MedTech Breakthrough Awards, 2018 — Leading Cancer Management Company Wins Prestigious Award for its Proprietary Circulating Tumor Cell (CTC) CMx Platform
CellMax Life, a leading cancer detection and management company with clinically proven, affordable and non-invasive early cancer detection blood tests, announced today that its proprietary CMx™ circulating tumor cell (CTC) platform has won the 2018 MedTech Breakthrough Award for Best New Technology Solution in Cancer Management. CellMax Life was chosen from over 3,000 nominations, placing it among the organization’s previous winners that include leading medical technology companies such as 23andMe, WebMD, Samsung, Stryker, Apple, IBM Watson, Humana and Zocdoc.
“We are honored to win this award and receive this respected recognition for our CMx platform,” said Atul Sharan, CEO of CellMax Life. “Our CMx platform gives patients and physicians the ease, accuracy and affordability that an early cancer detection test should have, and we are hopeful that adoption of this proven technology will substantially improve cancer survival rates in the country. Adoption of screening dramatically impacts mortality rates from cancer. The best example of this is probably cervical cancer, which was once one of the most common causes of cancer death for American women. However, since the onset of widespread PAP screening the cervical cancer death rate has dropped by 60%”
Colorectal cancer is among the most preventable cancers, with greater than 90% survival rates when detected early. Yet it is the second leading cancer killer in the United States. Screening tests such as colonoscopies and stool-based tests for colorectal cancer are either invasive or inconvenient and serve as a deterrent for routine screenings, with statistics demonstrating that one in three eligible Americans have never been screened for colorectal cancer. As a result, most colorectal cancer is diagnosed when the cancer is already advanced. Survival rates for colorectal cancer that has spread to other organs are only 14%. Blood tests may offer a solution. Published surveys suggest that patients who are reluctant to undergo colonoscopy screenings are very receptive to blood tests. In fact, over 83 percent of those surveyed preferred a blood test over a stool test.
Circulating tumor cells or CTCs are cells that shed from a tumor and circulate into the bloodstream very early in cancer development. However, they are very rare in early stage cancer, presenting in fewer than five cells in a background of one billion cells, and until now have been virtually impossible to detect with high accuracy. The globally affordable CellMax Life blood test aims to transform early cancer detection and management with a platform that isolates these rare CTCs with a single blood sample. The CMx platform provides an accessible and affordable alternative for the 85 million individuals who are eligible for routine cancer screenings.
The CMx platform has eight patents for its proprietary technology that contains a microfluidic chip with lipid coating mimicking the human epithelium, proprietary antibodies, gentle air-foam based cell release, and advanced imaging, capturing CTCs in up to 90 percent of early stage cancer patients across cancers such as colorectal, prostate and lung. A study announced by the American Society of Clinical Oncology (ASCO) showed that the accuracy of the test ranged from 84 to 88 percent for the detection of early stage colorectal cancer and pre-cancer. Additionally, the platform’s successful detection of prostate cancer could help reduce unnecessary invasive biopsies by up to 90 percent in patients receiving indeterminate results following a PSA screen by clarifying what patients need the procedure.
“An affordable test with keen sensitivity for early cancer detection like the CTC blood test has the potential to transform cancer diagnostics,” said Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis. “The potential applications can go well beyond early detection to guiding treatment selection for patients diagnosed with cancer. This CTC test can detect the expression of PD-L1 – a key protein involved in suppressing the immune system. Patients who express this protein have better response rates to immunotherapy treatment that those who do not express this protein.”
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 http://www.cellmaxlife.com.
About MedTech Breakthrough
The MedTech Breakthrough Awards program is devoted to honoring excellence in medical and health related technology companies, products and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough MedTech companies and products in categories including Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more. For more information visit http://www.MedTechBreakthrough.com.
Antenna Group
Michael Simmons (Media Contact)
CellMaxLife(at)antennagroup.com
201-465-8030
NEW YORK (360Dx) – CellMax Life announced this week that it is beginning a new clinical trial, which will further validate its circulating tumor cell (CTC) colorectal cancer screening test in American subjects, with the goal of supporting a submission for approval by the US Food and Drug Administration.
