The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.
Combining the two companies would allow patients to access genetic testing and their health records in one place, and make it easier for Invitae to collect and organize health records.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
ArcherDX had filed with the SEC earlier this month for a $100 million initial public offering. The two companies said combining would enable cancer patients to access a variety of testing products and services from one source.
The market for reproductive genetic testing historically been dominated by carrier screening but progress is being made in different methods, including non-invasive prenatal testing.
“We’re building a company for the coming genomic era that includes genetic capabilities through all phases of life,” said Invitae CEO Sean George in a phone interview.
Several fundamentals have changed to accelerate growth in the genomics space, spurring our second look into the sector.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Sean George believes that the genetic testing market will see consolidation and those that survive will provide low-cost high value tests to a wide swathe of the population.
Invitae's proposition with these new panels is to democratize the genetic panel screen - testing for deeply impactful disorders that stretch beyond cancer.
Gene diagnostics megaplayer Invitae has raised a whopping $120 million in a Series F round – proof positive that startups operating in the vein of 23andMe are able to attract large swaths of cash. The company has a single diagnostic test that tests 200 genes for a variety of genetic disorders associated with cancer, cardiology, neurology and […]