Wednesday, May 6, 2020

FDA EUA for Biofire Panel Plus COVID: What's It Look Like?

A couple days ago, it was announced that Biofire had obtained an FDA Emergency Use Authorization for an elaborate respiratory pathogen panel - push the COVID virus, SARS-CoV-2.  See e.g. Genomeweb here.  And Biofire has a webpage for its COVID-related test solutions, here.

What's the actual FDA paperwork look like?   FDA has a lengthy dedicated webpage for COVID EUA's - here.   Scroll down and you'll find In Vitro Diagnostic EUAs, which FDA divides into institutional (aka LDT - see Mayo Clinic, Exact Sciences, Stanford...) and IVDs (e.g. kits running on platforms.)

IVD EUA's generally generate four pieces of FDA paperwork:  (1) And EUA letter, (2) Instructions to healthcare providers (HCPs), (3) Instructions to patients, and (4) Instructions for use (IFU: for the machine and platform.)     Institutional EUAs have the same paperwork but lack #4.

For the Biofire panel, called RP 2.1,

  • HCP fact sheet here.
  • Patient fact sheet here.
  • Panel platform IFU - in this case, 55 pages.  Here.
  • Brief FDA authorization letter here.
Interpretation of results show "interpretation" on page 13 forward.  For SARS-CoV-2, spike protein (S gene) and membrane protein (M gene) are detected, and reported as positive if either is positive.  There are elaborate instructions for the testing and interpreting of the other panelized pathogens.

Extensive limitations, many pathogen-specific for the panel tests, are at page 17 forward.

Extensive tables of expected values follow, but on page 20, it's noted that "expected values for SARS CoV 2 have not been determined."   However, concordance (48/49) for other platforms like Panther Fusion and ROche are shown in Table 10, page 23.  There are also comparisons of the performance of Panel 2.1 versus the original panel 2.0 (2.1 having had SARS CoV 2 added).

Example Screenshots

Table 6, Panel Testing with Actual Specimens

Table 8, Co-Positive Specimens (Library of 1612 specimens)

Table 10, SARS CoV 2 Orthogonal Accuracy