FDA Watch: Next-Gen Sequencing Companion Test Wins Approval

Last month, the U.S. Food and Drug Administration shelved its longawaited/ dreaded (depending on your point of view) final guidance on laboratory-developed tests. (For the details, see, LIR, Nov. 2016). This month, it was back to business as usual—although a piece of significant new legislation will have a lasting impact on the FDA in the long-term.

New FDA Approvals
Arguably, the most noteworthy FDA Section 510(k) approval of the month was 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

New Applications
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 IFVRSV 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.

21st Century Cures Act Draws New Lines on FDA Authority
The month’s most significant FDA development in the long-term was the passage of the new 21st Century Cures Act legislation which imposes new rules on FDA oversight of drugs, devices and biologics. Key items:

  • New language "clarifying" that the FDA is not responsible for regulating health care software targeting health care facility administrators or functions, e.g., software for transferring lab data;
  • Similar clarification that the FDA lacks responsibility for regulating consumer-facing applications, including but not limited to apps for "maintaining and encouraging a healthy lifestyle";
  • New approval pathway allowing for smaller and faster clinical trials for antibacterial drugs that treat infections resistant to existing treatments; and
  • $500 million in funding for new administrative and enforcement activities—although Congress must adopt actual legislation to appropriate that money.

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