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.