CLN Article

Regulatory Roundup

FDA Clears First Test That Can Detect CRE Directly From Clinical Specimens

The Food and Drug Administration (FDA) has cleared the Xpert Carba-R, a new assay from Cepheid that is designed to help control infections resulting from Carbapenem-resistant Enterobacteriaceae (CRE) by detecting specific genetic markers associated with CRE. To identify colonization with CRE, current methods rely on growing bacteria from fecal material in cultures, which are then subjected to antimicrobial susceptibility testing. This process can take up to 4 days to produce a result, and often requires additional testing to confirm the presence of carbapenemase, the enzyme produced by CRE. In contrast, the Xpert Carba-R is the first assay that enables labs to test rectal swab specimens from patients directly for five different genetic markers that are associated with carbapenemase. FDA’s decision to clear the test was based on data from two clinical studies that found that Cepheid’s assay performs on par with traditional culture methods.

While the Xpert Carba-R can detect the most prevalent carbapenemase genes associated with antibiotic resistance, it cannot detect all types of carbapenemase genes or bacteria, carbapenemase activity, or other non-enzymatic causes of carbapenem resistance. FDA therefore recommends that labs continue to perform standard bacterial cultures in conjunction with the Xpert Carba-R to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and confirmatory bacterial identification.

FDA Issues Draft Guidance on NGS Tests

The Food and Drug Administration (FDA) has issued two draft guidances that, when finalized, aim to provide a flexible and streamlined approach to the oversight of next-generation sequencing (NGS)–based tests. The first draft guidance, “Use of Standards in FDA’s Regulatory Oversight of Next Generation Sequencing (NGS)–Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases,” provides recommendations for designing, developing, and validating NGS-based tests for rare hereditary diseases. The second draft guidance, “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)–Based In Vitro Diagnostics,” explains how test developers can use data from FDA-recognized public genomic databases to support clinical claims in marketing submissions.

Electronic feedback on both draft guidances can be submitted at through September 6. 

FDA Oks Roche HPV Test

The Food and Drug Administration (FDA) has approved the Roche cobas HPV test as the first test for human papillomavirus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath preservative fluid. In 2012, the manufacturer of SurePath warned laboratories that using cervical cell samples in SurePath preservative fluid to run HPV tests could lead to false negative results. The Roche cobas HPV test now provides specific instructions for labs to process cervical samples collected in SurePath preservative fluid to minimize this risk.