia:
1. CellMax-DNA Genetic Cancer Risk Test — a simple saliva DNA test to identify hereditary cancer risk. The test provides an affordable and accessible saliva test to identify an individual’s cancer pre-disposition, to help them preempt worst case scenarios. It examines 98 genes across 25 hereditary cancers — currently the broadest gene panel on the market — offering highest quality, fastest turnaround time and affordable price. The largest possible number of individuals and families can for the first time better understand their risk of cancer, and then work with their doctors for a customized screening and lifestyle plan.
Hereditary gene mutations can increase the risk of cancer by 20 times. The test surveys for increased risk of some of the most common cancers in Southeast Asia: lung, liver, colorectal, prostate and stomach, along with bladder, lip, pancreas, breast, ovary and others.
2. CellMax-CRC Test — a non-invasive Circulating Tumor Cell (CTC) blood test that provides an early warning for Colorectal cancer.
Frequent screening to detect cancer early is the best prevention against the worst outcomes of the disease.
This non-invasive test, can be expected to dramatically increase compliance with recommended screening levels, and allow people to tailor the testing frequency to suit their risk.
Additionally, Asia-Genomics’ wide network of providers, leading oncologists, and support teams enable this precision cancer testing and support to be broadly accessible to every individual in South-East Asia.
“A major goal of Asia Genomics is to reduce cancer mortality in Southeast Asia, by offering convenient and affordable testing” said Dr. Wong Mun Yew, Founder & CEO, Asia Genomics. “Accuracy remains critical, and CellMax Life has made tremendous advances in precision analysis of key biomarkers, including CTCs which are pre-cursors to ctDNA.”
“CellMax Life is bringing early, non-invasive DNA and CTC-based cancer detection and management via affordable, accessible, accurate cancer saliva and blood tests,” said Atul Sharan, President and CEO. “Asia Genomics is unique in Asia – it has an unparalleled reputation, and strong relationships in the medical community across multiple countries. Their priority on making next generation cancer diagnostics, that works for Asians, highly accessible makes them an ideal fit with our vision.”
About Asia Genomics
Asia Genomics is a leading molecular diagnostics company focused on molecular biology and genomics to transform the healthcare industry in Asia. The Company offers tests that are evidence-based, accepted and endorsed by doctors internationally. Based in Singapore, with operations in Malaysia, Philippines, Vietnam, Indonesia, China, Hong Kong and Thailand, Asia Genomics has two laboratories, and a total market reach of more than 1.5 billion people. www.asia-genomics.com
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for affordable and accessible genetic cancer risk assessment, early detection, recurrence and personalized treatment of cancer. CellMax Life’s products include CellMax-DNA Genetic Cancer Risk Test Assure, CellMax-OncoLBx Liquid Biopsy, and CellMax-CRC Colorectal Cancer Early-Detection. www.cellmaxlife.com
CellMax Life Receives Grant from Taiwan Government for CTC Cancer Early Detection System
Non-Invasive Cancer Screening Investment Furthers CellMax’s Precision Oncology Testing Leadership
Sunnyvale, CA – June 14, 2017 – CellMax Life, the precision cancer testing company, today announced it has received a $NT 23 million grant from the Taiwan Government Industrial Development Bureau (IDB) Ministry of Economic Affairs. CellMax Life will use the grant to accelerate the automation and world-wide commercialization of its proven early cancer detection circulating tumor cell (CTC) proprietary CellMax CMxTM platform.
The prestigious IDB grant is awarded to a few selected companies, following an extensive application and review process involving experts from industry and academia. The grant is a key tool in the Taiwan government’s plan to accelerate development of high value-added technology.
“This is additional recognition that our CTC Technology is enabling early cancer detection in the high-growth cancer diagnostics area,” said Atul Sharan, president & CEO of CellMax Life. “We are thankful to the IDB for their proactive investment, which will help CellMax become a world leader in this important sector.”
Sharan continued, “These funds will allow CellMax Life to more rapidly expand availability of its CTC CMxTM platform throughout the world, enabling affordable and frequent screening to reduce cancer mortality.”
CellMax CRC Screening for Early Cancer Detection
CellMax Life provides clinically-proven early cancer detection using next generation technology to detect circulating tumor cell biomarker in the blood. CTCs enable the earliest possible cancer detection, as they are precursors to circulating tumor cell DNA (ctDNA) biomarkers.
CellMax CMx platform has been clinically proven on thousands of patients, and is initially being applied to the CellMax-CRC Colorectal Cancer early detection product, with a goal to improving CRC screening compliance for the high-risk population and those over age 50.
For high-risk patients, the clinical studies showed that approximately 90% of the time, the CMx Platform correctly identified the patients who had colorectal cancer.
