SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE: NVTA), a genetic information company, today announced that it has entered into a collaboration with the Sudden Death in the Young (SDY) Case Registry, the first ever active surveillance effort designed to increase understanding of the prevalence, causes and risk factors for sudden death in the young. The Registry is funded by the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS), and the Centers for Disease Control and Prevention (CDC); the Data Coordinating Center is at the Michigan Public Health Institute (MPHI); and the SDY Biorepository is at the University of Michigan (UM). Invitae is providing comprehensive diagnostic arrhythmia genetic testing to the Registry on autopsy negative cases as in-kind services in collaboration with MPHI and UM.
The SDY Case Registry creates a surveillance system to identify cases of sudden death in the young, defined as up to age 20. Cases may include sudden cardiac death, sudden unexpected death in epilepsy (SUDEP), and sudden unexpected infant death (SUID) as well as others. Through MPHI, local medical examiners and review teams submit information and samples for DNA on cases. The Registry is being administered in 10 areas of the country, including the city of San Francisco, Delaware, Georgia, Minnesota, Nevada, New Hampshire, New Jersey, Tennessee, the Tidewater Region of Virginia, and ten selected counties in Wisconsin.
“Working on the SDY Case Registry will allow for the most clinically relevant and actionable information to be provided back to participating families. If a genetic diagnosis is made, the relatives of these individuals are at high risk, up to 50%, of also carrying the genetic alteration, so early diagnosis is key to allow for evaluation and intervention before the patient’s relative also presents with sudden death,” said Robert Nussbaum, MD, chief medical officer of Invitae and an attending physician in the Cardiovascular Genetics Clinic at UCSF. “The SDY Case Registry is an opportunity to collaborate with medical examiners to determine how many cases of unexplained sudden death are due to a genetic, cardiovascular disorder and to explore best practices of integrating genetic testing into routine autopsy practice to assist in determining cause of death.”
Through this collaboration, the local medical examiner will now be able to order an Invitae comprehensive arrhythmia test in autopsy negative cases where the cause of death can't be determined and consent for diagnostic genetic testing is obtained by grantees in accordance with MPHI and state local institutional review boards. Invitae has agreed to provide diagnostic genetic testing services for 900 autopsy negative SDY Registry cases over a three-year period.
"We are thrilled to partner with Invitae on providing genetic testing to the SDY cases that are autopsy negative. We have heard from the medical examiner community throughout this project that this is an important tool that they need to better investigate these deaths, and this innovative private/public partnership will help meet that need,” said Theresa M. Covington, MPH, Director of the National Center for the Review and Prevention of Child Deaths as well as the SDY Data Coordinating Center. “Invitae's generous donation is a major contribution to the Registry and the families that it serves."
Invitae recently announced that it has expanded its cardiology test menu to include more than 30 test panels, representing more than 190 carefully curated genes. Expanded test panels include tests for genes highly relevant to diagnosing an underlying cause of autopsy negative sudden death in the young, such as various types of genetic arrhythmias, as well as panels for other forms of cardiovascular disease including cardiomyopathies, aortopathies, familial hypercholesterolemia, pulmonary hypertension, and congenital heart disease.
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 single diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics and other rare disease areas.
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 potential benefits of this genetic testing to clinicians and relatives of the victims of SDY, and the ability of the company to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. 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 results to affect treatment decisions; risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.