NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Tempus and Alimetrix.
Tempus' iC SARS-CoV-2 test is designed to detect the N, S, and ORF1ab genes of the virus in upper respiratory tract specimens. It is a version of Thermo Fisher Scientific's authorized Applied Biosystems TaqPath COVID-19 Combo Kit that has been modified for use with specimens collected in Mawi DNA Technologies' iSWAB-Microbiome collection tubes or viral transport medium.
RNA extraction is performed using Perkin Elmer's Chemagic Viral DNA/RNA 300 H96 kit and Chemagic 360 instrument, and the test runs on Thermo Fisher's Applied Biosystem QuantStudio 7 Flex RT-PCR System.
The test may only be performed at Tempus' CLIA labs in Chicago and Peachtree Corners, Georgia, according to the FDA authorization.
The EUA comes after Tempus, based in Chicago, said in May that it was expanding its business into infectious disease, starting with COVID-19 diagnostic testing.
In March, Tempus raised $100 million in Series G funding, which the precision medicine company said it will use to expand beyond its initial focus on cancer to include diabetes, depression, and cardiology.
The Alimetrix SARS-CoV-2 RT-PCR Assay with microarray detection is designed to detect the virus' N and ORF1ab genes in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swab specimens, as well as nasopharyngeal washes/aspirates or nasal aspirates and bronchoalveolar lavage specimens.
RNA extraction is performed using either Zymo Research's Quick-DNA/RNA Viral MagBead Extraction Kit and MagMax Express 96 instrument or Qiagen's QIAamp 96 Virus QIAcube HT kit. The test uses Thermo Fisher's Applied Biosystems GeneAmp 9700 Thermal Cycler for amplification and Sensovation's SensoSpot microarray scanner with ArrayReader software for detection.
Use of the test is limited to Huntsville, Alabama-based Alimetrix.