Additionally, by offering an affordable, high accuracy, non-invasive blood test as an early warning system, CellMax hopes to tangibly increase the early-stage detection when cancer is most curable. The same technology will be applied to other cancers as development continues. For more information, please visit CellMax-CRC colorectal cancer screening.
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s products include CellMax-DNA Genetic Cancer Risk Test, CellMax-LBx Liquid Biopsy, and CellMax-CRC Colorectal Cancer Screening. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
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CellMax Life’s Personalized Precision, Non-Invasive Cancer Testing Now Available throughout India through CORE Diagnostics
New Delhi, India and Sunnyvale, CA — April 12, 2017: CORE Diagnostics, India’s leading clinical laboratory is partnering with Silicon Valley-based CellMax Life to immediately introduce CellMax Life’s genetic cancer risk test and ctDNA-based liquid biopsy throughout India. The two diagnostic advancements hold immense promise to reduce India’s cancer mortality by offering personalized, precision cancer risk assessment and screening.
The rate of survival of cancer victims remains dismal in India. According to estimates, less than 30 percent of people diagnosed with cancer in India survive for more than five years after their diagnosis—an indication that cancer is not diagnosed until later stages, when it becomes difficult to treat them effectively.
The goal of the partnership between CORE Diagnostics and CellMax Life is to empower individuals with personalized and precision cancer risk assessment and screening to enable the earliest possible cancer detection and treatment.
Accurately assessing the risk of cancer relapse allows Oncologists to offer better customized treatments to patients, rather than adopt a one-size fits all approach. On the other hand, assessing the risk of cancer allows patients to undertake timely preventive measures.
Accessible, Affordable Precision Cancer Testing Urgently Addresses India’s Low Cancer Survival Rate
The partnership achieves this from multiple angles:
1. CellMax-DNA Genetic Cancer Risk Test: a simple saliva DNA test to identify hereditary cancer risk.
- It provides an affordable and accessible saliva test to identify an individual’s cancer pre-disposition, to help them preempt worst case scenarios.
- The test examines 98 genes across 25 hereditary cancers — currently the broadest gene panel on the market, while priced to be affordable to the largest possible number of families.
- Individuals can now better understand their and their family’s risk of cancer, and then work with their doctors for a customized screening and lifestyle plan.
2. CellMax-LBx Liquid Biopsy: A non-invasive ctDNA blood test to improve cancer treatment management, monitor treatment response, and screen for recurrence – in real time.
- The test can also be used to detect risk of cancer recurrence.
- Due to its non-invasive nature, the liquid biopsy is more comfortable for patients, and can be less expensive, than surgically-obtained tissue biopsies. Thus, oncologists can more easily obtain actionable, real-time pictures of their patients’ cancer mutations during treatment.
- This test analyzes a comprehensive profile of 73 genes from circulating tumor DNA (ctDNA). Circulating tumor DNA are small DNA fragments shed by the tumor. Tumor genes may mutate over time, either as the cancer grows, or the treatment suppresses the cancer.
3. CORE Diagnostics’ wide network of providers, oncologists, and support teams enable this precision cancer testing and support to be broadly accessible to every individual in India.
The CellMax-DNA Genetic Cancer Risk Test, and CellMax LBx Liquid Biopsy products will be sold by Core as geneCORE Predict and liquiCORE Protect, respectively.
“At CORE Diagnostics, one of our major goals is to improve the process of cancer diagnosis in India by introducing convenient, more accurate and predictive tests that allow oncologists to provide more personalized treatments. For example, if a test is able to suggest accurately that the risk of cancer relapse is low in a patient, he/she can avoid more rigorous treatments. However, precision and accuracy remains the key. CellMax Life has made tremendous advances in precision analysis of key oncology biomarkers for cancer risk assessment and screening. This enables CORE to make these compelling personalized cancer tests available across India,” said Zoya Brar, Founder & MD, CORE Diagnostics.
“CellMax Life is bringing early, non-invasive DNA cancer detection via affordable, accessible, accurate cancer saliva and blood tests,” said Atul Sharan, President and CEO. “CORE Diagnostics is unique in India because of its clear priority toward making next generation diagnostics accessible throughout the country, through its high-quality medical infrastructure and bold innovation”.
About CORE Diagnostics
CORE Diagnostics is a clinical laboratory focused on next generation diagnostics for disease stratification and therapy selection. The company focuses on bringing the most advanced testing techniques and expertise to India and is the destination for all of India’s high-end diagnostic needs. CORE Diagnostics is truly one of a kind, because of: A rich menu of high-end tests; second opinion on every test from a global panel of pathologists; and very short turnaround time. The company’s initial test offerings have been in the areas of cardiology, oncology, reproductive disorders, endocrinology, and infectious diseases. For more information, please visit www.corediagnostics.in.
