While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
Originally developed by Thermo Fisher Scientific, the test is modified for use on additional specimen types, including saliva, as well as with alternative nucleic acid extraction and amplification systems.
The FDA has also granted emergency use authorization for PCR-based tests for SARS-CoV-2 developed by Orig3n, Specialty Diagnostic Laboratories (SDI), and the University of North Carolina (UNC) Medical Center.
The test is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal and oropharyngeal swab specimens from individuals suspected of having COVID-19.
The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.
Thermo Fisher plans to use the proceeds to pay in part for the acquisition of Qiagen, expected to close in the first half of 2021, and for general corporate purposes.