FDA Watch

First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

The U.S. Food and Drug Administration (FDA) continues to step outside its traditional comfort zone in response to COVID-19 pandemic pressures. Among the most recent agency firsts is best seen as part of the current imperative to clear assays and collection kits for rapid and easy screening, including products that can be used in home settings. On April 6, the FDA crossed a new barrier by granting Emergency Use Authorization (EUA) for a SARS-CoV-2 antibody detection test used in dried blood spot samples collected at home.

The Symbiotica System

The product on the receiving end of the groundbreaking EUA was Symbiotica’s COVID-19 Self-Collected Antibody Test System, a prescription-only test designed to detect immunoglobulin G against SARS-CoV-2 in dried blood spots obtained via fingerstick. The kit includes lancets that individuals can use to collect the blood samples themselves and mail to Symbiotica’s California laboratory for analysis.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” noted Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.

Molecular Test Pooling

Two weeks after clearing the Symbiotica system, the agency amended its guidelines to facilitate authorization for pooling by allowing molecular COVID-19 tests which have previously received EUA to be used with pooled samples performed to screen the asymptomatic as part of a “serial testing program,” such as in a school or workplace setting. In other words, specific clearance for the use is not required as long as the test developer self-certifies that it has validated the test for pooling and submits its validation data and pooling procedures.

Here are some of the key new FDA EUAs and clearances announced in June:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Yale School of Public Health Reissued EUA allowing use of SalivaDirect SARS-CoV-2 test with additional thermocyclers
LetsGetChecked Reissued EUA allowing use of at-home COVID-19 sample collection kit for children as young as age 2
Amazon.com via STS Lab Holdco subsidiary EUA for Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2
Diabetomics EUA for CovAb SARS-CoV-2 Ab Test
OraSure Technologies EUA for InteliSwab COVID-19 Rapid Test for over-the-counter use
OraSure Technologies EUA for InteliSwab COVID-19 Rapid Test Pro for professional use at point-of-care
OraSure Technologies EUA for InteliSwab COVID-19 Rapid Test Rx for home use with a prescription
Sysmex America Clearance for XN-10 Automated Hematology Analyzer with Blood Bank mode
Thermo Fisher Scientific EUA for TaqPath COVID-19 Pooling Kit
Foundation Medicine Accelerated approval for FoundationOne CDx to identify advanced cholangiocarcinoma patients with FGFR2 fusions or rearrangements who are eligible to receive newly approved BridgeBio Pharma and Helsinn Group’s infigratinib (Truseltiq)
Qiagen Approval for Therascreen KRAS RGQ PCR kit as companion diagnostic for newly approved Amgen’s sotorasib (Lumakras) for previously treated, locally advanced, or metastatic non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation
Guardant Health Approval for s Guardant360 CDx as companion diagnostic for newly approved Amgen’s sotorasib (Lumakras) for previously treated, locally advanced, or metastatic non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation
DiaSorin EUA for Liaison SARS-CoV-2 TrimericS IgG chemiluminescent immunoassay
Salofa EUA for Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
Harvard University EUA for point of care immunoassay Quaeris SARS-CoV-2 Assay
NowDiagnostics EUA for AdexusDx COVID-19 Test lateral flow immunoassay
anssen Pharmaceutical Accelerated approval for EGFR-MET bispecific antibody amivantamab (Rybrevant) to treat EGFR exon 20-mutated NSCLC
Phosphorus Diagnostics EUA for direct-to-consumer version of saliva-based SARS-CoV-2 assay and use of at-home sample collection kit with test
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