CellMax Life Takes Liquid Biopsy to Next Level with 73 Gene Profile ctDNA Blood Test

04-Jan-2017 Intellasia | BusinessWire | 11:00 AM Print This Post

CellMax-LBx Liquid Biopsy Assists with Tumor Treatment Response &
Recurrence Monitoring

SUNNYVALE, Calif.–(BUSINESS WIRE)–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

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

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. For more information, please visit: https://cellmaxlife.com/liquid-biopsy-lbx/

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.


LaunchM, Inc.
Gloria Nichols, +1 650-678-2219
[email protected]


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