The test can now be used to detect EGFR mutations in tissue and blood for lung cancer patients considering treatment with the tyrosine kinase inhibiting drugs Tarceva and Tagrisso.
The company said it is confident it can address the state health department's concerns and will reapply for approval as soon as possible.
The diagnostic, a real-time PCR kit for breast cancer stratification, is being reviewed under a special process for the approval of innovative products.
The NGS-based assays will be implemented at Memorial Sloan Kettering Cancer Center alongside targeted DNA sequencing assays to identify gene fusions.
The test, EXaCT-1, may not only help doctors find treatments for patients who have run out of options but may also provide biomarkers of immunotherapy response.
The test may help identify patients most likely to respond to Roche's new metastatic urothelial cancer drug Tecentriq, the FDA said.
The companion test will let doctors identify the best treatment for CLL patients with 17p deletions, a subset that has historically lacked therapeutic options.
The test, which was previously approved for CLL prognosis, is now cleared for use in identifying patients who may benefit from AbbVie and Genentech's Venclexta.
The approval comes after the FDA twice asked the company to provide additional data around the test's ability to boost screening compliance.
By showing flexibility and requiring a CDx in the post-market setting, the agency hopes to encourage the development of a universal NGS test.
In PLOS this week: preconception carrier screening program results, comparative genomics-based analysis of Elizabethkingia meningoseptica, and more.
Canadian regulators are beginning to share information from new drug studies, Undark reports.
In a column at the Dallas Morning News, the Stanley Medical Research Institute's E. Fuller Torrey says the Human Genome Project hasn't delivered on promised results.
Researchers explore a possible genetic cause for some cases of sudden infant death syndrome, KOMO News reports.