The latest move will allow the company to expand its Covid-19 testing capability across the country to a broad community population.
The SARS-CoV-2 RT-PCR Test is designed to detect nucleic acid in anterior nasal samples that are collected from individuals with or without Covid-19 symptoms.
It is a DNA extraction-free process with matrix sample collection tubes that provide accurate results in less than six hours from receiving a sample.
With sample self-collection, the company will be able to expand its mass testing for Covid-19.
The test kit has also been developed to use anterior nasal swab samples self-collected at home under adult supervision for those aged 14 years and above, and collected with the assistance of adults for individuals aged two years and above.
Predicine founder and CEO Shidong Jia said: “Obtaining F DA 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 stated that it has five CLIA-certified laboratories across the US, which include two in Silicon Valley, as well as new labs in Los Angeles, Houston and Chicago.
It is currently working with public health networks and private entities to provide increased access to Covid-19 testing.
The latest regulatory approval supports the company’s efforts to provide accessible and affordable molecular testing solutions for infectious diseases and oncology.