FDA announced Friday evening June 10, 2022, that it had awarded LabCorp an EUA for an NGS-based COVID sequencing test. The test runs on a Pac Bio Sequel II platform.
- Brief notice at Genomeweb here.
- Provider fact sheet here. Patient sheet here.
- EUA letter here.
- 16-page performance and intended use sheet here.
I'm not sure how many NGS-based EUA tests there are, but to the day, exactly two years prior FDA had issued an EUA for an Illumina COVID sequencing test - here. The Illumina 2020 test was a packaged test (sold like an IVD) but partial targeted sequencing of COVID. The LabCorp test provides for EUA-endorsed full sequencing of COVID, but at LabCorp facilities (not in a kit).
For the new LabCorp EUA NGS test, samples will first be identified as positive (such as LabCorp COVID PCR Test or COVID/INF-A-B test. (Ct < 31). The probe set includes 1000 tiled molecular loop inversion probes (MIPS) reaching "99.6% of the SARS CoV-2 genome with most bases covered by 22 MIPs." The instructions note that up to 752 specimens (8 plates) can be processed in one batch.
See earlier 2021 press release about LabCorp using a Molecular Loop Bioscience research panel for viral surveillance, here. See a current LabCorp page on variant testing, here.
Recall that in February 2022, AMA created a new COVID test code 87913 to report "mutation identification in targeted regions," 87913. (This is less extensive that a full sequencing code). This will be item #68 in the CMS Annual Lab Meeting for new code pricing on June 23. Possible crosswalks might include the nearly-adjacent older code 87910 for viral genotyping ($257). On the other hand, there could be a premium for COVID testing, and CMS has placed a number of the COVID lab codes into the gapfill process during the last couple years.