NEW YORK — Biodesix said on Friday that it has partnered with Bio-Rad Laboratories to gain US Food and Drug Administration Emergency Use Authorization for a droplet digital PCR (ddPCR) test for SARS-CoV-2.
According to Hercules, California-based Bio-Rad, two recent Chinese studies have shown that its QX200 ddPCR system offered better sensitivity and precision for SARS-CoV-2 detection than existing qPCR methods. One study indicated that ddPCR testing can reduce false negative results without increasing false positives. The other showed that ddPCR improved diagnostic detection accuracy of SARS-CoV-2 from 28.2 percent to 87.4 percent, and that ddPCR was effective for low virus load specimens from patients under isolation and observation even without any clinical symptoms.
Neither study has yet been peer reviewed, Bio-Rad noted.
Boulder, Colorado-based Biodesix, which focuses on ddPCR-based tests for lung diseases, said it will begin offering the test once it receives EUA from the FDA.