NeoGenomics launches new test for detection of mutations in CALR gene

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.