Industry continues to build COVID-19 testing capacity
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Diagnostics companies are continuing to step up to meet demand for expanded COVID-19 testing capabilities with a range of PCR- and antibody-based tests.
PCR-based tests for COVID-19 detect active infection with SARS-CoV-2, while antibody-based tests detect anti-SARS-CoV-2 antibodies. Given the long-lived nature of antibodies, the latter type of test should also be able to identify individuals who have recovered from infection, including those who never developed symptoms.
On Thursday, Aperiomics Inc. launched its PCR-based Xplore-COVID-19 test in the U.S. and said it can process up to 1,000 tests per week, while CTK Biotech launched both its OnSite COVID-19 IgG/IgM Rapid Test, which detects anti-SARS-CoV-2 IgG and IgM antibodies in human serum, plasma or whole blood, and its Aridia COVID-19 Real-Time PCR Test in the "international market." CTK plans to launch its tests in the U.S. following completion of validation studies and FDA clearance.
Meanwhile, FDA granted an Emergency Use Authorization (EUA) to two additional PCR-based tests: the ePlex SARS-CoV-2 test from GenMark Diagnostics Inc. and the Simplexa COVID-19 Direct test from DiaSorin Molecular LLC.
Two companies also announced plans to launch at-home tests in the U.S.
Everlywell Inc. plans to launch an at-home PCR test on March 23 and will initially supply 30,000 tests. The company plans to ramp up to 250,000 tests per week. The COVID-19 test will be delivered to patients' homes; patients will collect samples and ship them to a CLIA-certified lab partner.
Scanwell Health Inc. has licensed exclusive rights from China-based manufacturer Innovita to distribute a blood-based antibody test for at-home use. The company plans to obtain an EUA from FDA and launch the COVID-19 test in the U.S. in six to eight weeks, with initial rollouts in Washington, California, New York and other "severely affected" states. Patients will receive test kits via home delivery and share results through the Scanwell app; the results will then be evaluated by a telehealth doctor or nurse practitioner.
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