FDA Watch: Key Lab Test Clearances of 2023

The FDA issued a number of important clearances for lab tests in 2023, both commercial and laboratory developed. Here’s an overview of what G2 Intelligence considers key approvals and Breakthrough Device Designations across four crucial clinical applications.

Cancer and liquid biopsy

Just three days into 2023, Burning Rock announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) had been granted Breakthrough Device Designation by the FDA, clearing the way for expedited approval of the test.¹ The test is approved for the early detection of esophageal, liver, lung, ovarian, and pancreatic cancers in adults ages 50 to 75 who are at average risk for cancer. Manufactured in the US and China, the test received CE marking in Europe in May 2022.

Five months later, rival liquid biopsy company Nucleix secured 510(k) clearance for Bladder EpiCheck^®, a noninvasive qPCR-based test used in conjunction with cystoscopy that analyzes disease-specific changes in 15 DNA methylation markers in urine. The test helps to monitor patients previously diagnosed with invasive bladder cancer for tumor recurrence.²

The FDA also awarded 510(k) clearance for a pair of tests targeting Lynch syndrome in colorectal cancer patients:

• • the Biocartis Idylla™ MSI Test, an assay that uses PCR and melt-curve analysis to differentiate sporadic colorectal cancer from potential Lynch syndrome, and³

• a Lynch syndrome screening assay called the BOND MMR Antibody Panel from Danaher subsidiary Leica Biosystems.⁴

On September 29, the FDA granted De Novo authorization for Invitae’s Common Hereditary Cancers Panel, a DNA sequencing test identifying variants in 47 genes associated with a high risk of certain cancers.⁵ In conjunction with the approval, the agency also announced that it’s opening the 510(k) premarket pathway for future tests of the same type and intended use, giving test makers the option of securing premarketing authorization by demonstrating the device’s substantial equivalence to a predicate device.⁶

COVID-19 and respiratory tests

Although the official ending of the COVID-19 Public Health Emergency slowed the pace of Emergency Use Authorizations (EUAs), the FDA COVID-19 pipeline continued to flow in 2023. The big story was the increased use of traditional premarket pathways for tests targeting the SARS-CoV-2 virus. Many of the products that made the transition from EUA to 510(k) status were multiplex assays targeting SARS-CoV-2 in combination with other respiratory viruses, including influenza A and B and/or respiratory syncytial virus (RSV).

Multiplex SARS-CoV-2 Tests Receiving FDA 510(k) Clearance in 2023

Company	Product
BioFire (bioMérieux subsidiary)	BIOFIRE® SPOTFIRE® Respiratory (R) Panel and System, modular platform for molecular syndromic testing targeting 15 respiratory pathogens
BioFire (bioMérieux subsidiary)	BIOFIRE® SPOTFIRE® Respiratory Panel Mini for SARS-CoV-2, influenza A & B, RSV, and Rhinovirus
DiaSorin	Simplexa™ COVID-19 & Flu A/B Direct RT-PCR assay
Hologic	Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay
Roche	cobas® SARS-CoV-2 & Influenza A/B test for use on the cobas® Liat® System
Becton Dickinson	BD Respiratory Viral Panel for BD MAX™ System targeting SARS-CoV-2, influenza A and B, and RSV
Cepheid (Danaher subsidiary)	Xpert® Xpress CoV-2/Flu/RSV plus RT-PCR for detection and differentiation of SARS-CoV-2, influenza A and B, and/or RSV

Several other EUA tests for COVID-19 received full premarketing authorization during the year, including:

• • QuidelOrtho’s VITROS^® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator and VITROS^® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator, which were cleared under the De Novo pathway in May;⁷

• • Cue Health’s COVID-19 Molecular Test at-home over-the-counter assay, which received De Novo clearance in June; and⁸

• the Flowflex^® COVID-19 Antigen Home Test from ACON Laboratories, which received 510(k) clearance in November.⁹

Key STI test clearances

On November 15, the FDA announced that the Simple 2 Test from LetsGetChecked had become the first test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization. As it did in approving the genetic variant cancer risk assessment test from Invitae, the agency also established a template that makers of other at-home sample collection STI tests can use to secure 510(k) clearance.¹⁰

Other important STI test clearances during the year included the CLIA waiver awarded to Chembio Diagnostics in February for its DPP HIV-Syphilis System rapid fingerstick dual target test.¹¹

Neurologic tests

Abbott has been working on a blood-based laboratory-developed test for diagnosing traumatic brain injury (TBI), aka, concussion, at the point of care since 2014. On March 7, the lab giant announced that its test had been cleared by the FDA. The assay, which runs on the firm’s Alinity^® i laboratory instrument and provides results in 18 minutes, measures two blood biomarkers associated with brain injury, with a negative result ruling out the need for a CT scan.¹²

