Cancer Genetics Announces Launch of CALR Mutation Analysis Test to Assist in
Diagnosis of Acute Leukemias & Myeloproliferative Neoplasms
*New Test Launch Extends CGI's Leadership in Genomic Testing for Blood
*CALR Genetic Mutation Test Will Be A Part of CGI's Comprehensive Focus on
RUTHERFORD, N.J., April 4, 2014 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc.
(Nasdaq:CGIX) ("CGI" or the "Company"), an emerging leader in DNA-based cancer
diagnostics, has launched a genetic diagnostic test for detecting mutations in
the calreticulin (CALR) gene. This test helps physicians identify patients
with certain types of myeloproliferative neoplasms (MPN), which are blood
cancers that have the potential to evolve into acute leukemia. Approximately
3 million patients in the U.S. are currently diagnosed with MPNs.CGI is one
of the first laboratories in the U.S. to offer this test under both CLIA and
In addition to having diagnostic value, the CALR mutation analysis also has
the potential to provide significant prognostic value. Patients with the CALR
mutation are understood to have more favorable disease outcomes (including
lower risk of thrombosis) as well as longer overall survival in comparison to
patients who possess other biomarkers (such as the JAK2 mutation). Therefore,
the results of the test could have implications in predicting a patient's
"CALR mutation analysis allows for a more comprehensive diagnosis of patients
with myeloproliferative neoplasms," said Dr. Lan Wang, MD, Medical Director at
Cancer Genetics. "This test can help simplify the diagnosis of MPN and may be
helpful in stratifying patients according to whether they should receive
aggressive or conservative disease management. We see CALR mutation testing
becoming one of the routine genomic tests provided to MPN patients."
Mr. Panna Sharma, CEO of Cancer Genetics added, "The CALR mutation analysis is
a valuable addition to our test menu.The availability of this test positions
CGI as one of the most comprehensive laboratories in the U.S. for MPN and
acute leukemia.In launching this test, we responded quickly to demand from
the clinical community, demonstrating our ability to rapidly adapt in a
fast-paced, evolving environment."
Myeloproliferative neoplasms (MPN) are a related group of blood cancers that
are characterized by the overproduction of mature blood cells.^1 Recent
advances in research have demonstrated that mutations in the CALR gene can
serve as an important biomarker in the diagnosis of two subtypes of patients
with MPN: Essential Thrombocythemia (ET) and Primary Myelofibrosis (PMF) ^2,
3. CALR mutations do not appear to occur in patients with JAK2andMPL
mutations, which are other well established biomarkers in leukemia.
The value of Calreticulin (CALR) to serve as a biomarker was demonstrated in
two independent studies by leading researchers that were conducted last year
and published simultaneously in the New England Journal of Medicine ^2, 3.
Both studies were also presented as late breaking abstracts at the 55th annual
meeting of the American Society of Hematology (ASH).
About Cancer Genetics:
Cancer Genetics, Inc. is an emerging leader in DNA-based cancer diagnostics,
servicing some of the most prestigious medical institutions in the world. Our
tests target cancers that are difficult to diagnose and predict treatment
outcomes. These cancers include hematological, urogenital and HPV-associated
cancers. We also offer a comprehensive range of non-proprietary
oncology-focused tests and laboratory services that provide critical genomic
information to healthcare professionals, as well as biopharma and biotech
companies. Our state-of-the-art reference lab is focused entirely on
maintaining clinical excellence and is both CLIA certified and CAP accredited
and has licensure from several states including New York State. We have
established strong research collaborations with major cancer centers such as
Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National
Cancer Institute. For further information, please see www.cancergenetics.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 future financial and/or operating results, future growth in
research, technology, clinical development and potential opportunities for
Cancer Genetics, Inc. products and services, along with other statements about
the future expectations, beliefs, goals, plans, or prospects expressed by
management 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, 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 Company's Form 10-K for the
year ended December 31, 2013 and other filings with the Securities and
Exchange Commission. These forward-looking statements speak only as of the
date hereof. Cancer Genetics disclaims any obligation to update these
1.Swerdlow SH, Campo E, Harris NL, et al. WHO classification of tumours of
haematopoietic and lymphoid tissue. Lyon, France: IARC Press, 2008.
2.Klampfl T, Gisslinger H, Harutyunyan AS, et al. Somatic mutations of
Calreticulin in myeloproliferative neoplasms. N Engl J Med 2013; 369:2379-90.
3.Nangalia J, Massie CE, Baxter EJ, et al. Somatic CALR mutations in
myeloproliferative neoplasms with nonmutated JAK2. N Engl J Med 2013;
CONTACT: Investor Relations
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