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for affordable and accessible genetic cancer risk assessment, early detection, recurrence and personalized treatment of cancer. CellMax Life’s products include CellMax-DNA Genetic Cancer Risk Test, CellMax-LBx Liquid Biopsy, and CellMax-CRC Colorectal Cancer Screening. For more information, please visit www.cellmaxlife.com.
INDIA: CellMax Life takes Liquid Biopsy to Next Level with 73 Gene Profile ctDNA Blood Test
CellMax-LBx Liquid Biopsy Assists with Tumor Treatment Response & Recurrence Monitoring
Sunnyvale, CA, January 4, 2017 – CellMax Life, the precision cancer testing company, announced today the commercial availability of CellMax-LBx Liquid Biopsy in India. CellMax-LBx is a cancer blood test which analyzes circulating tumor DNA (ctDNA). The assay provides oncologists with a valuable tool in managing their patients’ cancer treatments, monitoring treatment response, and assessing the risk of recurrence.
The non-invasive blood test allows for greater testing frequency for “real-time” monitoring. CellMax-LBx is intended as a supplement to a tissue biopsy, and as an ideal alternative when tissue biopsy is not possible. The test profiles 73 genes from circulating tumor DNA (ctDNA), to identify and assess actionable genomic alterations using CellMax Life’s proprietary single-molecule-sequencing SMSEQ™ platform, which has a greater than 99.999% specificity and an analytical detection limit of 0.1% (sensitivity).
Liquid Biopsies allow Real-time Tumor Monitoring and Optimized Treatment
There is growing evidence and medical acceptance that tumor signatures in a cancer patient’s blood – and their changes over time — can offer valuable, systemic insight into therapy selection, cancer treatment monitoring and recurrence.
Non-invasive “liquid biopsies” such as blood tests are growing in use as they help overcome problems of inherent tumor heterogeneity of cancer cells, while providing previously unavailable insight into drug-resistance. They are key in tracking and monitoring an otherwise intractable disease.
Due to their non-invasive nature, liquid biopsies can be less expensive than surgically-obtained tissue biopsies. Liquid biopsies are more comfortable for patients, which is especially important given the stress that cancer and associated treatments already place on patients.
Circulating tumor DNA are small DNA fragments shed by the tumor. Tumor genes may mutate over time, either as the cancer grows, or the treatment suppresses the cancer. ctDNA gives an accurate, real-time picture of these cancer mutations.
Being able to detect the smallest signals and trends from the ctDNA biomarker throughout the cancer management process offers timely insight and may yield information into the most effective treatment regimens tailored to the patient’s specific cancer genomic profile.
“CellMax-LBx Liquid Biopsy will be a major factor in cancer treatment; the specificity of the assay is greater than 99.999% due to CellMax’s innovative SMSEQ platform,” stated Dr. Ruey-Kuen Hsieh, MD, Oncologist, Superior Commissioner, Superintendent’s Office, Sr. Attending Physician, and former Cancer Center Chair, MacKay Memorial Hospital. “CellMax-LBx Liquid Biopsy provides a systemic gene analysis to help oncologists identify optimal targeted cancer treatments with fewer side-effects, either as a supplement to tissue biopsy, or when tissue-biopsy is not possible. Additionally, since this test requires only a routine blood draw, it enables us to track our patients’ response to treatment in real-time, as well as monitor them more frequently to warn of cancer recurrence as early as possible.”
CellMax-LBx Liquid Biopsy enables Personalized Cancer Management
The CellMax-LBx Liquid Biopsy analyzes ctDNA biomarkers. Oncologists can use this information to:
- Monitor patient treatment response
CellMax Life currently offers a comprehensive ctDNA gene profile of 73 genes from circulating tumor DNA, allowing broad insight into the patient’s response to treatment by measuring the ctDNA trend throughout the course of cancer treatment. Over the treatment process, certain mutations of interest may decrease; additionally, cancer treatments can also create new mutations which should be monitored.
- Assess Recurrence Risk
Early study results published in Science Translational Medicine showed that the presence of ctDNA four-to-ten weeks post tumor removal could be used to predict cancer recurrence as early as stage II colon cancer. Similar clinically important findings have been seen with ctDNA for lung and breast cancer, according to the American Association for Cancer Research.
- Determine targeted, personalized treatments
By analyzing the genomic profile of a cancer tumor, it is often possible for doctors to personalize and optimize patient treatments based on known therapeutically targetable mutations. CellMax delivers the patient’s comprehensive genomic profile in a tailored summary report which matches each gene mutation with potentially relevant targeted therapies and clinical trials.
