FDA Watch

Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be used in home settings. A new barrier was crossed on April 6 when the agency granted 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 groundbreaking EUA went to 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 lab 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 with 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 isn’t 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 the other key new FDA EUAs and clearances announced in May:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
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
Janssen 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
LabCorp EUA for Pixel by Labcorp COVID-19 PCR Test Home Collection Kit expanded to allow for use by children and adolescents at least 2 years of age
Molzym Breakthrough Device Designation for molecular diagnostic test system for diagnosis of bloodstream infections
Zeus Scientific EUA for ELISA SARS-CoV-2 Total Antibody Test System
Qiagen EUA for QiaReach Anti-SARS-CoV-2 Total Test to identify if person has SARS-CoV-2 antibodies from a prior infection
InBios International EUA for point-of-care SCoV-2 Ag Detect Rapid Test for SARS-CoV-2 antigens
Viome Breakthrough Device Designation for mRNA analysis and AI saliva-based oral and throat cancer detection technology
Quadrant Biosciences Breakthrough Device Designation for Clarifi ASD assay to detect markers of autism spectrum disorder
Roche Clearance for Ventana MMR RxDx immunohistochemistry panel as companion diagnostic to select endometrial cancer patients for treatment with dostarlimab
PathogenDx EUA for molecular DetectX-Rv SARS-CoV02test
Southern California Permanente Medical Group EUA for SCPMG’s Kaiser Permanente High Throughput SARS-CoV-2 Assay
Inova Diagnostics EUA for Quanta Flash SARS-CoV-2 IgG chemiluminescent immunoassay
Immunodiagnostic Systems 510(k) clearance for IDS Cortisol assay to detect cortisol in human serum and plasma on firm’s IDS system
Retractable Technologies 510(k) clearance for EasyPoint Blood Collection Plus blood collection tube holder
Immunalysis 510(k) clearance for Sefria PCP Oral Fluid Enzyme Immunoassay

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product(s)
Lucid Diagnostics EsoCheck Esophageal Cell Collection Device with Collect+Protect technology
Advanced Biological Laboratories DeepChek Assay Whole Genome SARS-CoV-2 Genotyping V1
Advanced Biological Laboratories UltraGene SARS-CoV-2 Triplex Assay
BGI Genomics DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C Genes in colorectal cancer screening
Tasso Tasso-M20 self-sampling blood collection device
Genomtec Saliva-based SARS-Cov-2 EvaGreen Direct-RT-LAMP Kit
BforCure Chronos Dx portable qPCR thermocycler for use in SARS-CoV-2 testing
Becton Dickinson Human papillomavirus assay with at-home self-collection indication
Bio Molecular Systems Portable MIC qPCR thermo cycler
BioEcho Life Sciences EchoLution Viral RNA/DNA Swab Kit
Ortho Clinical Diagnostics Vitros Anti-SARS-CoV-2 IgG Quantitative Antibody test
Purigen Biosystems Ionic Purification System for nucleic acid isolation
BioMérieux Vitek MS Prime, its new MALDI-TOF microbiology system
BioMérieux Vidas SARS-CoV-2 IgG II test
Siemens Healthineers Clinitest Rapid COVID-19 Antigen Self-Test for unsupervised self-testing, including testing at home on the asymptomatic
Bio-Rad Laboratories Reliance SARS-CoV-2 RT-PCR Kit
SpeeDx PlexPCR SARS-CoV-2 test

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Bio Molecular Systems Australia Portable MIC qPCR thermo cycler
Lucira Health Canada Lucira Check It COVID-19 test kit
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