FDA Watch: New FDA Approvals & Applications in Diagnostics
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine’s FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA approved the test for use in identifying advanced ovarian cancer patients with BRCA mutations. Not coincidentally, the agency has or shortly will approve pharmaceutical products for treating ovarian cancer […]
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA approved the test for use in identifying advanced ovarian cancer patients with BRCA mutations. Not coincidentally, the agency has or shortly will approve pharmaceutical products for treating ovarian cancer patients with the gene mutations detected by CDxBRCA, including Clovis Oncology's PARP inhibitor Rubraca.
At least three other diagnostics products received Section 510(k) clearance from the FDA in December, including:
| Manufacturer(s) | Product(s) |
| Statlife | DenSeeMammo breast density assessment software based on BI-RADS guidelines that can be used in combination with Statlife's MammoRisk risk assessment tool |
| Animas Corporation (a subsidiary of Johnson & Johnson) | One Touch Vibe Plus insulin pump and continuous glucose monitoring system |
| Cepheid | Xpert MRSA NxG test for MRSA (methicillin-resistant Staphylococcus aureus) infection |
Companies that submitted new 510(k) clearance applications during the month include:
- Biocartis for its Idylla molecular diagnostics platform
- Biocartis and Janssen Diagnostics for Janssen Idylla Respiratory IFV-RSV Panel for detecting influenza and respiratory syncytial virus using the Idylla platform
- GenMark Diagnostics for ePlex, a respiratory pathogen panel based on the company's eSensor electrochemical detection technology
- Great Basin Scientific for its molecular panel assay for stool pathogens.