FDA Watch

After Initial Resistance, Agency Warms to Home COVID-19 Testing

Back in March, the US Food and Drug Administration (FDA) stated that the newly liberalized clearance scheme it was deploying to expedite the COVID-19 diagnostic testing pipeline did not apply to at-home testing due to concerns about the marketing of fraudulent test kits. However, the agency seems to have reversed that policy and recently broke new ground by authorizing coronavirus testing by multiple laboratories in nasal samples collected by consumers using an at-home kit.

The Rutgers and LabCorp Assays

At-home sample collection of COVID-19 test samples also some obvious advantages over the standard method in which a qualified health care professional armed to the teeth in personal protective equipment inserts a swab into the nostrils to access and perform a tissue scrape of the nasopharynx at the back of the nasal cavity. On April 13, the FDA granted Emergency Use Authorization (EUA) to the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay, version of the Thermo Fisher Scientific Applied Biosystems TaqPath COVID-19 Combo Kit modified to allow for testing on saliva samples that can be collected at home. Just over a week later, the agency gave LabCorp the go-ahead for at-home sample collection.

However, these approvals of at-home sample collection had only marginal impact on overall COVID-19 testing capacity since in each case, the EUA was limited to testing at each approvee’s respective laboratory. As a result, neither Rutgers nor LabCorp are authorized to ship the at-home samples collected using their kits to third party laboratories for analysis.

The Everlywell At-Home Collection Kit

On May 15, the FDA took things to the next level by granting EUA clearance to a kit created by Austin, Texas-based Everlywell for COVID-19 testing by separate CLIA-certified laboratories using assays that also received EUA clearance that same day. Specifically, the Everlywell COVID-19 Test Home Collection Kit has now been cleared for self-collection of nasal samples and subsequent analysis by Fulgent Therapeutics using the Fulgent COVID-19 by RT-PCR Test and by Assurance Scientific Laboratories using the Assurance SARS-CoV-2 Panel.

Takeaway: More to Come?

The Everlywell EUA also includes language leaving open the possibility of authorizing other high complexity-certified CLIA laboratories to perform testing using the Everlywell kit, “provided that the data are submitted in an EUA request that demonstrate the accuracy of each test.” according to the agency.

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Here are some of the other key new FDA clearances announced in May:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Color EUA for Color SARS-CoV-2 LAMP Diagnostic Assay using loop-mediated isothermal amplification (LAMP) technology
Myriad Genetics Clearance for BRACAnalysis CDx as companion diagnostic to identify patients with germline BRCA1/2 mutations who can benefit from newly approved AstraZeneca and Merck’s olaparib (Lynparza) drug
Foundation Medicine Clearance for FoundationOne CDx as companion diagnostic to identify patients with to identify patients with HRR-mutated genes who can benefit from newly approved AstraZeneca and Merck’s olaparib (Lynparza) drug
Ventana Medical Systems Clearance for VENTANA PD-L1 SP142 Assay as companion diagnostic device for identifying metastatic non-small cell lung cancer (NSCLC) patients who can benefit from Genentech’s newly approved atezolizumab (Tecentriq) drug
Agilent Technologies Clearance for expanded use of PD-L1 IHC 28-8 pharmDx as companion diagnostic to identify NSCLC patients who can benefit Bristol Myers Squib’s Opdivo and Yervoy’s from NSCLC who are appropriate for treatment with nivolumab and ipilimumab drug
Bio-Rad Clearance for CFX96 Dx real-time PCR instrument for in vitro diagnostic testing
Quidel Expanded EUA for Lyra SARS-CoV-2 assay to detect virus without an upfront nucleic acid extraction step
Quidel EUA for Sofia 2 SARS Antigen FIA assay
Everlywell EUA for COVID-19 Test Home Collection kit
Fulgent Therapeutics EUA for Fulgent COVID-19 by RT-PCR Test
Assurance Scientific Laboratories EUA for SARS-CoV-2 Panel
GeneMatrix EUA for NeoPlex COVID-19 Detection Kit
Hologic EUA for Aptima SARS-CoV-2 assay
Cedars-Sinai Medical Center EUA for SARS-CoV-2 RT-PCR assay
One Health Laboratories EUA for SARS-CoV-2 Real-Time RT-PCR Test
Applied DNA Sciences EUA for Linea COVID-19 RT-PCR test
Columbia University EUA for Triplex CII-SARS-CoV-2 rRT-PCR test
Thermo Fisher Scientific Expanded EUA for Applied Biosystems TaqPath COVID-19 Combo Kit
Abbott EUA for Alinity m SARS-CoV-2 assay
Abbott EUA for SARS-CoV-2 IgG serology blood test
1drop EUA for 1copy COVID-19 qPCR Multi Kit
BioMérieux EUA for SARS-CoV-2 R-Gene test kit
Opti Medical Systems EUA for Opti SARS-CoV-2 RT-PCR kit
Sherlock Biosciences EUA for Sherlock CRISPR SARS-CoV-2 kit
Grifols Diagnostic Solutions Clearance for Procelix Panther System featuring Automation Ready Technology (ART)
Siemens Healthineers EUA for Fast Track Diagnostics SARS-CoV-2 test
Euroimmun (owned by PerkinElmer) EUA for Anti-SARS-CoV-2 ELISA serology test
Roche EUA for Elecsys Anti-SARS-CoV-2 antibody serology test
Bio-Rad Laboratories EUA for 2019-nCoV CDC ddPCR Triplex Probe Assay for use on firm’s QX200 and QXDx Droplet Digital PCR systems
BioFire Diagnostics EUA for Respiratory Panel 2.1
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