NeoGenomics Launches Twelve NeoLAB™ 'Liquid Biopsy' Tests For Hematologic Diseases

Fort Myers, FL /PRNewswire/ - NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today the launch of its first twelve tests in a new line of "liquid biopsy" or NeoLAB™ assays using next generation sequencing and other advanced molecular technologies. These twelve new tests use cell-free circulating DNA and RNA found in blood plasma to identify molecular abnormalities in the bone marrow without the need for a bone marrow biopsy.

It is estimated that more than 600,000 bone marrow biopsies are performed annually in the U.S. to diagnose and monitor patients with various hematologic cancers. However, bone marrow biopsies are a painful and uncomfortable procedure for patients, and can be associated with complications. These new tests are designed to help patients by reducing the need for bone marrow biopsies, and to assist clinicians in their treatment of cancer patients.

The technology is based on the concept that hematologic cells release their DNA, RNA, and protein into circulation as the cells are immersed in blood. The cell-free circulating DNA, RNA and protein are referred to as exosomes, microvesicles, apoptotic bodies or simply DNA- or RNA-protein complexes. Our new tests use proprietary methods to extract these circulating nucleic acids and analyze them using next generation sequencing and advanced methods in order to evaluate molecular abnormalities present in hematological cancers.

Physicians can utilize the new liquid biopsy tests to: 1) Screen patients to determine if a bone marrow biopsy is necessary, especially when myelodysplastic syndrome or acute leukemia is suspected; 2) Monitor disease status, response to therapy and predict early relapse; and 3) Complete testing when a bone marrow sample is inadequate or is technically difficult to obtain.

Douglas VanOort, NeoGenomics' Chairman and Chief Executive Officer, stated, "We are very pleased to launch this new line of liquid biopsy testing as we continue to seek innovative ways to improve patient care. These novel tests provide new tools for clinicians to better diagnose their patients and more efficiently monitor the effectiveness of therapy. At the same time, we believe this new line of testing can help to reduce the overall cost of cancer care by reducing unnecessary bone marrow biopsies."

Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented, "Liquid biopsy, as an alternative to bone marrow biopsy, is not only convenient for patients and physicians, but in many situations can be more accurate than bone marrow biopsies in evaluating molecular abnormalities. A bone marrow core biopsy, by its nature, is blinded and may miss the disease in bone marrow when it is patchy. It has been demonstrated in multiple published studies that, in a proper clinical setting, cell-free DNA/RNA in plasma is relatively enriched by tumor-specific DNA and RNA."

The current NeoLAB™ liquid biopsy line of testing includes: MDS/CMML profiling, AML profiling, FLT3 mutation analysis, NPM1 mutation analysis, IDH1/IDH2 mutation analysis, NRAS mutation analysis, KRAS mutation analysis, and translocations of PML-RARA, RUNX1-RUNX1T1, and Inv16.

References:

1. Giles FJ, Albitar M. Plasma-based testing as a new paradigm for clinical testing in hematologic diseases. Expert Review of Molecular Diagnostics. 2007 Sep;7(5):615-23.
2. Jilani I, Estey E, Manshuri T, Caligiuri M, Keating M, Giles F, Thomas D, Kantarjian H, Albitar M. Better detection of FLT3 internal tandem duplication using peripheral blood plasma DNA. Leukemia. 2003 Jan;17(1):114-119.
3. Rogers A, Joe Y, Dey A, Jilani I, Giles F, Estey E, Freireich E, Keating M, Kantarjian H, Albitar M. Relative increase in leukemia-specific DNA in peripheral blood plasma from patients with acute myeloid leukemia and myelodysplasia. Blood. 2004 Apr 1;103(7):2799-801.
4. Ma W, Kantarjian H, Jilani I, Gorre M, Bhalla K, Ottmann O, Giles F, Albitar M. Heterogeneity in detecting Abl kinase mutations and better sensitivity using circulating plasma RNA. Leukemia. 2006 Nov;20(11):1989-91.
5. Ma W, Tseng R, Gorre M, Jilani I, Keating M, Kantarjian H, Cortes J, O'brien S, Giles F, Albitar M. Plasma RNA as an alternative to cells for monitoring molecular response in patients with chronic myeloid leukemia. Haematologica. 2007, Feb; 92(2): 170-5.
6. Ma W, Kantarjian H, Zhang X, Sun W, Buller AM, Jilani I, Schwartz JG, Giles F, Albitar M. Higher detection rate of JAK2 mutation using plasma. Blood. 2008 Apr 1;111(7):3906-7.
7. Ma W, Kantarjian H, O'Brien S, Jilani I, Zhang X, Estrov Z, Ferrajoli A, Keating M, Giles F, Albitar M. Enzymatic activity of circulating proteasomes correlates with clinical behavior in patients with chronic lymphocytic leukemia. Cancer. 2008 Mar 15;112(6):1306-12.
8. Ma W, Kantarjian H, Zhang X, Jilani I, Sheikholeslami MR, Donahue AC, Ravandi F, Estey E, O'Brien S, Keating M, Giles FJ, Albitar M. Detection of nucleophosmin gene mutations in plasma from patients with acute myeloid leukemia: clinical significance and implications. Cancer Biomarkers. 2009;5(1):51-8.
9. Yeh CH, Tseng R, Albitar M. Plasma-based detection of clonality in lymphoid malignancies. European Journal of Haematology. 2009 Jun;82(6):450-3.
10. Ma W, Zhang X, Wang X, Zhang Z, Yeh CH, Uyeji J, Albitar M. MPL mutation profile in JAK2 mutation-negative patients with myeloproliferative disorders. Diagnostic Molecular Pathology. 2011 Mar;20(1):34-9.
11. Ferras Albitar, Wanlong Ma, Kevin Diep, Ivan De Dios, Sally Agersborg, Maya Thangavelu, Steve Brodie, and Maher Albitar. Deep Sequencing of Peripheral Blood Plasma DNA As a Reliable Test for Confirming the Diagnosis of Myelodysplastic Syndrome. [Abstract]. Blood, 2014: 124 (21). Abstract 1909.
12. Kevin Diep, Wanlong Ma, Ferras Albitar, Ivan De Dios, Sally Agersborg, Maya Thangavelu, Steve Brodie, and Maher Albitar, Determining Tumor Load and Biallelic Mutation in Patients with CALR Mutation Using Peripheral Blood Plasma. [Abstract]. Blood, 2014: 124 (21). Abstract 1818.

About NeoGenomics, Inc.
NeoGenomics, Inc. operates a network of CLIA–certified clinical laboratories that specialize 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, anatomic pathology and molecular genetic testing. NeoGenomics services the needs of pathologists, oncologists, other clinicians and hospitals throughout the United States, and has laboratories in Nashville, TN; Irvine, Fresno and West Sacramento CA; and Tampa and Fort Myers, FL.

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.