The study is being conducted with a handful of medical centers, including Stanford Medicine, the US Department of Veterans Affairs, Johns Hopkins, and the University of Southern California. CellMax’s CRC screening test is currently only available in Asia, where it has been offered for about two years, but the company has had plans in place for some time to bring the assay to the US market. CEO Atul Sharan said in an interview that the company expects to complete the analytical validation study, along with additional algorithm development work, by the end of this year.
While the company waits for this process to play out, Sharan said that it intends to launch a version of the assay before the end of this year as a laboratory-developed test through its CLIA lab.
“We have been seeing a lot of demand from labs, physicians, and patients following [our presentation this January],” he said.
CellMax has stated that its CMx platform, which involves what the company has described as a “chaotic mixing microfluidic chip,” isolates rare CTCs present at a fraction of 1 to 10 CTCs in a background of one billion normal cells. The current CRC screening application is based simply on the presence or absence of CTCs, although the platform does allow for follow-on genomic or other molecular analyses of captured cells.
This January, the company shared results at the 2018 ASCO Gastrointestinal Cancer Symposium from a prior validation study in Asian subjects, which found that its test could detect colorectal cancer at an early stage with accuracy ranging from 84 to 88 percent in a cohort of 600 individuals recruited at Taiwan’s Chang Gung Memorial Hospital. The new US trial would confirm that the test also works in a non-Asian population and is also positioned to answer some lingering questions that were not addressed in the previous study. For example, the new validation is being conducted in an intended-use population, whereas the Taiwan study cohort did not reflect a real-world screening population.
According to Sharan, the way subjects were recruited in the Taiwan trial resulted in a cohort that was weighted toward symptomatic patients. Despite this, he argued that clinicians at the ASCO GI meeting responded very positively to the results. Sharan said that the new US study will recruit between 3,000 and 5,000 individuals of either sex, who are 50 years or older and are coming in for routine colorectal cancer screening via currently available colonoscopy or stool tests.
Study participants who consent will be tested in parallel using CellMax Life’s blood test and whichever standard-ofcare screening they were already slated to receive. Researchers will then compare results of the blood test with the outcomes of subjects’ colonoscopy or stool analyses.
According to Sharan, CellMax is working with the FDA to define the details of the study and to make sure that it is designed in a way that the appropriate data can be collected to submit the test for regulatory approval. He also said that the company plans to pursue a parallel review pathway, seeking a simultaneous FDA approval and coverage determination for the test from the US Centers for Medicare and Medicaid Services. In the interim, the firm intends to begin offering an LDT before the end of this year, under a self-pay model with an approximately $200 price point. This would potentially put it into competition with the FDA-approved Epi proColon test, a PCR-based blood test marketed by Epigenomics at similar prices. Epi proColon, which has reported up to about 68 percent sensitivity and 80 percent specificity, has struggled to gain a foothold in clinical practice, but based on the data from CellMax’s Taiwan study, the company’s CTC methodology appears to offer improved accuracy, prompting excitement among some clinicians that the CellMax test could succeed where earlier blood tests have struggled.
“After CellMax Life’s blood test showed such impressive results at ASCO GI, we believe it can address the unmet need for a convenient, accurate, and affordable test for early colorectal cancer detection. I expect physicians will adopt it as a first-line screening option for all patients, with colonoscopy as the confirmatory diagnostic for patients who are positive per the CellMax test,” Shai Friedland, the lead PI of the newly announced CellMax study and chief of gastroenterology and hepatology a the VA’s Palo Alto Health Care System, said in a statement.
As an LDT, the CellMax test would also potentially compete with Exact Sciences’ FDA-approved stool-based genetic screening test, Cologuard, which offers about 94 percent sensitivity in detecting stage I and II cancers, but only up to 69 percent in high-grade precancers. CellMax Life’s Taiwan study data suggests it might have better performance in detecting precancers, but it remains to be seen whether the same results will hold up in the larger, more real-world cohort of its planned US follow-up.
Sharan has emphasized the potential of the test, regardless of whether it can outperform Cologuard, to improve patient outcomes via increased screening compliance. He reiterated that about a third of Americans have never been screened because current testing options, including stool-based tests, are too invasive or inconvenient.
As CellMax moves forward, the cancer screening field is also anticipating the entrance of other new tests that provide early detection via analysis of various biomarkers in blood. Freenome, for example, recently announced the commencement of its first clinical validation study, which it calls AIEMERGE, intended to support the launch of a screening test that is also being designed for use in colorectal cancer.
