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
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
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
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
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.
1.Nangalia J, Massie CE, Baxter EJ, et al. Somatic CALR mutations in
myeloproliferative neoplasms with nonmutated JAK2. N Engl J Med. 2013 Dec
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.
Contact: NeoGenomics, Inc., Steven C. Jones, Director of Investor Relations,
(239) 325-2001, firstname.lastname@example.org, Hawk Associates, Inc., Ms. Julie
Marshall, (305) 451-1888, email@example.com
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