Invitae Expands Reproductive Health Offering with Launch of Comprehensive Genetic Carrier Screening

-- New Testing Provides Affordable, Accessible Information for Parents-to-Be --

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Jun 25, 2018, 07:30 ET

SAN FRANCISCO, June 25, 2018 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), one of the fastest growing genetics companies, today announced the launch of the Invitae Carrier Screen, a comprehensive test designed to provide affordable, accessible information on genetic changes that pose a risk for parents of having a child with an inherited genetic disorder. Each year 7.8 million children worldwide are born with health problems caused at least in part by genetics¹.

Invitae genetic testing when starting a family

Invitae's comprehensive genetic carrier screen

"By providing affordable, comprehensive, high-quality genetic information, Invitae carrier testing can help parents-to-be have the information they need to make appropriate health decisions when starting a family," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Most often, people who are carriers of potentially serious alterations in a gene are unaware of their status and have no symptoms, known as 'silent carriers.' Carrier screening provides information about the risks of unknowingly passing along a genetic disorder from one or both parents to a child, which is why professional societies, such as the American College of Medical Genetics and Genomics and the American College of Obstetrics and Gynecology, recommend carrier screening for all people considering pregnancy."

The Invitae Comprehensive Carrier Screen uses next-generation sequencing to identify changes in 287 genes linked to serious genetic disorders, including cystic fibrosis (CF), spinal muscular atrophy (SMA) and many other life-threatening disorders. The test identifies the vast majority (>99%) of disease-causing changes in most of the genes analyzed, compared to more limited approaches that test for only changes in genes most commonly seen in particular ethnic groups. Invitae's test is appropriate for people of all ethnicities who want a comprehensive assessment of their risk of having a child with a serious inherited genetic disorder.

"We're building the industry's most comprehensive and affordable reproductive health offering, using our world-class expertise to increase access to genetic information when having a family," said Sean George, co-founder and chief executive officer of Invitae. "As we continue toward our goal to aggregate the world's genetic tests into a single service, the addition of carrier screening further strengthens our ability to provide genetic information to inform healthcare decisions through every stage of life."

The panel includes screening for:

All disorders recommended by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG)
An extended list of disorders recommended by national Jewish societies
Disorders that may have a severe presentation
A selection of disorders found on the newborn screen
Several X-linked disorders, including Fragile X syndrome

Beyond the 287-gene panel, Invitae also offers two additional pre-curated panels: a 46-gene test assessing a smaller set of common disorders and a targeted test consisting of the three genes associated with CF, SMA and Fragile X syndrome. These smaller panels can be supplemented with a customized set of additional genes from the larger 287-gene panel based on a person's specific needs. There are also an additional 13 genes not included in a pre-curated panel that can be added to any test.

Turnaround times average 14 days, and testing is covered by most major insurers. Patients with insurance can elect to receive a personalized cost estimate based on their insurance coverage. For patients who do not go through insurance, any Invitae carrier screen, regardless of the number of genes, can be ordered for $250 with patient-pay. A reproductive partner discount is available for $100. Access to board-certified genetic counselors is available during the testing process for patients and clinicians as part of the service.

The Invitae Carrier Screen replaces the existing GeneVu carrier screen previously ordered through Good Start Genetics, which was acquired by Invitae in 2017. The test extends the company's reproductive health testing services, which include preimplantation genetic screening (PGS), miscarriage analysis, pre-natal and neonatal testing.

About Invitae
Invitae Corporation (NYSE: NVTA) is a genetics company whose 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 prices.

Safe Harbor Statement
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 the company's new carrier screen test, including helping parents-to-be have the information they need to make appropriate health decisions when starting a family; the specifications of the new carrier screen test, including average turnaround time; and that the new expanded carrier screening service makes the company uniquely able to provide genetic information to inform healthcare decisions through every stage of life. 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 company's ability to develop and commercialize new tests and expand into new markets; the company's ability to compete; the company's history of losses; the company's failure to manage growth effectively; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; 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 March 31, 2018. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Contact:
Laura D'Angelo
[email protected]
(628) 213-3283