Cynvenio Honors Triple Negative Breast Cancer Day with Clinical Trial Launch and Event at Pink Lotus Breast Center in Los Angeles

Non-invasive ‘Liquid Biopsy’ Technology May Provide Early Warning
System for Metastasis and Lead to Improved Targeted Outcomes

LOS ANGELES–(BUSINESS WIRE)–Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling
the new era of individualized medicine for all cancer patients, today
will honor Triple
Negative Breast Cancer Day
by launching a clinical trial for women
with triple negative breast cancer (TNBC) using the company’s
non-invasive liquid biopsy technology to monitor participants and
identify early signs of metastasis. An event for breast cancer
advocates, including women with the disease and those enrolling in the
trial, will take place this morning in Beverly Hills at the Pink Lotus
Breast Center – the first site to participate in the nationwide study.

Of the estimated one million cases of breast cancer diagnosed annually
worldwide, some 170,000 or more will have the TNBC subtype, which means
these women test negative for estrogen receptor, progesterone receptor,
and Her-2 receptor gene expression. Despite a relatively favorable
response rate to chemotherapy, TNBC-classified patients are more likely
to develop distant recurrence and die from breast cancer within five
years of diagnosis compared with other patients, and one-third of all
TNBC patients will eventually develop metastatic disease. Younger women,
African Americans, and Latinas are at highest risk.

“Currently there is no effective way to monitor women who have completed
standard therapy for TNBC and who remain at high risk of recurrence and
metastases.” said Paul Y. Song, MD, Chief Medical Officer of Cynvenio.
“Our LiquidBiopsy®-based solution, which uses a simple blood
draw and includes monitoring a woman’s immune system for signs of cancer
recurrence, may help find cancerous cells well before they embed
themselves into organs or bone. These cells can then be analyzed to
identify specific targeted therapies in hopes of improving outcomes.”

“We strive to provide the highest quality breast care medically and
technologically possible, so we are excited to be the first center in
the country to participate in this cutting-edge research,” said Kristi
Funk, MD, Founder of the Pink Lotus Breast Center. “The ‘watch and wait’
plan is not reassuring to our patients; therefore, our goal is to
provide women a better method for monitoring their health, and
hopefully, cancer-free existence.”

André de Fusco, Cynvenio’s Chief Executive Officer added: “This trial is
an important milestone for our company and for the field of breast
cancer research. It represents the culmination of four years of intense
bioengineering development and we are thrilled to support Drs. Funk and
Song in their quest to change the patient monitoring paradigm. Most
importantly we hope our work will lead to tangible improvements in the
standard of care for triple negative breast cancer survivors. ”

About the Trial

The new study will use Cynvenio’s ClearID genomic test, powered
by its LiquidBiopsy® technology, in combination with the NK
Vue blood test from ATGen Global, which is distributed by
Cynvenio in the U.S. The NK Vue test monitors the immune system –
specifically the presence of natural killer (NK) cells – and can be used
as a tool for assessing changes in patients with conditions where innate
NK cell activity has been shown to be reduced, such as in some types of
cancer. There has been a strong correlation between low NK cell activity
and increased presence of circulating tumor cells. In this study,
patients who show low NK levels will receive further analysis with the
ClearID test to molecularly characterize circulating tumor cell and
cell-free DNA present in their blood for genetic alterations that may
support specific treatment regimens. More information about the trial is
available at https://clinicaltrials.gov/show/NCT02639832.

Editor’s Note:

Media interested in attending the event can contact Nicole Litchfield at Nicole@bioscribe.com
or 415-793-6468.

About Cynvenio Biosystems, Inc.

Cynvenio is a commercial stage clinical diagnostics company that
leverages its proprietary LiquidBiopsy® multi-template
technology for the molecular characterization of tumor cells from a
standard blood draw. Commercial labs and research institutions are
powered by Cynvenio’s LiquidBiopsy platform, which includes automated
instrumentation, consumables/reagents, patient sample kits, and
bioinformatics for sequencing rare cell populations. Oncology practices
and individual physicians can also access the LiquidBiopsy system with
zero upfront investment by ordering the ClearID™ blood test from
Cynvenio’s CLIA/CAP lab or its clinical partners. ClearID and
LiquidBiopsy are cornerstones in the emerging field of genomic
peripheral blood monitoring. They are used to rapidly assess patients’
evolving mutations in support of precision medicine strategies. ClearID
is reimbursable in the United States.

Cynvenio is headquartered in Westlake Village, California (Los Angeles).
For more information, please visit http://www.cynvenio.com and www.liquidbiopsy.com.

LiquidBiopsy® is a registered trademark and ClearID™ is a trademark
of Cynvenio Biosystems, Inc.

NK Vue™ is a registered trademark of ATGen Ltd. (Seoul, Korea)

Contacts

Bioscribe, Inc.
Nicole Litchfield, 1-415-793-6468
Nicole@bioscribe.com

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