(CGIX) Announces Launch of CALR Mutation Analysis Test

• 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

RUTHERFORD, N.J., April 4, 2014  — 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.

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