RESEARCH TRIANGLE PARK – Invitae, a California-based medical genetics company that will soon open a new laboratory and production facility in Morrisville, has commercially launched a new testing package for neurodevelopmental disorders (NDDs) in children.

Invitae is the first to offer such tests to clinicians and patients in an easily accessible format, the company said in a news release.

“The NDD package provides genetic answers in a timely fashion, with a goal of informing physicians and parents, informing care decisions and developing appropriate treatment plans for patients,” said Robert Nussbaum, M.D., chief medical officer of Invitae. “Although numerous other labs offer each individual component, Invitae is the only lab to offer this as a comprehensive suite of tests with rapid turn-around time of 10 to 21 days.”

The NDD buccal test kit. (Invitae photo)

The package includes chromosomal microarray analysis, analysis for fragile X-related disorders, and a next-generation-sequencing panel of 200-plus genes in which variants are associated with neurodevelopmental disorders. The gene panel can detect sequence variants as well as full or partial gene deletions and duplications that a chromosomal microarray analysis alone may not detect.

The test package, accessible through one sample collection kit, provides reports that can help clarify the genetic etiology and root cause of NDDs, which are complex and sometimes have overlapping conditions.

One in six children between the ages of 3 and 17 years old has a developmental disability, yet two out of three children don’t receive the recommended genetic testing, according to Invitae.

The NDD tests are supported by guidelines from the American Academy of Pediatrics that recommend CMA and fragile X syndrome testing for children with intellectual disability, global developmental delay or autism spectrum disorder. The guidelines also recommend further testing that may include gene panels and whole-exome sequencing.

About 350 jobs for Morrisville

Invitae, a publicly held company headquartered in San Francisco, announced a year ago that it would invest $114.6 million in a new laboratory and production facility in Morrisville to further expand its capacity to meet a growing demand for genetic testing services globally.

Invitae’s Morrisville site.

The 250,000-quare-foot laboratory and production facility is expected to eventually employ more than 350 people.

The company told NCBiotech it has received a temporary certificate of occupancy for the facility and plans to acquire equipment and begin hiring key staff this year. Lab processing of tests is expected to begin in the third quarter of 2023.

The facility is in the rezoned and renovated 25-acre site of the former Morrisville Outlet Mall on Airport Boulevard, renamed The Stitch.

Invitae, founded in 2010, says it has about 3,000 employees globally and has laboratory production facilities in California, Colorado and Washington.

The company has provided medical genetics information to more than 2.5 million people. It projects to earn $640 million in 2022, about 40% more than the $460 million it reported last year.

(C) N.C. Biotech Center