Due to its non-invasive nature, CellMax-LBx can be utilized on an “as needed” basis, allowing oncologists to do more real-time analysis.
“The incidence of cancer is expected to increase 70% over the next two decades. CellMax Life’s goal is to reduce cancer mortality by empowering patients and their doctors to make the most informed health decisions possible, with the necessary frequency,” stated Dr. Rui Mei, PhD, Chief Scientific Officer, CellMax Life. “By allowing oncologists to conveniently monitor the ctDNA and their changes over time, our tests can offer physicians valuable insights.”
Case Study: CellMax-LBx used to Tailor Lung Cancer Treatment for Adult Male
Adult male patient reported into the emergency room, and was diagnosed with stage-II lung cancer.
“CellMax-LBx liquid biopsies were conducted separately on a pleural effusion sample and a routine peripheral blood-sample — both revealed an actionable EGFR mutation. Additionally, both biopsies revealed a TP53 mutation for which the CellMax-LBx report identified a drug in Phase-3 trial,” said Li-Kuan Chen, MD, Chair, Department of Clinical Pathology, Hualien Tzu Chi Hospital. “As a Pathologist, I worked with the patient’s Oncologist to utilize this combined information to tailor the best treatment for the patient. We will continue to use CellMax-LBx to monitor the patient’s response and progress.”
Availability and Pricing
CellMax-LBx Liquid Biopsy, which utilizes the CellMax SMSEQ™ Platform to analyze ctDNA biomarkers is commercially available immediately in India for 200,000 INR.
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s products include CellMax-DNA Genetic Cancer Risk Test, CellMax-LBx Liquid Biopsy, and CellMax-CRC Colorectal Cancer Screening. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
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INDIA: CellMax Life Announces Genetic Cancer Risk Test for 98 Genes, 24 Hereditary Cancers
New Saliva Test offers broadest gene panel
Sunnyvale, CA, Nov 16, 2016 – CellMax Life, the precision cancer testing company, announced today the immediate availability in India of the CellMax-DNA Genetic Cancer Risk Test, which examines 98 genes across 24 hereditary cancers using its proprietary SMSEQ™ Platform. The CellMax-DNA Genetic Cancer Risk Test requires only a saliva sample.
CellMax Life’s DNA test uses next generation sequencing to detect gene mutations known to increase lifetime cancer risk. The test surveys for increased risk of 24 cancers including some of the most common cancers: breast, lip, lung, colorectal and stomach, along with prostate, bladder, thyroid, ovary and others.
As an example of the extensive breadth of the gene panel analyzed by CellMax Life, to assess breast cancer risk, the CellMax-DNA test covers BRCA1 and BRCA2 genes entirely, and also examines a number of other genes associated with breast cancer, including ATM, BARD1, CDH1, CHEK2, NBN, NF1, PALB2, PPM1D, PTEN, RAD51C, RAD51D, STK11, TP53.
Genetic Mutations Can Increase Cancer risk by 20 times
Genetic mutations associated with increased cancer risk are passed from parent to offspring. These inherited abnormal genes are in contrast to acquired mutations which occur after birth and over time, and include environmental factors and lifestyle choices such as smoking or sun exposure.
Individuals with certain inherited genetic mutations carry a higher lifetime risk for various cancers. Their risk of getting these cancers can be up to 20 times greater than individuals without these mutations. Cancers impacted by these inherited gene mutations are typically referred to as hereditary cancers.
“The public has already been fairly well-educated on the value of genetic testing for breast cancer,” said Dr. Ashish Nimgaonkar, MD, Asst. Professor of Medicine and Associate Medical Director, Center for Bioengineering Innovation and Design at Johns Hopkins University, USA. “The ability of the CellMax-DNA Genetic Cancer Risk Test to identify mutations associated with 24 hereditary cancers in an affordable saliva test, is valuable to both patients and their doctors in planning for appropriate screening frequency and preventative measures.”
“Early cancer detection is the most effective way to fight cancer,” said Dr. Tai Cheng-Jeng, MD, PhD, Chief, Division of Hematology & Oncology, Department of Internal Medicine, Taipei Medical University Hospital, Taiwan. “CellMax Life’s convenient genetic cancer saliva DNA test based on the next generation sequencing SMSEQ platform offers the broadest gene panel for known hereditary cancers, allowing doctors and their patients to collaborate on personalized, optimal health planning.”
Cancer Risk Identification Enables Personalized Screening for More Effective Medicine
According to the U.S. National Cancer Institute, more than 4 in 10 people in the United States will get cancer in their lifetime. Individuals who inherit mutated genes associated with cancer:
- Have a greater risk of getting cancer
- Tend to get their cancers earlier in life
- The cancer is usually more aggressive
Thus, individuals who know they have inherited an increased cancer risk can work with their doctors to plan for earlier and more frequent cancer screening.
