The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Almac is developing the assay to enroll patients for clinical trials used to develop repotrectinib, an investigational tyrosine kinase inhibitor.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.
Investigators will use Biocept's liquid biopsy tests to detect ALK rearrangements both at baseline and to monitor treatment response and resistance mechanisms.
The IHC test was used in clinical studies that led to Zykadia's approval last week as a first-line option for metastatic NSCLC patients with ALK rearrangements.
The expanded indication makes it a first-line option for metastatic non-small cell lung cancer patients with ALK rearrangements.
A big bump in service revenues made up for a decline in product revenues. The company also trimmed its operating expenses and narrowed its net loss.
The assay can be used to identify patients suitable for treatment with ALK-targeted therapeutics such as Pfizer's Xalkori.