Information about the methodology, content, or structure of the CRC test that Freenome’s artificial-intelligence approach may yield is not yet available, but Sharan said that the evidence so far from existing approaches that profile DNA or other molecular biomarkers in blood, suggests that early cancer detection can require analyses that are much less cost-effective than the CTC approach CellMax has taken.
That said, CellMax is also continuing to explore whether there might be added value in coupling its CTC enumeration with other analytes. But according to Sharan, the results of the firm’s algorithm development work are expected to support a test that is limited to CTC enumeration and clinical variables like patient-age.
Sharan said that the company is prioritizing the newly announced colorectal cancer study, but has a number of other arms proceeding in the background. These include development of a CTC-based assay for PD-L1 expression, which the company has made available for clinical use in Asia and for research use only in the US.
According to CellMax, early data suggests that it can isolate intact CTCs in about 90 percent of non-small cell lung cancer samples, with PD-L1 positivity rates in line with what has been published in the literature from tissue analysis, and high concordance with matched tissue testing.
The firm has also presented data recently on a CTC-based prostate cancer test it is developing that can help identify or rule out cancer in men who have intermediate PSA test results, as well as provide a platform for non-invasive analysis of prognostic markers.
SUNNYVALE, Calif., May 30, 2018 /PRNewswire/ — CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, today announced it is commencing Zenith, a U.S. clinical study for its circulating tumor cell (CTC) blood test, which can transform the way colorectal cancer is detected, enabling diagnosis at its earliest, most treatable stages.
To do this, the company is first initiating a study with leading U.S. medical centers including Stanford Medicine and the U.S. Department of Veterans Affairs Palo Alto Health Care System, Johns Hopkins and University of Southern California. This U.S. trial comes on the heels of an Asian trial, for which results were announced at the 2018 ASCO Gastrointestinal Cancer Symposium (ASCO GI) in January, which demonstrated that the test can detect colorectal cancer at an early stage with accuracy ranging from 84 to 88 percent.
In this study, thousands of patients coming in for routine colorectal cancer screening via colonoscopy or stool tests will be offered CellMax Life’s blood test. The results of the blood test will be compared to those from the colonoscopy and stool tests.
“We plan to work closely with the FDA upfront to define the details of this study,” said Atul Sharan, CEO of CellMax Life. “We will also pursue reimbursement for the test by submitting it through the Parallel Review Program for approval from the FDA and coverage determination by Centers for Medicare and Medicaid Services (CMS). The test requires just a single tube of blood and is at a price point of less than $200, which makes this a very practical solution for colorectal cancer screening.”
“Colorectal cancer is among the most preventable cancers when detected early. Yet, it is the second deadliest cancer in the United States partly because of lack of compliance. One in three eligible Americans have never been screened because current testing options like colonoscopies and stool-based tests are invasive or inconvenient, deterring people from getting screened,” said Shai Friedland, M.D., Chief of Gastroenterology & Hepatology, VA Palo Alto Health Care System from the Stanford University School of Medicine, as well as lead principal investigator (PI) on this study. “After CellMax Life’s blood test showed such impressive results at ASCO GI, we believe it can address the unmet need for a convenient, accurate and affordable test for early colorectal cancer detection. I expect physicians will adopt it as a first-line screening option for all patients, with colonoscopy as the confirmatory diagnostic for patients who are positive per the CellMax test.”
While testing for CTCs has been approved and validated by the FDA as a useful detection method for late stage metastatic cancer, there has not yet been a CTC technology with the sensitivity required for early cancer detection. CellMax Life’s CMx™ ultra-sensitive CTC platform, which isolates rare CTCs present at a fraction of 1 to 10 CTCs in a background of one billion normal cells in pre-cancer and early stage cancer breaks this barrier. This platform has eight patents and is the only clinically proven CTC platform able to detect cancer early.
“The ASCO GI results showed that the blood test can detect pre-cancerous lesions at a higher sensitivity than stool tests. This is significant because these lesions can be safely and easily removed with a follow-on colonoscopy. Also, unlike home stool tests, which in our experience are only completed by around 30 percent of patients that order the kit, this test can be easily integrated into a patient’s annual physical exam, increasing compliance,” said Ashish Nimgaonkar, M.D., a gastroenterologist, medical director at the Center for Bioengineering Innovation & Design at Johns Hopkins University and one of the PIs on this study.
