Skip to main content
Premium Trial:

Request an Annual Quote

HiFi DNA Sues FDA for Dragging Feet on Reclassifying HPV Dx

NEW YORK (GenomeWeb News) — HiFi DNA Tech said today that it filed a lawsuit against the US Food and Drug Administration last week for allegedly failing to respond in time to the company’s petition to reclassify DNA tests for human papillomavirus from class III to class II devices.   
 
The Trumbull, Conn.-based company, which makes reagents and has developed a PCR-based HPV genotyping methodology, said the agency is required to either approve or deny such petitions within 210 days under the Federal Food, Drug and Cosmetic Act. The company filed its petition to reclassify the test in May.
 
The agency's "inaction" blocks the availability of newly developed molecular diagnostic tests and may be hindering women from accessing treatment and slowing therapeutic decision-making, President Sin Hang Lee said in a statement.
 
“Reclassification of HPV tests as class II in vitro devices will encourage small innovative companies to use the less burdensome 510k applications to introduce their new technologies for more accurate HPV testing on a competitive basis," Lee added.
 
The FDA did not immediately return a telephone call seeking comment.

The Scan

Study Finds Sorghum Genetic Loci Influencing Composition, Function of Human Gut Microbes

Focusing on microbes found in the human gut microbiome, researchers in Nature Communications identified 10 sorghum loci that appear to influence the microbial taxa or microbial metabolite features.

Treatment Costs May Not Coincide With R&D Investment, Study Suggests

Researchers in JAMA Network Open did not find an association between ultimate treatment costs and investments in a drug when they analyzed available data on 60 approved drugs.

Sleep-Related Variants Show Low Penetrance in Large Population Analysis

A limited number of variants had documented sleep effects in an investigation in PLOS Genetics of 10 genes with reported sleep ties in nearly 192,000 participants in four population studies.

Researchers Develop Polygenic Risk Scores for Dozens of Disease-Related Exposures

With genetic data from two large population cohorts and summary statistics from prior genome-wide association studies, researchers came up with 27 exposure polygenic risk scores in the American Journal of Human Genetics.