It is well-accepted that the prognosis for cancer survival is higher when detected at early stages. The survival outlook is assessed by the 5-year survival rate stratified based on stage of detection. Some examples are shown below.
- Colorectal cancer: Stage one has more than 90% survival rate, while stage three and four detection survival is as low as 10%.
- Breast cancer: Stage one has almost a 100% survival rate. Stage four cancer has only 22%.
“Our goal is to make personalized, comprehensive cancer diagnostics affordable and accessible to every individual,” said Dr. Mana K Javey, MD, PhD, VP of Medical Affairs, CellMax Life. “By providing the industry’s broadest gene panel for hereditary cancer risk testing, we are enabling individuals and their physicians to do high-impact health planning.”
About the SMSEQ Platform and CellMax-DNA Genetic Cancer Test
The CellMax SMSEQ™ platform has an analytical specificity of ≥99.999%This patented technology, combined with years of research and development advancements enables CellMax to offer an extremely cost effective and comprehensive genetic cancer risk test, utilizing an expanded 98 gene panel using personal DNA from a saliva sample.
The CellMax-DNA Genetic Cancer Risk Test is available immediately via CellMax Life’s CLIA certified laboratory in Sunnyvale, CA. The test is priced at ₹30,000 INR, and can be ordered online or through CellMax Life’s provider network. No dietary restrictions or medication alterations are necessary.
For more information, please visit CellMax-DNA Genetic Cancer Risk Test.
Case Study: 32-year-old Learns of Hereditary Cancer Risk
Mr. Chen, 32-year-old resident of Kaohsiung, has a family history of cancer, which concerned him for many years. Mr. Chen took the CellMax-DNA Genetic Cancer Risk Test, and learned that he carried a genetic mutation associated with an increased risk of cancer.
“My family has a history of cancer, but no one had ever been tested for genetic cancer risk — so I had been worried for many years. When I learned I could find out whether I personally had an increased risk for hereditary cancers through a saliva test, I decided to take it,” said Mr. Chen.
He continued: “I found out that I do carry a genetic mutation related to increased risk of colorectal cancer. Knowing this I will begin screening earlier, and do it more frequently that I would have otherwise.”
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s products include CellMax-DNA Genetic Cancer Risk Test, and CellMax-CRC Colorectal Cancer Screening, a multi-biomarker blood test for early detection of colorectal cancer. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
CellMax Life Announces Genetic Cancer Risk Test for 98 Genes, 24 Hereditary Cancers
Saliva Test to cost only $149 through end of 2016, with broadest panel covering 98 genes
Sunnyvale, CA, Nov 16, 2016 – CellMax Life, the precision cancer testing company, announced today the immediate availability in the United States of the CellMax-DNA Genetic Cancer Risk Test, which examines 98 genes across 24 hereditary cancers using its proprietary SMSEQ™ Platform. The CellMax Genetic Cancer Test requires only a saliva sample, and will be sold to consumers for only $149 through the end of 2016.
CellMax Life’s DNA test uses next generation sequencing to detect gene mutations known to increase lifetime cancer risk. The test surveys for increased genetic risk of 24 cancers including some of the most common cancers: Lung, Breast, Colorectal, Prostate, Stomach, along with Bladder, Pancreas, Kidney, Thyroid, Ovary and others.
As an example of the extensive breadth of the gene panel analyzed by CellMax Life, to assess breast cancer risk, the CellMax-DNA test not only covers BRCA1 and BRCA2 genes entirely, but also examines a number of other genes associated with breast cancer including ATM, BARD1, CDH1, CHEK2, NBN, NF1, PALB2, PPM1D, PTEN, RAD51C, RAD51D, STK11, TP53.
Genetic Mutations Can Increase Cancer Risk by 20 times
Genetic mutations associated with increased cancer risk are passed from parent to offspring. These inherited abnormal genes are in contrast to acquired mutations which occur after birth and over time, and include environmental factors and lifestyle choices such as smoking or sun exposure.
Individuals with certain inherited genetic mutations carry a higher lifetime risk for various cancers. Their risk of getting these cancers can be up to 20 times greater than individuals without these mutations. Cancers impacted by these inherited gene mutations are typically referred to as hereditary cancers.
“The public has already been fairly well-educated on the value of genetic testing for breast cancer,” said Dr. Ashish Nimgaonkar, MD, Asst. Professor of Medicine and Associate Medical Director, Center for Bioengineering Innovation and Design at Johns Hopkins University, USA. “The ability of the CellMax-DNA Genetic Cancer Test to identify mutations associated with 24 hereditary cancers in an affordable saliva test, is valuable to both patients and their doctors in planning for appropriate screening frequency and preventative measures.”
