Company offers multi-gene panels based on NCCN guidelines to help clinicians select tests for their individual patients
Invitae Corporation (NYSE: NVTA), a genetic information company, presented data on its guidelines-based genetic testing panels at the NCCN Annual Conference: Advancing the Standard of Cancer Care in Hollywood, Florida, on Thursday. Invitae offers guidelines-based panel testing that clinicians can customize to reflect their own diagnoses and expertise to ensure that clinicians have the right tests for the right patients.
"We have entered an era where testing for BRCA1 and BRCA2 alone is inadequate,” said Peter Beitsch, MD, FACS, surgical oncologist, Director of the Dallas Breast Center, and past president of the American Society of Breast Surgeons (ASBS). “Inherited pathogenic mutations in many other genes lead to breast (and other) cancers and these genes should also be evaluated in patients who qualify for traditional BRCA1/2 testing. This speaks to the importance of a properly vetted list of actionable genes tested by a lab with proven quality.”
Invitae presented two studies:
Clinical actionability of panel testing for genes in the 2.2016 NCCN guidelines for hereditary breast and ovarian cancer (HBOC)
The NCCN guidelines for patient care now describe multi-gene testing for inherited risks for a number of different cancers. Building off the company’s study with Massachusetts General Hospital, Stanford University, and Beth Israel Deaconess Medical Center published in JAMA Oncology in 2015, the authors considered the actionability of specific genes included in the latest versions of the NCCN guidelines. Consistent with the publication, most non-BRCA1/2 mutations seen in a clinically representative population would warrant consideration of a change in care for both the patient and also any mutation-positive family members identified through additional testing. Based on Invitae’s diagnostic practice to date, about 50% more patients would be expected to have an actionable inherited mutation uncovered by a guidelines-based panel test, compared to BRCA1/2 testing alone.
Clinical presentations of 111 patients with germline PALB2 mutations: Looking beyond breast and ovarian cancer
PALB2 is a gene recently added to the NCCN guidelines and which is known to confer a variable level of lifetime cancer risk, depending on clinical factors. The study authors examined personal and family cancer histories for 111 sequential PALB2 carriers identified through Invitae’s clinical testing practice. A diversity of cancers was observed in these patients and their family members, including many early-onset cases. A significant group of patients presented with multiple primary tumors, including prostate, colorectal, thyroid, endometrial, papillary urothelial, gastric, melanoma, and urinary tract cancers. These data are consistent with PALB2 conferring a high and heterogeneous cancer risk in those patients who are typically referred for genetic testing under current guidelines.
“The NCCN guidelines recognize that panel testing, compared to the traditional testing approach, is more cost-effective and can improve care by including important, additional findings that inform prognosis and management of patients,” said Robert Nussbaum, MD, chief medical officer of Invitae. “Invitae provides comprehensive and affordable high-quality clinical genetic tests in a medically responsible way, supporting the implementation of clinical guidelines and ensuring our guidelines-based panels incorporate the most up-to-date NCCN recommendations.”
Both Invitae abstracts were selected for publication in the May special issue of Journal of the National Comprehensive Cancer Network (JNCCN): Highlights of the Annual Conference.
Invitae Corporation's (NYSE: NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitae’s goal is to aggregate most of the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower price than many single-gene and panel tests today. The company currently provides a diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics and other rare disease areas. For more information, visit our website at ir.invitae.com.
Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the utility of multi-gene panel testing, including that it is more cost-effective, can improve patient care, and that more patients would be expected to have an actionable inherited mutation uncovered by a guidelines-based test, compared to BRCA1/2 testing alone. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the ability of clinical study results to affect treatment decisions; the company’s ability to generate substantial demand for its tests; the company’s ability to develop and commercialize new tests and expand into new markets; risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; the company’s ability to compete; laws and regulations applicable to the company’s business, including potential regulation by the Food and Drug Administration; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.
Source: Invitae Corporation