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.
The test, when used as intended, allows doctors to gauge the magnitude of benefit melanoma patients might derive from the immunotherapeutic Opdivo.
Holden Thorp is to be the new editor-in-chief of Science and its related journals.
A genetic analysis of salmon scales collected over the course of a century points to a sharp decline in the number of fish returning each year to river in British Columbia, CBC reports.
Adelaide University has suspended the head of an ancient DNA lab as its investigation of workplace bullying continues, Australia's ABC News reports.
In PNAS this week: gene expression profiles of adipocyte subtypes, computational approach for improving plant expressome analysis, and more.