NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today the launch of a new line of germline cancer predisposition testing services. The new tests include comprehensive testing for BRCA1 and BRCA2 encompassing an analysis of all exons and adjacent intronic regions. The testing encompasses point mutations, indels (small insertions/deletions), and large deletions and insertions. In addition, the company is launching a 73 multigene panel for testing patients with a strong family history of inherited cancer, but who have no evidence of BRCA1 or BRCA2 mutation.
The new BRCA1 and BRCA2 testing has also been integrated into new cancer profile tests for breast, ovarian and pancreatic cancer. In addition to testing patients with cancer, these tests may be used to screen patients to determine if they carry these mutations. Carriers of BRCA1 or BRCA2 mutations have higher incidence of contralateral breast cancer, ovarian cancer, pancreatic cancer, male breast cancer, fallopian tube cancer, peritoneal tumor, prostate cancer, and melanoma. This testing provides important information not only for long term management of patients, but also for determining appropriate treatments using recently approved therapies.
The Company also announced that it has launched germline testing for Lynch Syndrome, also known as Hereditary Non-Polyposis Colorectal Cancer (HNPCC). This testing includes comprehensive analysis for point mutations, indels, and large deletions/insertions in MLH1, MSH2, EPCAM, MSH6, and PMS2 genes. This offering complements the company's HNPCC screening using immunohistochemistry (IHC) and molecular tests, and is recommended as a reflex. Multiple tumors are related to Lynch syndrome including tumors of the stomach, small intestine, endometrium, ovary, genitourinary tract, sebaceous skin, and brain.
Douglas VanOort, NeoGenomics' Chairman and Chief Executive Officer, stated, "Entering the field of germline testing is a natural expansion for our company. By combining this type of testing with our extensive disease-specific cancer profiling, we believe that we are enabling physicians to practice better precision medicine."
Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented, "Considering the tremendous advances in genomics and the current availability of various genomic databases, inherited genomic variants should be considered as an integral part of the practice of precision medicine. The presence of a specific germline variant may influence selection of therapy as well as the long term management of the patient. The findings may also impact other members of the patient's family."
The current NeoGenomics offering includes individual gene testing of BRCA1, BRCA2, MLH1, MSH2, EPCAM, MSH6, PMS2 genes as well as a comprehensive 73 gene panel that includes the following genes: AKT1, APC, ATM, ATR, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, DKN2A, CEBPA, CHEK1, CHEK2, CTNNA1, EPCAM, ETV6, FAM175A, GALNT12, GATA2, GEN1, GREM1, HOXB13, KLLN, MEN1, MLH1, MRE11A, MSH2, MSH6, MUTYH, MYH1, MYH2, MYH3, MYH4, MYH6, MYH7, MYH8, MYH9, MYH10, MYH11, MYH13, MYH14, MYH15, NBN, NTRK1, PALB2, PIK3CA, PMS2, POLD1, POLE, PPM1D, PRSS1, PTEN, RAD50, RAD51, RAD51C, RAD51D, RET, RUNX1, SDHB, SDHC, SDHD, SMAD4, STK11, TERC, TERT, TP53, TP53BP1, VHL, WT1, XRCC2.
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