The Top 10 Most Significant FDA New Lab Test Approvals of 2022

Across the Atlantic, the new European Union In Vitro Diagnostics Regulation (IVDR) that took effect in May has clearly acted as a drag on new lab test approvals. But back in the US, it’s been business as usual with hundreds of new tests and diagnostic devices receiving clearance from the FDA in 2022. While the majority of these were COVID-19 tests cleared via the Emergency Use Authorization (EUA) pathway, there was also a sharp rebound in approvals for non-COVID products. Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.

1. CRISPR-Based SARS-CoV-2 Test (Mammoth Biosciences)

Among the roughly 100 COVID-19 products to receive new or expanded EUA clearance this year, Mammoth Biosciences’ DETECTR Boost SARS-CoV-2 Reagent Kit was the only one based on CRISPR technology. Comarketed by Mammoth and Agilent, the assay is being touted as allowing for rapid, high-throughput testing with PCR-equivalent performance.

2. The Alzheimer’s 6

The FDA cleared a record number of lab tests for Alzheimer’s disease in 2022, starting on January 18, 2022, when Diadem’s AlzoSure Predict blood-based biomarker prognostic assay for early prediction of the disease received breakthrough device designation. Before the end of the year, the agency would green light five other Alzheimer’s tests:

• • AltPep’s blood-based Soba-AD test (breakthrough device, March 1);

• • Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test (De Novo classification, May 4);

• • Roche’s Elecsys Amyloid Plasma Panel qualitative test for symptomatic patients (breakthrough device, July 19);

• • Roche’s Elecsys Beta-Amyloid (1-42) CSF II cerebrospinal fluid-based (CSF) test (510(k) clearance, Dec. 8); and

• • Roche’s Elecsys Phospho-Tau (181P) CSF II test (510(k) clearance, Dec. 8).

3. The SARS-CoV-2 510(k) Transition Test Trio

Early into the public health emergency (PHE), the FDA called on COVID-19 test makers to consider transitioning from EUA to full premarket approval. In 2022, three producers demonstrated their long-term commitment to COVID testing by securing 510(k) clearance for erstwhile EUA products:

• • The BioFire Defense COVID-19 Test 2, developed in collaboration with the U.S. Army Warfighter Protection and Acute Care Project Management Office (Jan. 21, 2022);

• • The DiaSorin Simplexa COVID-19 Direct Kit (Sept. 14); and

• • The Roche SARS-CoV-2 Qualitative PCR test (Oct. 24).

4. The BRACAnalysis CDx (Myriad Genetics)

More than a dozen different lab tests received FDA clearance as companion diagnostics (CDx) to identify patients who could potentially benefit from novel drug treatments in 2022. Among the most important of these was Myriad Genetics’ BRACAnalysis CDx to identify patients with germline BRCA1/2 mutations who are eligible for treatment with AstraZeneca and Merck’s Lynparza (olaparib), which on the same day that BRACAnalysis was cleared as a CDx (March 11), became the first drug approved by the FDA for early-stage breast cancer patients with BRCA1/2 mutations.

5. The Aptima CMV Quant Test (Hologic)

On May 10, Hologic announced that the FDA had approved its Aptima CMV Quant assay, which uses plasma and whole-blood samples to quantify the viral load of cytomegalovirus in patients who’ve had solid organ or stem cell transplants. The assay, which runs on the firm’s Panther platform, is the first in a planned line of quantitative tests for use in patient care after transplant surgery.

6. The Minuteful Kidney ACR Test for Home Use (Healthy.io)

On July 12, smartphone urinalysis company Healthy.io received 510(k) clearance for home use of its Minuteful kidney damage test to measure levels of albumin in urine, which may be an early sign of kidney disease. Patients use the sample cup to collect their urine, into which they dip a testing strip. Using the color board contained in the kit, they then go to the Healthy.io app to measure their albumin to creatinine ratio (ACR).

7. The StrivePD Parkinson’s Disease Monitoring App (Rune Labs)

On June 13, the FDA granted 510(k) clearance to brain data startup RuneLabs for StrivePD, an app that enables Parkinson’s disease patients to monitor their symptoms and medications via the Apple Watch. The product is the result of a strategic collaboration between RuneLabs and Medtronic formed in 2021.

8. The Guardant360 CDx (Guardant Health) and Oncomine Dx Target (Thermo Fisher Scientific) Tests

On Aug. 12, Guardant Health and Thermo Fisher announced that they had received FDA premarket approvals for their respective next-generation sequencing assays as companion diagnostics to identify candidates for treatment with Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca for non-small cell lung cancer (NSCLC). Guardant Health’s Guardant360 CDx is a blood-based liquid biopsy assay that analyzes genomic alterations in circulating tumor DNA across 55 genes. Thermo Fisher’s Oncomine Dx Target detects alterations in 23 genes associated with NSCLC.

