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:

1. 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.

2. 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.

3. 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 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.