Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision
medicine for oncology through molecular markers and diagnostics,
today announced that it has received special 510(k) clearance from
the U. S. Food and Drug Administration (FDA) for its Tissue of
Origin test (TOO®) following modifications made to test reagents
and software.
TOO® is a microarray-based gene expression test that analyzes a
tumor’s genomic information to help identify its origin, which is
valuable in classifying metastatic, poorly differentiated, or
undifferentiated cancers. TOO® assesses 2,000 individual genes,
covering 15 of the most common tumor types (representing 58
morphologies) and 90% of all solid tumors [1]. These tumors include
thyroid, breast, non-small cell lung, pancreas, gastric,
colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma,
melanoma, ovarian, sarcoma, testicular germ cell, and prostate.
TOO® is the only FDA-cleared test of its type and is
Medicare-reimbursed. It is also the only test that provides a
pathologist’s review and interpretation of a patient’s test results
and diagnosis. TOO® provides extensive analytical and clinical
validation for statistically significant improvement in accuracy
over other methods, including IHC [2]. TOO® results lead to a
change in patient treatment 65% of the time. In challenging
cancers that require a second round of IHC, TOO® increases
diagnostic accuracy and confidence in site-specific treatment
decisions [1].
“Our TOO® Test represents a unique offering with the ability to
add significant value to the continuum of care for cancer patients
and greatly enhance our biopharma partners’ development efforts.
This 510(k) clearance represents an important milestone toward our
goal of gaining broad adoption of the test,” said John A. (Jay)
Roberts, Interim Chief Executive Officer and COO of Cancer
Genetics. “An important element of our recently implemented
transformation strategy is the identification of new methods
through which to monetize our world-class test portfolio. We are
currently evaluating several partnering opportunities that would
expand the reach of the TOO® Test and have the potential to
generate high-margin revenue streams. We look forward to continuing
this process as we leverage the capabilities of TOO® to drive
future growth.”
Compared to the early version, the current TOO® assay uses new
labeling reagents and has a higher accuracy rate and a shorter
workflow with similar precision and reproducibility. The low RNA
input requirement of the early version is maintained. The combined
result of these new features offers a further optimized clinical
assay to help clinicians make diagnostic decisions and subsequent
treatment selections.
Rita Shaknovich, Chief Medical Officer of CGI
added, “Despite increasing excellence in the diagnostic workup
for malignancies, there are approximately 150,000 newly diagnosed
cases of metastatic cancer with unclear diagnosis in the U.S. and
Europe each year [3]. This includes the subset of patients with
cancers of unknown primary (CUP) and of uncertain origin.
Increasingly complex algorithms and testing associated with a
diagnostic workup also means that many challenging cases have
insufficient amount of sample material for analysis. CGI’s TOO®
aids in identifying the source of such challenging tumors while
using less material, and could be used as a diagnostic or
confirmatory tool both for routine clinical testing and for
clinical trial enrollment of patients with such tumors, enabling
them to be considered for novel drug therapies.”
The Company announced on April 2, 2018 that it has engaged
Raymond James & Associates, Inc. as a financial advisor to
assist with evaluating options for the Company’s strategic
direction. These options may include raising additional capital,
the acquisition of another company and / or complementary assets,
the sale of the Company, or another type of strategic
partnership. The Company’s Board of Directors is committed to
evaluating all potential strategic opportunities and to pursuing
the path most likely to create both near- and longer-term value for
Cancer Genetics’ shareholders.
1. R Pillai, et al. Validation and Reproducibility of a
Microarray-based Gene Expression Test for Identifying the Primary
Site of Tumors in Formalin-Fixed Paraffin-Embedded Specimens. J
Molec Diag 13 2011;13:48-56.
2. JP Grenert, et al. Gene Expression Profiling from
Formalin-Fixed, Paraffin-Embedded Tissue for Tumor Diagnosis. Clin
Chim Acta. 2011 Jul 15;412(15-16):1462-4.
3. Tomuleasa, Ciprian, et al. How to Diagnose and Treat a Cancer
of Unknown Primary Site. Journal of Gastrointestinal & Liver
Diseases 26.1 (2017).
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
MEDIA RELATIONSKirsten Thomas 508-280-6592
kthomas@theruthgroup.com
INVESTOR RELATIONSLee Roth 646-536-7012
lroth@theruthgroup.com
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, 2017 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.
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