9. The Monkeypox 5

Declaration of a PHE for monkeypox in the summer cleared the way for five different lab tests detecting the virus to enter the US market via the FDA’s EUA pathway:

• • Quest Diagnostics’ Monkeypox Virus Qualitative Real-Time PCR test (Sept. 7);

• • Abbott’s Alinity m MPXV assay, the first monkeypox test cleared for commercial use (Oct. 7);

• • Roche’s RT-PCR test run on the firm’s Cobas 6800/8800 systems (Nov. 15);

• • Thermo Fisher Scientific’s Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit (Dec. 14); and

• • Becton Dickinson’s Viasure Monkeypox virus Real-Time PCR Reagents for BD Max System test (Dec. 23).

10. The Eonis SCID-SMA Test (PerkinElmer)

On Nov. 12, PerkinElmer secured FDA clearance to market an assay that simultaneously detects spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID). The Eonis SCID-SMA assay kit is the first SMA screening assay for newborns to receive FDA authorization, according to the company. It’s designed for use with dried blood spot samples on PerkinElmer’s Eonis real-time PCR instrument. The kit actually traveled two pathways to reach the US market, with the SMA portion of the test receiving De Novo and the SCID portion getting 510(k) clearance.

****

Here are some of the key new FDA EUAs and clearances that were announced at the end of November 2022 and in December:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s)	Product
OnsiteGene	EUA for Hi-Sense COVID-19 Molecular Testing Kit 1.0, an RT-qPCR-based assay
CTK Biotech	EUA for ImmuView COVID-19 Antigen Home Test, an over-the-counter test
Foundation Medicine	Clearance for FoundationOne Liquid CDx test as companion diagnostic for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI)
MedCognetics	510(k) clearance for QmTriage AI platform
Acon Laboratories	EUA for Flowflex COVID-19 Antigen Rapid Test, nasal swab-based point-of-care assay
Yale School of Public Health’s Department of Epidemiology of Microbial Diseases	EUA for SalivaDirect COVID-19 assay allowing authorized labs to use pre-assembled SalivaDirect Unsupervised Collection Kits for at-home sample collection
Thermo Fisher Scientific	EUA for Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, PCR test
Thermo Fisher Scientific	De Novo clearance for SeCore CDx HLA Sequencing System as companion diagnostic to Immunocore’s Kimmtrak (tebentafusp-tebn) therapy for uveal melanoma
Agilent Technologies	Clearance for Agilent Resolution ctDx FIRST next-generation sequencing-based liquid biopsy assay as companion diagnostic to identify patients likely to benefit from Mirati Therapeutics’ drug Krazati (adagrasib) for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Qiagen	Clearance for therascreen KRAS RGQ PCR kit as companion diagnostic to identify patients likely to benefit from Mirati Therapeutics’ drug Krazati (adagrasib) for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
Diazyme Laboratories	EUA for Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit
Roche	510(k) clearance for Elecsys Beta-Amyloid (1-42) CSF II assay measuring beta-amyloid biomarkers for Alzheimer’s disease in patients 55 and older being evaluated for the disease
Roche	510(k) clearance for Elecsys Phospho-Tau (181P) CSF assay measuring tau protein biomarkers for Alzheimer’s disease in patients 55 and older being evaluated for the disease
Virax Biolabs	EUA for Over-the-Counter COVID-19 Rapid Antigen Test
HemoSonics	510(k) clearance for QStat Cartridge assay to provide point-of-care hemostasis data during trauma and liver transplantation procedures
Lucira Health	EUA for molecular COVID-19 and Flu Test for use at the point of care developed in collaboration with the US National Institutes of Health’s Independent Test Assessment program
Azure Biotech	EUA for Fastep COVID-19 Antigen Home Test
CorDx	EUA for CorDx COVID-19 Ag Test at-home antigen assay
Premier Medical Laboratory Services	EUA for Diversified Medical Healthcare SARS-CoV-2 Assay real-time RT-PCR-based test done on nasal swab specimens collected at home using the DoINeedaCOVID19Test.com Self-Collection Kit

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Manufacturer(s)	Product(s)
BioMérieux	Vidas Kube automated immunoassay system
SeekIn	PanCanSeek Cancer Mutation Detection Kit
SeekIn	SeekInCure cancer recurrence monitoring test
Lunit	Lunit INSIGHT AI solutions for radiology

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
Sysmex	Japan	Blood-based HISCL β-Amyloid 1-42 Assay Kit and HISCL β-Amyloid 1-40 Assay Kit for Alzheimer’s disease
QuidelOrtho	Canada	TriageTrue High-Sensitivity Troponin I test, single-use fluorescence immunoassay for rapid point-of-care myocardial infarction diagnosis
QuantuMDx	UK	Q-POC SARS-CoV-2, Flu A/B & RSV Assay
Lunit	UK	Lunit INSIGHT AI solutions for radiology
Novacyt	UK	Genesig COVID-19 3G Real-Time PCR test