Cancer Risk Identification Enables Personalized Screening for More Effective Medicine
According to the U.S. National Cancer Institute, more than 4 in 10 people in the United States will get cancer in their lifetime. Individuals who inherit mutated genes associated with cancer:
- Have a greater risk of getting cancer
- Tend to get their cancers earlier in life
- The cancer is usually more aggressive
Thus, individuals who know they have inherited an increased cancer risk can work with their doctors to plan for earlier and more frequent cancer screening.
It is well-accepted that the prognosis for cancer survival is higher when detected at early stages. The survival outlook is assessed by the 5-year survival rate stratified based on stage of detection. Some examples are shown below.
- Colorectal cancer: Stage one has more than 90% survival rate, while stage three and four detection survival is as low as 10%.
- Breast cancer: Stage one has almost a 100% survival rate. Stage four cancer has only 22%.
“Our goal is to make personalized, comprehensive cancer diagnostics affordable and accessible to every individual,” said Dr. Mana K Javey, MD, PhD, VP of Medical Affairs, CellMax Life. “By providing the industry’s broadest gene panel for hereditary cancer risk testing, we are enabling individuals and their physicians to do high-impact health planning.”
About the SMSEQ Platform and CellMax-DNA Genetic Cancer Test
CellMax Life’s SMSEQ™ platform has an analytical specificity of ≥99.999%This patented technology, combined with years of research and development advancements enables CellMax to offer an extremely cost effective and comprehensive genetic cancer risk test, utilizing an expanded 98 gene panel using personal DNA from a saliva sample.
The CellMax-DNA Genetic Cancer Risk Test is available immediately via CellMax Life’s CLIA certified laboratory in Sunnyvale, CA. The test will available for only $149 through December 31, 2016; it is normally priced at $299. The test can be ordered online or through CellMax Life’s provider network. No dietary restrictions or medication alterations are necessary. CellMax is currently available throughout the United States, except for selected states; new states are being added on a regular basis. CellMax Life’s current list of states.
For more information, please visit CellMax-DNA Genetic Cancer Risk Test.
Case Study: 32-year-old Learns of Hereditary Cancer Risk
Mr. Chen, 32-year-old resident of Kaohsiung, has a family history of cancer, which concerned him for many years. Mr. Chen took the CellMax-DNA Genetic Cancer Risk Test, and learned that he carried a genetic mutation associated with an increased risk of cancer.
“My family has a history of cancer, but no one had ever been tested for genetic cancer risk — so I had been worried for many years. When I learned I could find out whether I personally had an increased risk for hereditary cancers through a saliva test, I decided to take it,” said Mr. Chen.
He continued: “I found out that I do carry a genetic mutation related to increased risk of colorectal cancer. Knowing this I will begin screening earlier, and do it more frequently that I would have otherwise.”
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s products include CellMax-DNA Genetic Cancer Risk Test, and CellMax-CRC Colorectal Cancer Screening, a multi-biomarker blood test for early detection of colorectal cancer. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
CellMax Life Achieves CLIA Certification & CAP Accreditation for Precision Cancer Testing Laboratories
CLIA Certification in the U.S. and CAP Accreditation in Taiwan
Sunnyvale, CA and Taipei City, Taiwan, October 18, 2016 – CellMax Life announced today the company has received certification under the Clinical Laboratory Improvement Amendments (CLIA). The company also announced it has received notice of accreditation from the College of American Pathologists (CAP) for its Taipei laboratory.
CLIA regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. To gain the CLIA certification, CellMax had to meet quality standards for proficiency testing, management of patient testing, personnel qualifications, quality control, and quality assurance.
CAP accreditation is an internationally recognized standard of operational excellence. It is recognized by the United States government as being equally or more stringent than the federal inspection program, and is specifically designed to ensure the highest standard of care for all laboratory samples.
“We are committed to reducing cancer mortality by making affordable, non-invasive early cancer detection easily accessible globally to everyone,” said Atul Sharan, President and CEO of CellMax Life. “These clinical laboratories certifications, along with our breakthrough proprietary CTC CMx platform, pave the way for our next growth phase in the United States, and give us a unique springboard into China and India.”
