CellMax Life Takes Liquid Biopsy To Next Level With 73 Gene Profile CtDNA Blood Test

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.