In Combination with Carrier Screening, NIPS Provides Affordable, Streamlined Access to Genetic Testing for Parents-to-Be
Invitae Corporation (NYSE: NVTA), a leading genetics company, today announced the addition of non-invasive prenatal screening (NIPS) to the company’s comprehensive women’s health genetic testing services, providing patients with easier access to affordable genetic testing in early pregnancy. In combination with the expanded carrier screening (ECS), Invitae now offers integrated testing using the two most common prenatal genetic tests, with in-depth follow-up testing available for patients who need it. The company made the announcement in conjunction with the Society for Maternal-Fetal Medicine (SMFM) meeting in Las Vegas.
“NIPS is an important advance in prenatal screening. Historically, access to NIPS has been restricted to high-risk patients, but established criteria are imperfect predictors. With affordable NIPS now available, all women can benefit from having this information early in pregnancy,” said Robert Nussbaum, M.D., chief medical officer of Invitae. “Previously, non-invasive genetic screening in pregnancy was only available through measurement of maternal serum biomarkers and fetal ultrasound measurements. Now a single blood test can provide a better, more sensitive and more specific screen for the most common chromosomal imbalances.”
NIPS, sometimes called non-invasive prenatal testing (NIPT), analyzes small fragments of fetal DNA present in the mother’s bloodstream during pregnancy. NIPS is used to screen pregnancies for chromosomal abnormalities as early as 10 weeks gestation and is also the earliest test that can predict the sex of the baby, if desired. In combination with carrier screening, these screens provide detailed genetic health information without the need for invasive procedures such as chorionic villus sampling (CVS) or amniocentesis. If a patient’s NIPS results show an elevated risk of a chromosomal imbalance condition, the company’s follow-up prenatal diagnostic testing can provide a definitive result.
Invitae’s advanced NIPS quickly analyzes cell-free DNA to assess whether a pregnancy (singleton or twin) is at increased risk for the three most common chromosomal disorders, including Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome) and Trisomy 13 (Patau syndrome). Microdeletion and sex chromosome analysis can be added at no additional charge.
The company will begin accepting orders for NIPS testing next week.
Invitae is combining its new NIPS offering with the Invitae Carrier Screen in one specimen collection kit. Invitae’s comprehensive carrier screen uses advanced sequencing to identify changes in 301 genes linked to serious genetic disorders, including cystic fibrosis (CF), spinal muscular atrophy (SMA) and many other life-threatening disorders. The American College of Obstetrics and Gynecologists recommend offering carrier screening to all patients of reproductive age, including pregnant patients at any level of risk.
NIPS is the latest addition to Invitae’s women’s health test menu, which delivers medically actionable insights for women through all stages of their lives. From proactive testing to assess genetic risk factors for cancer and cardiovascular disease, to prenatal testing before and during pregnancy, to diagnostic testing for women with breast, ovarian and other cancers, Invitae provides comprehensive, clinical-grade genetic information to guide women’s health decisions.
Invitae Corporation (NYSE: NVTA) is a leading genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at 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 benefits and features of the company’s NIPS, expanded carrier screen and other testing; and when the company will begin accepting orders for NIPS testing. 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 history of losses; the company's ability to compete; the company's failure to manage growth effectively; 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 September 30, 2018. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.