NeoGenomics is the First Laboratory to Offer Calreticulin (CALR) Mutation Testing for the Diagnosis and Classification of Myeloproliferative Neoplasms

FT. MYERS, Fla., Jan. 7, 2014 /PRNewswire/ -- NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today that it has validated and launched a new test for the detection of mutations in the calreticulin (CALR) gene.  The CALR gene is a novel biomarker that was reported to be specific for myeloproliferative neoplasms (MPN) for the first time at the annual meeting of the American Society of Hematology (ASH) last month.  Since then, findings on the CALR gene have been published in the three articles referenced below.

Based on data contained in the referenced papers and on its own retrospective validation data, NeoGenomics believes the presence of CALR mutation is pathogenic and pathognomonic for myelofibrosis and essential thrombocythemia, and is detected in a majority of cases that lack JAK2/MPL mutations.  These findings suggest that patients suspected of having MPN should be tested for CALR mutation if they lack JAK2/MPL mutations.  The company believes that CALR testing is not only important for the diagnosis and classification of MPN, but also for prognosis.

Doug VanOort, the company's Chairman and CEO, said "NeoGenomics is proud to be the first laboratory in the United States to offer CALR testing on a clinical basis.  This effort to quickly develop and offer important new tests to Physicians across the country demonstrates our commitment to be a leader in molecular oncology."

Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented, "Offering CALR mutation testing compliments our comprehensive testing for patients with MPN.  We now offer the most comprehensive, clinically relevant testing for MPN, including JAK2, MPL, CALR, CBL, PTPN11, CSF3R, TET2, ASXL1, and SF3B.  This allows Physicians to precisely diagnose, classify and treat patients based on the biology of the disease."    

MPN is estimated to affect approximately 300,000 people in the United States with an incidence rate of approximately 9.5 cases per 100,000 people annually.  MPN is a relatively slow progressing myeloid malignancy characterized by increases in one or more blood elements such as hemoglobin, platelets, and white blood cells.  MPN can be subclassified to polycythemia vera, essential thrombocythemia, myelofibrosis and other less common diseases.  Proper diagnosis and subclassification is very important for appropriate management and control, and in preventing progression to more acute forms, of the disease.

NeoGenomics' CALR mutation testing is currently available to be ordered with special handling procedures, and will be launched broadly by the end of January.  Until reimbursement is established by government and commercial payers, the test is being offered on a patient pay basis to those patients who have signed an Advance Beneficiary Notice (ABN) form.  Questions about ordering the CALR mutation test should be referred to any NeoGenomics sales representative or directed to the Customer Care Department at (866) 776-5907.

About NeoGenomics, Inc.

NeoGenomics, Inc. is a high-complexity CLIA–certified clinical laboratory that specializes in cancer genetics testing, the fastest growing segment of the laboratory industry.  The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, morphology studies, anatomic pathology and molecular genetic testing.  Headquartered in Fort Myers, FL, NeoGenomics has labs in Nashville, TN, Irvine, CA, Tampa, FL and Fort Myers, FL.  NeoGenomics services the needs of pathologists, oncologists, urologists and other clinicians, and hospitals throughout the United States. For additional information about NeoGenomics, visit http://www.neogenomics.com. 

Forward Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in the foregoing are forward-looking statements.  These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward looking statements.  Actual results could differ materially from such statements expressed or implied herein. Factors that might cause such a difference include, among others, the company's ability to continue gaining new customers, offer new types of tests, and otherwise implement its business plan. As a result, this press release should be read in conjunction with the company's periodic filings with the SEC.

References:

1. Nangalia J, Massie CE, Baxter EJ, et al. Somatic CALR mutations in myeloproliferative neoplasms with nonmutated JAK2. N Engl J Med. 2013 Dec 19; 369(25):2391-405.
   
   
2. Klampfl T, Gisslinger H, Harutyunyan AS, et al. Somatic mutations of calreticulin in myeloproliferative neoplasms.   N Engl J Med. 2013 Dec 19; 369(25):2379-90. doi: 10.1056/NEJMoa1311347. Epub 2013 Dec 10.
   
   
3. Rotunno G, Mannarelli C, Guglielmelli P, et al. Impact of Calreticulin Mutations on Clinical and Hematological Phenotype and Outcome in Essential Thrombocythemia. Blood. 2013 Dec 26 (Epub ahead of print).

SOURCE NeoGenomics, Inc.