NeoGenomics introduces NeoLAB Solid Tumor Monitor, NeoLAB BTK Inhibitor Acquired Resistance test

Dec 8 2015

NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today an expansion of its liquid biopsy testing menu to include two new tests, a NeoLAB^™ Solid Tumor Monitor and a NeoLAB^™ BTK Inhibitor Acquired Resistance test. Each of the new tests uses cell-free DNA (cfDNA) from peripheral blood plasma without the need for tissue biopsies.

The NeoLAB^™ Solid Tumor Monitor is designed to quantify and track genomic abnormalities in tumors using cfDNA. It is offered to help the treating physician monitor cancer patients to evaluate response to therapy. Information from the liquid biopsy test can also be used to capture the heterogeneity in the cancer, monitor the emergence of new resistant clones, and predict relapse. Because this liquid biopsy test may not be appropriate for some patients with early disease, NeoLAB^™ Solid Tumor Monitor testing is restricted to patients with documented metastatic cancer who carry specific molecular abnormalities that were confirmed at NeoGenomics by tissue biopsy testing. Testing of cfDNA in this subgroup of patients is performed using next generation sequencing (NGS) along with a propriety high-sensitivity procedure, which significantly increases NGS sequencing sensitivity.

The NeoLAB^™ BTK Inhibitor Acquired Resistance test is designed to predict resistance to Bruton Tyrosine Kinase (BTK) inhibitors using highly-sensitive proprietary technology developed at NeoGenomics. Resistance to BTK inhibitors is associated with mutations in the BTK and PLCG2 genes. This new test is capable of detecting mutations in these two genes prior to tissue or cell-based testing. The test can be used to monitor patients treated with BTK inhibitors, especially in chronic lymphocytic leukemia (CLL), mantle cell lymphoma and diffuse large B-cell lymphoma (DLBL). Using this methodology, mutations in BTK and PLCG2 can be detected approximately 2 to 12 months prior to the appearance of overt clinical resistance to therapy. Early detection of potential resistance may alert the treating physician to develop a new strategy for therapy or for a combination of therapies that may overcome resistance. The work and data confirming the clinical validity of this important test was selected for oral presentation at the December 2015 American Society of Hematology (ASH) annual meeting in Orlando, FL.

Douglas VanOort, NeoGenomics' Chairman and Chief Executive Officer, stated "The added medical value that liquid biopsies provide is now well-recognized. These new tests bring our menu of innovative liquid biopsy offerings to a total of 15 tests and demonstrate our commitment to being a leader in personalized medicine testing in order to improve patient care."

Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented "When properly used, liquid biopsies can provide very important information in managing solid tumors as well as hematologic neoplasms. Our goal for these two new tests is to help physicians make the proper change in therapy and replace expensive drugs that are not working with drugs that have the potential to work. Our proprietary advances in NGS allow us to increase the sensitivity of this important technology and make these liquid biopsy offerings possible."

SOURCE NeoGenomics, Inc.