Today's Topline - 4/1/20
Wednesday, April 1, 2020
Source: MedTech Association
Today’s numbers continue to show an alarming rise in positive COVID-19 cases and resulting deaths. Health experts agree that we remain firmly in the upward swing of the disease’s progression. In a bit of promising news, however, our partners at AdvaMed released information about the bio/med industry’s herculean efforts to increase the availability of COVID-19 testing. Within the last few weeks, 17 diagnostics companies have received FDA Emergency Use Authorizations (EUA) and are rapidly scaling up testing capacity. This has happened in a matter of days since the first commercial IVD for the coronavirus received FDA authorization on March 12, thanks to the fast work of many of our member companies and the FDA.
Hundreds of thousands of COVID-19 tests have been performed. Millions are now available, including several point-of-care tests that provide results in under an hour, and one that takes just five minutes. By mid-April, monthly capacity for commercial COVID-19 tests will be in the tens of millions. It’s an incredible accomplishment.
Tests that have received EUAs from FDA for COVID-19 include:
- Roche’s Cobas SARS-CoV-2 Test.
- Hologic’s Panther Fusion SARS-CoV-2 test.
- Quidel's Lyra SARS-CoV-2 Assay.
- Thermo Fisher's TaqPath COVID-19 Combo Kit.
- Abbott's RealTime SARS-CoV-2 test.
- Abbott’s ID Now COVID-19 test.
- DiaSorin's Simplexa COVID-19 Direct assay.
- GenMark’s ePlex Test.
- Cepheid’s Xpert Xpress SARS-CoV-2 Test.
- Primerdesign’s COVID-19 Genesig Real-Time PCR Assay.
- BioFire Defense’s COVID-19 Test.
- Mesa Biotech’s Accula SARS-Cov-2 Test.
- Perkin Elmer’s New Coronavirus Nucleic Acid Detection Kit.
- BGI Genomics’s RT-PCR Kit.
- Luminex’s NxTAG CoV Extended Panel Assay.
- NeuMoDx’s SARS-CoV-2 Assay.
- Qiagen’s QIAstat-Dx Respiratory SARS-CoV-2 Panel.
Additional COVID-19 IVDs that are available and being performed around the country, and in the process of securing EUAs, include:
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