Meanwhile, lab companies continued to make progress in Alzheimer’s disease (AD) testing, adding more tools to aid in faster diagnoses. The highlight came in June when Roche announced that it had secured 510(k) clearance for a pair of assays that measure p-tau and beta amyloid ratio—key biomarkers of AD—in cerebrospinal fluid (CSF). The approvals for the Elecsys^® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys^® Total-Tau CSF (tTau) assays should bolster Roche’s position in the market.¹³

References:

1. 1. https://ir.brbiotech.com/news-releases/news-release-details/burning-rock-received-fda-breakthrough-device-designation-its

1. 1. https://nucleix.com/wp-content/uploads/2023/05/PR_Nucleix_Bladder-EpiCheck-FDA-Clearance.pdf

1. 1. https://www.biocartis.com/en-US/meet-idylla/idylla-oncology-assays/idylla-msi-test-now-510k-cleared

1. 1. https://www.leicabiosystems.com/us/news-events/leica-biosystems-strengthens-portfolio-with-fda-clearance-of-class-ii-mismatch-repair/

1. 1. https://ir.invitae.com/news-and-events/press-releases/press-release-details/2023/Invitaes-Common-Hereditary-Cancers-Panel-Receives-FDA-Market-Authorization/default.aspx

1. 1. https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types

1. 1. https://www.quidelortho.com/us/en/resources/press-releases/quidelortho-receives-fda-de-novo-classification-for-two-sars-cov-2-antibody-tests

1. 1. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process

1. 1. https://www.aconlabs.com/acon-receives-fda-510k-clearance-for-flowflex-covid-19-test-will-be-manufactured-in-san-diego/

1. 1. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection

1. 1. https://chembio.com/chembio-announces-the-receipt-of-clia-waiver-for-its-dpp-hiv-syphilis-system/

1. 1. https://abbott.mediaroom.com/2023-03-07-Abbott-Receives-FDA-Clearance-for-First-Commercially-Available-Lab-based-Blood-Test-to-Help-Evaluate-Concussion

1. https://diagnostics.roche.com/us/en/news-listing/2023/roche-fda-clearance-additional-alzheimers-disease-cerebrospinal-fluid-ttau.html

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Here are the key new FDA clearances that were announced in the period from mid-November through mid-December 2023:

New FDA Approvals and Emergency Use Authorizations (EUAs)

Manufacturer(s)	Product
Abbott	Approval for GLP systems Track™ lab automation system
MedMira	510(k) clearance for Reveal® G4 Rapid HIV-1/2 antigen test that MedMira claims will help address demand for comprehensive HIV screening across US
GENETWORx	EUA for Gx HTIQ SARS-CoV-2 Test, PCR assay for COVID-19
Bioporto	510(k) clearance for ProNephro AKI™ test assessing risk of moderate to severe acute kidney injury in pediatric patients
Becton Dickinson	510(k) clearance for BD MiniDraw™ Capillary Blood Collection System for obtaining blood samples from a fingerstick
DiaCarta	510(k) clearance for iColon Fecal Occult Blood Test, over-the-counter test for early, at-home detection of blood in stool
First Light Diagnostics	Clearance for SensiTox® B. anthracis Toxin Test to detect the infectious agent that causes anthrax toxicity
Roche	EUA for new version of cobas® SARS-CoV-2 & Influenza A/B v2 RT-PCR assay to detect and differentiate SARS-CoV-2, influenza A, and influenza B RNA that is run on Roche’s cobas® 6800/8800 instruments
Foundation Medicine (Roche subsidiary)	Approval for FoundationOne®CDx as companion diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) for treating adult patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/ AKT1/ PTEN-alterations after progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of finishing adjuvant therapy
Ad Astra Diagnostics	510(k) clearance for QScout™ point-of-care hematology system for white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiation of five types of mature WBCs as well as immature granulocytes

New CE marks and global certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s)	Product(s)
Roche	Elecsys® HBeAg quant immunoassay for qualitative and quantitative detection of hepatitis B e antigen in human serum and plasma
Revvity	EONIS™ Q system molecular testing platform for spinal muscular atrophy and severe combined immunodeficiency in newborns

Other international clearances announced during the period:

Manufacturer(s)	Country	Product(s)
DnaNudge	Ghana	RT-PCR test that detects SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus on a single “Quad” testing cartridge
Dinfectome	China	DIFSEQ-200 compact desktop sequencer for next-generation sequencing-based testing