“An affordable test with keen sensitivity for early cancer detection like the CTC blood test has the potential to transform cancer diagnostics,” said Dr. Heinz-Josef Lenz, Medical Oncologist, Professor of Medicine at the Keck School of Medicine, USC. “The potential applications can go well beyond early detection to monitoring treatment efficacy and detect resistance to therapies, as well as for recurrence monitoring for 15 million Americans who have been diagnosed with cancer.”
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.
Under the agreement, CellMax will combine its technology for CTC isolation with IncellDx’s proprietary BioINK microfluidic reagents. Tests will be processed at CellMax’s CLIA lab in Sunnyvale, California and will be jointly marketed in the US by its sales force.
Additional terms of the agreement were not disclosed.
CellMax CEO Atul Sharan said in a statement that IncellDx’s reagent platform will bring “tremendous added value” to its tests. The first project will be to commercialize a blood-based PD-L1 assay based on analysis of both RNA and protein in captured CTCs, to be used in immunotherapy selection and monitoring.
The first generation of tests developed to measure PD-L1 required a biopsy sample of a patient’s tumor. Because blood-based testing is less invasive, easier, and can be performed repeatedly, it offers potential advantages over available assays.
CellMax and IncellDx intend to present performance data for their CTC-based PD-L1 test in non-small cell lung cancer at the annual meeting of the American Association for Cancer Research later this month.
According to the companies, the CellMax technology has been able to capture CTCs for PD-L1 testing in about 90 percent of patients across all stages of NSCLC, with about 50 percent testing PD-L1 positive.
SUNNYVALE, CALIF. (PRWEB) MARCH 28, 2018
CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, announced today the U.S. launch of a blood test to detect the expression of PD-L1 – a key protein involved in suppressing the immune system – in circulating tumor cells (CTCs). Since immunotherapies work only on a minority of patients, identifying cancer patients expressing the PD-L1 protein in CTCs can help determine if they will benefit from the treatment, sparing significant costs and potential side effects.
A study on early and late stage lung cancer patients was recently completed, and the data will be shared at the upcoming American Association for Cancer Research (AACR) conference in Chicago on April 14 through 18. The test was able to capture CTCs for PD-L1 testing in blood in about 90 percent of tested patients. Conversely, tissue can be insufficient or unavailable for testing in 25 to 50 percent of advanced lung cancer patients. About 50 percent of the CTC tested patients were PD-L1 positive; this is consistent with previously reported PD-L1 positivity rates in clinical studies.
Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis, said: “PD-L1 testing by immunohistochemistry is a standard of care as a predictive biomarker for checkpoint immunotherapy. Blood-based testing offers three potential advantages. First, about 25 percent of patients have inadequate tumor tissue upfront to test for both molecular biomarkers and PD-L1. Second, PD-L1 is a dynamic biomarker, which can change over time, so using tumor from a prior biopsy may be misleading. PD-L1 can also be unevenly distributed in tissue, leading to a false negative and denying patients the opportunity to receive immunotherapy. Lastly, looking to the future, blood-based testing provides a means for repeat testing and timely monitoring, which would not be possible otherwise. A PD-L1 blood test can overcome current issues and would be an attractive alternative to tissue testing.”
“For the 1.7 million people diagnosed with cancer annually in the United States, and the 14.8 million people living with cancer there is no affordable, non-invasive and effective way to monitor patients for treatment response or cancer recurrence,” said Atul Sharan, CEO of CellMax Life. “With the invasiveness of tissue testing and high costs and limitations of existing DNA-based liquid biopsies, conducting repeat testing has been impractical, and often, impossible. CellMax CTC blood tests offer a solution to this major unmet need. We are also seeing a lot of interest from biopharmaceutical companies who want to partner with us to de-risk their clinical trials by using CTCs to monitor patients and identify non-responders to their drug early.”
CellMax Life also analyzes circulating tumor DNA (ctDNA) in the blood sample. The combination of DNA and CTC analysis makes the CellMax liquid biopsy the first and only blood test that includes all mutation classes recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for immunotherapy and targeted therapy selection in patients with advanced solid tumors.
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 http://www.cellmaxlife.com.
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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