Cancer Genetics Announces Launch of CALR Mutation Analysis Test to Assist in Diagnosis of Acute Leukemias & Myeloproliferativ...
April 04 2014 - 8:00AM
- New Test Launch Extends CGI's Leadership in Genomic Testing for
Blood Cancers
- CALR Genetic Mutation Test Will Be A Part of CGI's
Comprehensive Focus on Leukemia
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
NY-State Approvals.
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 outlook.
"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
JAK2 and MPL 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 forward-looking statements.
References:
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; 369:2391-405.
CONTACT: Investor Relations
Michael Rice
Life Science Advisors LLC
646-597-6979
Media Relations
RedChip Companies, Inc.
Paul Kuntz, 800-733-2447, ext. 105
paul@redchip.com
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