Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The
Company”), a leader in enabling precision medicine for
oncology through molecular markers and diagnostics, announced today
the launch of Thermo Fisher Scientific's (Thermo Fisher) Oncomine
Dx Target - the first next-generation sequencing (NGS)-based
Companion Diagnostic (CDx) test that simultaneously screens tumor
samples for biomarkers associated with three FDA-approved therapies
for non-small cell lung cancer (NSCLC). CGI is one of the first
laboratories, one of only three, in the USA to offer Thermo
Fisher’s Oncomine Dx Target Test.
Lung cancer is by far the leading cause of cancer death among
both men and women; about 1 out of 4 cancer deaths are from lung
cancer. It is the second most common cancer in both men and women
(not counting skin cancer). About 14% of all new cancers are lung
cancers, with NSCLC accounting for 85% of all lung cancers.[1] It
is estimated that in 2017, approximately 222,500 Americans will be
diagnosed with lung cancer, and almost 156,000 will die from this
disease.[2]
Approved by the FDA on June 22 of 2017, the Oncomine Dx
Target Test simultaneously evaluates 23 genes clinically
associated with NSCLC. Following FDA approval, results from
analysis of three of these genes can now be used to identify
patients who may be eligible for treatment with one of the
following: AstraZeneca's EGFR inhibitor Iressa (gefitinib),
Pfizer's ALK and ROS1 inhibitor Xalkori (crizotinib), and the
combination therapy of Novartis' MEK inhibitor Mekinist
(trametinib) and RAF inhibitor Tafinlar (dabrafenib). With this
test, physicians can now match patients to these therapies in days
instead of several weeks, which it often takes when screening
samples one biomarker at a time.
Recognized as Thermo Fisher's NGS CDx Center of Excellence, CGI
is among the first 3 laboratories that will offer the Oncomine Dx
Target Test as a service to oncologists. All tests will be run on
Thermo Fisher's Ion PGM Dx System, which received FDA 510(k)
clearance in parallel for use on formalin-fixed, paraffin-embedded
(FFPE) tissue samples. The Oncomine Dx Target Test is a kit and
requires as little as 10 nanograms of DNA from FFPE tissues samples
- a critical advantage of the test, given the challenge of NSCLC
patient samples often being of limited quantity.
The test report will not only indicate whether patients have
ROS1, EGFR, and BRAF alterations linked to the three FDA-approved
treatments, but also the presence or absence of gene variants in 20
other genes associated with NSCLC that are currently investigated
in clinical trials and potentially actionable in the
future.
Dr. Shereen Gheith, Chief of Section of Molecular Pathology and
Section of Hematopathology at Health Network Laboratories stated,
"The Oncomine Dx Target Test is an important new capability for the
global medical community and another significant step in the growth
of CGI as an extremely qualified resource for the management of
cancer patients nationwide. CGI's 21st century molecular
technologies, speed, and world-class medical environment bring
increased hope to cancer patients for improved outcomes."
"We are very pleased to be able to add the Oncomine Dx Target
Test to our comprehensive menu of cutting edge diagnostic services
available to physicians, and to be one of the first 3 labs to
provide rapid access to this test. NGS has revolutionized cancer
research by providing a comprehensive method of detecting genomic
alterations associated with somatic cancer. By becoming a companion
test, the Oncomine Dx Target Test represents an important advance
in precision medicine as a rapid and comprehensive tool guiding
clinicians in treatment decision-making. CGI has an extensive
heritage in biomarker and molecular profiling for lung cancer. The
addition of this comprehensive new CDx to our test menu will aid in
further streamlining of our operations to get results in a rapid
timeframe so that the patients don’t have to wait, in contrast to
the sequential testing approach," said CGI President and CEO Panna
Sharma.
According to Thermo Fisher, this initial approval will enable
the company to work quickly to expand the test's indications into
new drug/biomarker combinations, including applications beyond lung
cancer.
[1] Julian R. Molina, et al. Non–Small Cell Lung Cancer:
Epidemiology, Risk Factors, Treatment, and Survivorship. Mayo
Clin Proc. 2008 May; 83(5): 584–594.
[2] American Cancer Society, Cancer Facts and Figures 2017;
page18. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf
ABOUT CANCER GENETICS Cancer Genetics Inc. is a
leader in enabling precision medicine in oncology from bench to
bedside through the use of oncology biomarkers and molecular
testing. CGI is developing a global footprint with locations in the
US, India and China. We have established strong clinical research
collaborations with major cancer centers such as Memorial Sloan
Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of
Medicine at USC and the National Cancer Institute.
The Company offers a comprehensive range of laboratory services
that provide critical genomic and biomarker information. Its
state-of-the-art reference labs are CLIA-certified and
CAP-accredited in the US and have licensure from several states
including New York State.
For more information, please visit or follow CGI at:
Internet: www.cancergenetics.com
Twitter: @Cancer_Genetics
Facebook: www.facebook.com/CancerGenetics
Forward-Looking Statements: This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
pertaining to Cancer Genetics Inc.’s expectations regarding the
completion, timing, pricing and size of the offering described in
this press release constitute forward-looking statements.
Any statements that are not historical fact (including, but not
limited to, statements that contain words such as “will,”
“believes,” “plans,” “anticipates,” “expects,” “estimates”) should
also be considered to be forward-looking statements.
Forward-looking statements involve risks and uncertainties,
including, without limitation, risks inherent in the development
and/or commercialization of potential products, risks of
cancellation of customer contracts or discontinuance of trials,
risks that anticipated benefits from acquisitions will not be
realized, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital,
maintenance of intellectual property rights and other risks
discussed in the Cancer Genetics, Inc. Form 10-K for the year ended
December 31, 2015 and the Form 10-Q for the Quarter ended March 31,
2016 along with other filings with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date hereof. Cancer Genetics, Inc. disclaims any obligation to
update these forward-looking statements.
Media Contact:
Panna Sharma
Cancer Genetics, Inc.
Tel: 201-528-9200
Email: panna.sharma@cgix.com
Investor Relations Contact:
Richard Moyer
Cameron Associates
535 Fifth Ave., New York, NY 10017
Tel: 212-554-5466
Email: richard@cameronassoc.com
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