NEW YORK – Meridian Bioscience said on Wednesday that it has received approximately $1 million in funding from the National Institute of Health's Rapid Acceleration of Diagnostics program to expedite the launch of its SARS-CoV-2 PCR test.
The company said it submitted the Revogene SARS-CoV-2 test to the US Food and Drug Administration for Emergency Use Authorization earlier this month. The RT-PCR test qualitatively detects SARS-CoV-2 nucleic acid in nasopharyngeal swab specimens and can provide results within 47 minutes for positive samples. According to Meridian's product brochure, the positive agreement is nearly 93 percent and the negative agreement is 99 percent.
NIH funds were also used to develop the molecular diagnostic test, which detects RNA targets directly from viral transport media without pre-dilution in the sample workflow. The firm had to create a new assay formulation to "optimize the microfluidic properties of our PIE assay device," and to "enable new enzymology and internal processing controls." NIH's RADx program also gave the company access to consultants and external clinical testing.
"The NIH contribution to our SARS-CoV-2 assay was instrumental in our goal achievement, providing a kick-start to meet our product development milestones and helping us create a new generation PIE device for the detection of respiratory viral targets directly from unprocessed specimens," said Lawrence Mertz, the firm's senior VP of diagnostics research and clinical development. "We are now using this innovation to expand our respiratory viral menu on the Revogeneplatform."
CEO Jack Kenny said on a recent conference call to discuss the company's fourth quarter earnings that Meridian has also adapted its in-development Revogene respiratory panel to include SARS-CoV-2.