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s flagship product is CellMax CRC-Protect, a multi-biomarker blood test based on their proprietary CTC CMx platform for early detection of colorectal cancer, which is currently marketed in Taiwan. CellMax Life has CLIA certification and CAP accreditation for its United States and Taiwan laboratories, respectively. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
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CellMax Life Raises $14M in Venture Funding, Launches Precision Cancer Testing Company for Early Detection & Optimal Management of Cancer
Personalized Cancer Blood Biomarker Technology Platform Shifts Cancer Treatment to more Manageable Early Stages
Sunnyvale, CA, July 26, 2016 – CellMax Life, Inc. today announced $9M in series A-1 venture funding, and formally introduced itself as a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms. The company will fundamentally transform cancer care away from expensive, intractable late-stages to early, more treatable stages.
With a comprehensive portfolio of blood tests based on its proprietary, clinically proven rare-cell and genomic technology platforms, CellMax Life’s mission is to dramatically reduce cancer mortality by making affordable risk-assessment, screening and targeted therapy selection easily accessible globally to everyone. The company’s next generation liquid biopsy includes both Circulating Tumor DNA and Circulating Tumor Cells, for optimal personalized cancer treatment with immediate high clinical impact.
$9M in Series A-1 Venture Funding, Brings Total Funding to $14M
The company also announced today that it has received $9 Million in series A-1 venture financing for scaling commercial operations of its unique cancer blood test product portfolio, bringing its total venture investment to date to $14 Million.
The $9M in funding was led by Silicon Valley venture capital firm Artiman and several Taiwanese venture investors who are committed to making a global impact, including Stan Shih, founder, and honorable chairman of Acer, Inc.
“After several years of research and clinical testing, CellMax Life has developed a range of technologies to detect multiple cancer biomarkers in blood,” stated Dr. Dave Lawrence, Advisor, Artiman Ventures, and former chairman & CEO of the world’s largest HMO, Kaiser Foundation Health Plan and Hospitals. “CellMax Life’s clinically-proven blood test portfolio is effective across the cancer care spectrum, and especially so for early cancer detection.”
Stan Shih stated, “Over half of the cancer deaths worldwide occur in Asia, and the number is increasing. This serious problem cannot be solved with traditional, expensive cancer drugs alone. We invested in CellMax Life because with their breakthrough proven early detection CMx platform, they are leading a paradigm shift in cancer detection that will address the cancer in Asia cost-effectively and at scale.”
The company was founded in 2012, developing new technology as well as utilizing technology under development since 2007. The new $9M in funding is being used for continued product development, ongoing clinical trials, and commercialization of the full range of blood tests, including genetic cancer risk detection, and early cancer detection for colorectal and other cancers.
Liquid Biopsy for Optimal Personalized Cancer Treatment
“We founded CellMax Life to transform how cancer is identified and managed in ways never before possible. Early detection is the best defense against this asymptomatic disease — when treatment costs are low and survival rates are high,” said Atul Sharan, co-founder and CEO. “With our accessible and accurate cancer blood tests, we are able to bring early, non-invasive cancer detection to the broadest population possible, enabling individuals to take control of their own health.”
In a separate announcement today, CellMax Life has announced its first product, CellMax CRC-Protect, a clinically proven, multi-biomarker blood test for early detection of colorectal cancer.
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s flagship product is CellMax CRC-Protect, a multi-biomarker blood test for early detection of colorectal cancer, which is currently marketed in Taiwan. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
CellMax Life Announces CellMax CRC-Protect, a Multi-Biomarker Blood Test Clinically-Proven For Early Detection of Colorectal Cancer
Double-blind clinical studies conducted
Sunnyvale, CA and Taipei City, Taiwan, July 26, 2016 – CellMax Life, the precision cancer testing company, announced today that CellMax CRC-Protect, its blood-based test for early detection of colorectal cancer based on the CMx Platform®, is now available in Taiwan.
The CellMax CRC-Protect blood test has been clinically proven for colorectal cancer detection in two separate studies of over 500 Taiwanese patients at leading medical centers in Taiwan, including Chang Gung Memorial Hospital (CGMH).
For moderate to high risk patients, the clinical studies showed that over 90% of the time the CMx Platform correctly identified the patients who had colorectal cancer.
The breakthrough test requires only blood sample, which can be drawn as part of a regular healthcare provider visit; no dietary restrictions or medication alterations are necessary.
Colorectal Cancer on Rise in Taiwan
Colorectal cancer is the most common form of cancer in Taiwan, with the rate continuing to rise unabated every year. According to the ROC Ministry of Health and Welfare, in 2013 there were more than 15,140 new diagnosed cases of colorectal cancer — one person is diagnosed every 35 min with colorectal cancer in Taiwan.
“Only 30 percent of patients in Taiwan over age 50 are being regularly screened according to medical guidelines,” said Dr. Mana K Javey, MD, PhD, VP of Medical Affairs, CellMax Life. “A simple CRC blood test can be useful as an early warning system, to the vast majority of patients who are non-compliant to other screening tests such as colonoscopies and stool tests.”
