I did some research on products that may be in a similar...

I did some research on products that may be in a similar position, regarding emergency use authorization


Here's an interesting chronology:

So the research for the clinical evaluation of this covid diagnistic test was published AFTER the device was given emergency use authorisation....

eg.

date research was published: Jul 6 2020
date authorisation was obtained: May 1 2020
date FDA permits marketing of diagnostic test: March 17 2021

I think this gives a bit of perspective in regards to NANOSEMED and DiaNose

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https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.

https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200031.pdf




https://pubmed.ncbi.nlm.nih.gov/32650276/
2020 Jul 6

Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2

Abstract
We evaluated the performance of the BioFire® Respiratory Panel 2.1 (RP2.1) in the detection of SARS CoV-2 in comparison against three other SARS CoV-2 EUA assays. In these studies, the RP2.1 panel had 98 % positive percent agreement (48/49) and 100 % negative percent agreement (49/49). Since 30 % of nasopharyngeal swab specimens have a SARS CoV-2 Ct >30 and thus detection of virus in low titers is clinically relevant, a sample with a high titer was diluted and each 10 fold dilution was tested in triplicate and compared against 6 other EUA approved SARS CoV-2 assays. These data suggested that the BioFire® RP2.1 panel, along with four other SARS CoV-2 assays (Roche cobas, Cepheid Xpert Xpress, BioFire® Defense COVID19, and NECoV19), consistently detected viral RNA at the 10-7 dilution. Overall, these studies suggest that the BioFire® RP2.1 assay can be used to detect acute cases of SARS CoV2 in addition to patients with low viral titer later in disease presentation.

https://www.biomerieux-usa.com/biomerieux-biofirer-respiratory-21-rp21-panel-sars-cov-2-obtains-de-novo-fda-authorization

BIOFIRE® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 Obtains De Novo FDA Authorization

This De Novo authorization will be concurrent with the revocation of the U.S. FDA EUA that was obtained on May 1st, 2020 for this panel.