COVID-19 Test Availability Rapidly Scales Up
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today released the following statements by Scott Whitaker, AdvaMed president and CEO, and Susan Van Meter, executive director of AdvaMedDx, regarding the medtech industry’s ongoing response to the coronavirus pandemic:
“Within just the last few weeks, 17 diagnostics companies have received FDA Emergency Use Authorizations (EUA) and are rapidly scaling up capacity for COVID-19 testing,” said Scott Whitaker, president and CEO of AdvaMed. “All of 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, just as critically, FDA.
“So far, 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. And more are on the way.”
“AdvaMedDx member companies are supporting large reference laboratories, hospital laboratories, and increasingly – with greater availability of rapid, point-of-care tests – emergency departments, physician offices, urgent care facilities and clinics,” said Susan Van Meter, executive director of AdvaMedDx. “All these tests complement one another across the health care delivery system. We commend the remarkable work that health care providers and the laboratory community are doing to perform these essential tests,” Van Meter said.
“Medtech companies on the front lines of the coronavirus crisis are working 24/7, doing absolutely everything they can to make sure everyone has access to the tools they need to prevent, diagnose and treat this disease,” Whitaker continued. “They’ve significantly increased production of essential equipment and supplies, including personal protective equipment (PPE) and ventilators.
“As the entire medtech industry continues to do all we can to address the COVID-19 pandemic, we also commend the hard work and support of the White House task force, HHS, FDA, CDC, FEMA, Congress, and other key officials. We will continue to work with them and all stakeholders to facilitate patient access to medtech during this crisis,” Whitaker concluded.
For more information on the medtech industry’s response to the COVID-19 pandemic, click here. For a listing of currently available coronavirus tests, see below.
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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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.