WESTLAKE VILLAGE, Calif.,
April 11, 2018 /PRNewswire-PRWeb/ --
MD Anderson and Cynvenio Biosystems, Inc. today announce the
beginning of the final clinical validation phase of Cynvenio
LungLB(TM). LungLB(TM) definitively answers whether patients with
indeterminate lung nodules have cancer or not from a simple blood
draw. The MD Anderson led study continues on successful data
achieved on LungLB(TM) showing a sensitivity of 91% and specificity
of 93% in patients with indeterminate lung nodules who are
candidates for biopsy.
"LungLB(TM) has the potential to provide clarity for a large of
number of patients where we see a nodule on a CT scan, but it's not
clear whether or not there is cancer," said Joshua Kuban, M.D., assistant professor of
interventional radiology MD Anderson and lead investigator. "This
is a critical issue in the front-end management of lung cancer that
creates considerable patient anxiety and where the surgical
procedure is not without risk."
"I have myself had several failed biopsies and had to put off
treatment for a month," shares Bonnie
Addario, lung cancer survivor, Founder and Chair, Bonnie J.
Addario Lung Cancer Foundation. "A blood test to determine whether
small nodules are malignant or not can prevent months of putting
your life 'on hold' and needless worry."
The current standard for early lung cancer detection is subject
to a high false positive rate that ultimately results in thousands
of unnecessary invasive and dangerous biopsies being performed each
year. Cynvenio's LungLB(TM) test is designed to confirm the
presence of cancer in patients with indeterminate lung nodules
following low-dose CT, as studies have shown that nearly half of
patients who receive biopsy following identification of a
suspicious nodule do not have lung cancer†.
Studies have shown significant and lasting psychological impact
to patients following negative biopsy. In addition to using the
test as a risk-stratification tool, Cynvenio is determined to
identify the utility of the test as a monitoring tool for these
patients to provide peace of mind between scans.
The Cynvenio LiquidBiopsy® platform has many features unique to
the field of circulating tumor cells including the ability to get a
pure eluate of positively selected cells for advanced single cell
and NGS testing. The platform has now been adapted to run the
LungLB(TM) test and is teamed with an advanced cytoinformatics
capability to reduce analysis times.
LungLB(TM) is currently being implemented by Cynvenio's Joint
Venture in China, Cynvenio-Livzon
Diagnostics, on an estimated 3,000 Chinese patients with
indeterminate nodules.
NCCN Guidelines now currently recommend considering the use of
liquid biopsy in NSCLC patients to assess mutations predictive of
response to targeted therapy. With LungLB(TM), clinicians will have
another non-invasive tool to obtain information that will help with
clinical decision making. Within its CLIA certified CAP accredited
laboratory, Cynvenio provides doctors with comprehensive
non-invasive tools for lung cancer spanning early to late stage
diagnosis.
For additional information or to order the test, please contact
Cynvenio at 888-885-1172.
About Cynvenio Biosystems, Inc.
Cynvenio's liquid biopsy testing technology is leading the way
to more affordable and clinically actionable precision medicine
strategies for cancer patients. Among the company's breakthroughs
is its line of ClearID® tests for greatly improved cancer detection
and monitoring via a patient-friendly blood draw, and a suite of
proprietary, distributable LiquidBiopsy® platforms and consumables
for deployment in hospitals and third party diagnostic labs.
Cynvenio is based in Westlake Village,
California. For more information, please visit
https://www.cynvenio.com/, https://www.clearidmonitoring.com/, and
https://www.liquidbiopsy.com/.
LiquidBiopsy® and ClearID® are registered trademarks of Cynvenio
Biosystems, Inc.
†Lokhandwala et al. Costs of Diagnostic Assessment for Lung
Cancer: A Medicare Claims Analysis (2016)
SOURCE Cynvenio Biosystems, Inc.