Agency Draws a New Line on SARS-CoV-2 Antibody Serology Tests
It took a while but the FDA has finally come to the realization that letting blood-based serology tests for detection of SARS-CoV-2 antibody tests into the U.S. market without requiring test makers to prove the value of their products was a bad idea. And now the agency is walking back the policy, at least in part. The Umbrella Pathway After producers disregarded recommendations to do so voluntary, the FDA decided to require serology test makers to submit their products to federal labs for independent evaluation. The new “umbrella” pathway, which the agency unveiled on April 29, calls for an interagency testing group at the National Cancer Institute to assess the approximate specificity, sensitivity and overall predictive value of submitted tests against a panel of samples confirmed positive for anti-SARS CoV-2 IgM and IgG antibodies, as well as against confirmed antibody negative samples or pre-COVID-19 samples, with 10 of these 80 negative samples being HIV positive. To pass: Tests reporting on both IgM and IgG must show 90% overall sensitivity and 95% specificity; Tests reporting the immunoglobulins separately must have 70% sensitivity for IgM and 90% for IgG; and Tests must show no cross-reactivity with HIV. FDA Delists 27 SARS-CoV-2 Serology […]
It took a while but the FDA has finally come to the realization that letting blood-based serology tests for detection of SARS-CoV-2 antibody tests into the U.S. market without requiring test makers to prove the value of their products was a bad idea. And now the agency is walking back the policy, at least in part.
The Umbrella Pathway
After producers disregarded recommendations to do so voluntary, the FDA decided to require serology test makers to submit their products to federal labs for independent evaluation. The new “umbrella” pathway, which the agency unveiled on April 29, calls for an interagency testing group at the National Cancer Institute to assess the approximate specificity, sensitivity and overall predictive value of submitted tests against a panel of samples confirmed positive for anti-SARS CoV-2 IgM and IgG antibodies, as well as against confirmed antibody negative samples or pre-COVID-19 samples, with 10 of these 80 negative samples being HIV positive. To pass:
- Tests reporting on both IgM and IgG must show 90% overall sensitivity and 95% specificity;
- Tests reporting the immunoglobulins separately must have 70% sensitivity for IgM and 90% for IgG; and
- Tests must show no cross-reactivity with HIV.
FDA Delists 27 SARS-CoV-2 Serology Assays
The new evaluation process and standards apply to all serology SARS-CoV-2 assays, including the purported gold standard tests that received Emergency Use Authorization (EUA) under Policy C. But on May 4, the FDA put an end to its controversial Policy D, the less rigorous pathway allowing test makers to introduce their products immediately upon internal validation without seeking EUA clearance. All the test maker had to do was notify the agency in an email listing cursory validation data and product labeling. From now on, all SARS-CoV-2 serology kits will require EUA.
And now the FDA is peeling back the roster of tests that came through Policy D. Of the approximately 214 serology test kits previously listed as allowed for U.S. distribution under Policy D, 27 have been removed for failing to meet the new Umbrella pathway standards or submit the data necessary to perform the independent evaluation, including nine products that were withdrawn voluntarily. Most of the removed tests are manufactured overseas but the list also includes tests made by:
- Vita Testing (based in Beverly Hills);
- Diazyme Laboratories, a subsidiary of defense contracting giant General Atomics;
- Pharmatech, which was acquired by Caris Life Sciences last year; and
- BioMedomics, which developed a rapid fingerstick test formerly sold by Becton Dickinson.
Here are some of the key new FDA clearances announced in May:
New FDA Emergency Use Authorizations (EUAs) & Approvals
Manufacturer(s) | Product |
SpectronRx | EUA for Hymon SARS-CoV-2 Test Kit |
Exact Sciences | EUA for SARS-CoV-2 (N gene detection) Test |
Express Gene Molecular Diagnostics Laboratory | EUA for 2019-nCoV RT-PCR Diagnostic Panel |
Avera Institute for Human Genetics | EUA for SARS-CoV-2 assay run on the Applied Biosystems Quant Studio 7 Flex |
P23 Labs | EUA for TaqPath SARS-CoV-2 test |
BioCore | EUA for 2019-nCoV Real Time PCR Kit |
SolGent | EUA for DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit |
Seasun Biomaterials | EUA for AQ-TOP COVID-19 Rapid Detection Kit |
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 Molecular | Clearance for Vysis ALK Break Apart FISH Probe Kit for use as companion diagnostic to identify patients with ALK rearrangements likely to benefit from Takeda Pharmaceuticals’ newly approved brigatinib drug |
Abbott | EUA for Alinity m SARS-CoV-2 assay |
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 |
New CE Marks & Global Certifications
Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE
Manufacturer(s) | Product(s) |
GenScript Biotech Europe | cPass-SARS-CoV-2 Surrogate Virus Neutralization Test |
ArcDia International | SARS-CoV-2 antigen point-of-care test |
Xiamen Wiz Biotech | SARS-CoV-2 rapid antibody-detection kit |
Bio-Techne + Leica Biosystems | Bio-Techne’s RNAscope In Situ Hybridization Detection Kit for automation on Leica Biosystems Bond-III staining platform |
Siemens Healthineers | Test detecting SARS-CoV-2 IgM + IgG antibodies in blood |
Genedrive | Genedrive 96 SARS-CoV-2 Kit |
HiberGene Diagnostics | Rapid molecular test for SARS-CoV-2 |
BioMérieux | Two different SARS-CoV-2 serology tests |
Advanced Biological Laboratories | DeepChek sequencing-based assays for HIV genotyping and drug resistance testing |
Ortho Clinical Diagnostics | Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test |
CareDx | AlloSeq Tx 17 HLA typing product |
CeGaT | ELISA-based SARS-CoV-2 Corona Antibody Test |
Biomerica | COVID-19 IgG/IgM Rapid Test |
Eurofins Technologies | GSD NovaPrime SARS-CoV-2 test |
NeuMoDx | NeuMoDx SARS-CoV-2 Assay |
PlexBio | IntelliPlex SARS-CoV-2 Detection Kit |
Quotient Limited | MosaiQ COVID-19 Antibody Microarray |
BAG Diagnostics | ViroQ SARS-CoV-2 rapid PCR test |
Altona Diagnostics | RealStar SARS-CoV-2 RT-PCR Kit |
MosaiQ COVID-19 Antibody Microarray |
Other international clearances announced during the period:
Manufacturer(s) | Country(ies) | Product(s) |
Rendu Biotechnology | China | National Medical Products Administration emergency approval for SARS-CoV-2 nucleic acid detection kit |
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