The company plans to submit its 650- to 700-gene panel, which will include microsatellite instability testing, to the FDA for approval as a companion diagnostic.
Researchers profiled cancer gene mutations, expression, protein patterns, and other features in 23 recurrent or metastatic cases of olfactory neuroblastoma.
The companies will perform tumor profiling to identify patients with genetic abnormalities that could make them eligible for treatment in the NCI study.
There are now 100 sites in the US participating in the basket study, and soon trials with similar approaches will be available in Canada and 13 other countries.
Though considered potential antibody alternatives, these reagents are more likely to succeed in new applications for which conventional tools are poorly suited.
There was a lot of growth in the precision medicine field in the past year, and some experts believe the FDA's decision to hold off on regulating LDTs could spur more innovation.
Lawmakers have asked four direct-to-consumer genetic testing companies to explain their privacy policies and security measures, according to Stat News.
