FDA granted De Novo marketing authorization to Vela Diagnostics' test for detecting HIV Type-1 drug resistance mutations, the agency said Tuesday.
The authorization marks the first time the FDA has cleared an assay for use in the U.S. that uses next-generation sequencing (NGS) to test for HIV drug-resistant mutations.
Equipped with the test, the FDA said physicians could gather the information they need to tailor antiviral treatments to the individual patients' genetics.
Antiviral therapy has turned HIV into a chronic disease but the emergence of drug-resistant strains threatens to undermine progress made to date. Since the global rollout of antiretroviral therapy began in 2001, the prevalence of resistance has increased jumped from 11% to 29%. Double-digit drug resistance rates are seen in pretreated patients in many countries.
Physicians currently gauge whether a patient is resistant to regular treatment by monitoring their viral load. If levels of the virus increase, the patient may develop resistance to medicine.
The FDA-authorized assay this week gives physicians a different way to assess resistance. The NGS test detects 342 HIV drug resistance mutations in blood samples. Physicians can use the information to choose combinations of medicines to which the virus remains susceptible.
"The ability to rationally select treatments for patients starting or already taking antiviral therapy provides another tool in our ongoing fight against HIV," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "The right combination of antivirals can lower viral loads, or the amount of virus in the blood stream, and help keep HIV patients healthy for many years."
Fairfield, New Jersey-based Vela Diagnostics secured FDA authorization on data strength assay detecting 342 drug resistance mutations with sensitivity and specificity in excess of 95%. The product label Vela also evaluated the reproducibility of the test results by analyzing the same samples at different sites.
The data persuaded the FDA to authorize the assay through its De Novo pathway and categorize it as a Class II device. FDA identified inaccurate detection of mutations and incorrect interpretation of results as the main risks associated with the test. The agency said labeling information and validation procedures are likely to mitigate these risks.
According to Vela, an earlier version of the product received a CE mark in 2017 and has been approved by regulatory bodies in Australia, Singapore and Thailand. The company said the most recent version of the assay is currently being reviewed by regulators in Europe and Singapore.