Late Stage Colorectal Cancer detection has higher costs & higher mortality rate.
Although screening and early detection of colorectal cancer have been conclusively shown to save lives, about 50 percent of colorectal cancer cases are not detected until stage 3 or 4, where the survival rate can drop to as low as 10%, compared to a survival rate of more than 90 percent for early stage cancer. The costs of treating late stage cancer can be as high as USD 200,000 per patient, prohibitive for most patients.
“CellMax CRC-Protect’s ability to detect colorectal cancer in early stages, with a convenient blood test, can be a valuable early warning system for the vast majority of those who are reluctant to take a stool test or colonoscopy for screening.” said Dr. Ashish Nimgaonkar, MD, Asst. Professor of Medicine (Gastroenterology) and Assoc. Medical Director, Center for Bioengineering Innovation and Design, Department of Biomedical Engineering at Johns Hopkins University, USA.
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Circulating Tumor Cells as Biomarker for early Cancer Detection
A major new development in cancer research over the past decade has been the role of circulating tumor cells (CTC). Circulating tumor cells are cells shed from the primary tumor site into the bloodstream, where they then may travel to other sites in the body to form metastatic lesions, or to be destroyed.
“Circulating tumor cells can serve as a clear indicator of the presence of cancer in the body, often earlier than other indicators or detection methods,” said Dr. Rui Mei, PhD, CSO of CellMax Life. “The technological challenge is to detect these extremely rare cells in the blood and to keep them viable for further analysis.”
The tremendous difficulty of identifying these rare circulating tumor cells can be understood by looking at the order of magnitude of their presence at different cancer stages:
- Pre-cancer has 1 CTC per billion blood cells
- Early stage cancer has 10 CTC’s per billion blood cells.
- Late stage cancer has 100s of CTCs per billion blood cells
“The most effective way to prevent colorectal cancer mortality is to detect it early,” said Dr. Tsai Wen-Shi, MD, PhD, of CGMH. “This non-invasive blood test based on the CMx platform, with high clinically demonstrated accuracy and high accessibility, has the potential to detect cancer at earlier stages.”
The CMx Platform detects circulating tumor cells in the blood, even at early cancer stages
The fundamental principle behind the recent breakthrough in early CRC detection relies on the ability to find extremely rare, abnormal cells in a sea of billions of normal cells in a blood sample. The CMx Platform™ can detect rare abnormal, potentially cancerous cells in the blood, just like a very vigilant radar. With this new technology, early‐stage colorectal cancer, and even pre‐cancer, can be detected.
Case Study: Early Detection via CMx Platform Blood Test Saves Life
Lily Liao, a resident of Taipei, has been vigilant about her health for many years.
Lily stated, “Despite having a family history of cancer, including my oldest brother passing away because of colorectal cancer, I was afraid of the side effects of anesthesia and of the risk for my colon to be injured during a colonoscopy so I avoided it. I heard the CellMax Life CMx platform test could detect abnormal colon cells in the very early stages of cancer from a simple blood draw, and decided to take it.”
When her test came back abnormal, Lily Liao went for a colonoscopy, which found several polyps in her colon, including some pre-cancerous polyps, which the doctor removed.
“If I’d never taken the CellMax CMx platform blood test, I would probably still believe I would not get colorectal cancer in the absence of symptoms. Now I am finally relieved, and take the CellMax Life test regularly to monitor my condition,” Lily concluded.
To view Lily’s video case study, please see CRC blood test patient case study.
About CellMax Protect and the CMx Platform
CellMax Life’s patented CMx Platform is clinically proven to detect early-stage circulating tumor cells (CTCs) that are shed from the primary tumor site into the bloodstream in early stage cancer. The CMx Platform uses a biomimetic, lipid-bilayer coated microfluidic chip to capture these rare cells in peripheral blood. The test can be useful in cases of non-compliance with recommended colonoscopies or messy stool tests, and as a supplemental screening.
For more information, please visit CellMax Protect early cancer screening blood test.
About CellMax Life
CellMax Life, Inc. is a precision cancer blood-testing company providing comprehensive, personalized multi-biomarker technology platforms for genetic cancer risk assessment, early detection and personalized treatment of cancer. CellMax Life’s flagship product is CellMax CRC-Protect, a multi-biomarker blood test for early detection of colorectal cancer, which is currently marketed in Taiwan. For more information, please visit www.cellmaxlife.com, tw.cellmaxlife.com, or call +1 650-564-3905 (U.S.), or (+886) 0800-555-885 (Taiwan). Offices are at: 1271 Oakmead Parkway, Sunnyvale, CA 94085 and 18F-1 Park Street, Nangkang, Taipei City.
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