The EUA authorisation will allow the firm to expand its testing capabilities to provide more testing services to the broader community population across the nation
Predicine receives FDA EUA for SARS-CoV-2 RT-PCR test and self-collection kit. (Credit: fernando zhiminaicela from Pixabay)
Molecular insights company Predicine has received the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its SARS-CoV-2 RT-PCR test and self-collection kit.
The EUA authorisation will allow the firm to expand its testing capabilities to provide more testing services to the broader community population across the country.
Predicine’s test is a DNA extraction method that uses matrix sample collecting tubes to produce a highly accurate result in the shortest turnaround time of less than six hours after receiving a sample.
The firm will be able to increase community services and its mass Covid testing due to its method of self-collection of samples.
Predicine said that it is essential to identify SARS-CoV-2 variations, including the Omicron variant (B.1.1.529) and sub-variants such as the stealth omicron (BA.2), BA.4, and BA.5.
The FDA has approved the test for the qualitative identification of SARS-CoV-2 nucleic acid in anterior nasal specimens taken from any person, including those who are asymptomatic.
The test kit is for use with anterior nasal swab specimens taken at home from people who are: 18 years of age or older (self-collected); 14 years of age or older (self-collected under adult supervision); or two years of age or older (collected with adult assistance).
Predicine founder and CEO Shidong Jia said: “Obtaining FDA EUA approval for Predicine’s Covid-19 PCR test and at-home collection kit is a significant milestone that aligns with Predicine’s strategic focus to execute new product development in oncology and infectious disease.
“This approval is timely during another COVID-19 surge nationwide. This furthers the national effort to control the spread of the virus and protect the community and general public.”
The company has five CLIA-certified laboratories, including two in Silicon Valley and brand-new facilities in Chicago, Houston, and Los Angeles.
The current FDA EUA authorisation supports Predicine’s efforts to offer accessible and cheap molecular testing solutions for infectious illnesses and cancer across the country.