SILICON VALLEY, Calif., July 25, 2022 (GLOBE NEWSWIRE) — Predicine, a global molecular insights company committed to advancing precision medicine in oncology and infectious diseases, announced today a nationwide expansion of its COVID-19 testing solution through the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of Predicine’s SARS-CoV-2 RT-PCR test and self-collection kit. This FDA EUA enables Predicine to provide more testing service to broader community population across the nation.
Predicine’s SARS-CoV-2 RT-PCR is a DNA extraction free method with matrix sample collection tubes that delivers a highly accurate result in less than 6 hours following the receipt of a sample, the shortest possible turnaround time. The self-collection of samples will enable Predicine to expand its mass covid testing and increase community service. Predicine also plays a critical role in detecting the variants of SARS-CoV-2, including the Omicron variant (B.1.1.529) and the sub-variants, such as the BA.2 or stealth omicron, BA.4 and BA.5 which are considered more contagious than all previous sub-variants.
This test is FDA-authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal specimens collected from any individual, including individuals without symptoms. Predicine’s COVID-19 test kit is for use with anterior nasal swab specimen collected at home (which includes in a community-based setting) from: individuals aged 18 years and older (self-collected), 14 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance), when determined to be appropriate by a healthcare provider.
Predicine has five CLIA certified laboratories in its nationwide network including two in Silicon Valley and new laboratories in Chicago, Houston, and Los Angeles. Currently, Predicine works with a network of public health and private entities to provide increased access to testing. The current FDA EUA authorization further enables Predicine’s nationwide effort in providing affordable and accessible molecular testing solution in infectious diseases and oncology.
“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,” said Shidong Jia, Founder & CEO of Predicine.
Predicine is a global molecular insights company committed to advancing precision medicine in oncology and infectious diseases. Predicine is developing proprietary cell-free DNA- and cell-free RNA-based liquid biopsy technologies to enable minimally invasive molecular diagnosis for early cancer detection, treatment selection, therapy response, minimal residual disease monitoring and disease progression. The Predicine portfolio includes blood-, urine-, and tissue-based NGS assays designed for global harmonized use in research, clinical investigation, and CDx development. Predicine has applied its quality, expertise, credibility, and innovation to COVID-19 testing during a world-wide pandemic. By offering customized, comprehensive COVID-19 testing solutions, Predicine empowers school districts, municipalities, businesses, and other communities in confronting COVID-19. Through its business operations in Silicon Valley, Houston, Chicago, Los Angeles, Boston, Shanghai, Singapore, Beijing, Suzhou, and Harbin, Predicine is partnering and collaborating with leading biopharma companies, institutions, and governments to support personalized healthcare on a global scale. Further information is available at http://www.predicine.com. Stay in touch on LinkedIn or @Predicine on Twitter. Reach out to us at [email protected]