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. **** 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