FDA Watch: Monkeypox, COVID-19, and MDD Tests

A Roundup of Significant New Laboratory Test Approvals from the US and Around the World

New test approvals in October were light on volume but heavy in significance. Here are the top three approvals you should know about.

1. Abbott Scores First EUA for Commercial Monkeypox Test

Monkeypox testing in the US entered a new, commercial phase on Oct. 7 when the FDA announced that it had granted Emergency Use Authorization (EUA) to Abbott for commercial use of a test for the virus. The Alinity m MPXV assay detects DNA from the monkeypox virus in lesion swab samples of acute pustular or vesicular rash in viral transport media during the acute phase of infection. In the clinical validation study, the test accurately identified the monkeypox virus at two and four times the limit of detection, detecting the virus in all 36 samples used in the study while also correctly determining the absence of the virus from 35 negative samples.

This is the second monkeypox PCR test to receive EUA clearance. On Sept. 7, the FDA granted Quest Diagnostics EUA for its Monkeypox Virus Qualitative Real-Time PCR test. The difference is that unlike the Quest test, the Abbott kit is authorized for commercial use.

Even so, the scope of the EUA is narrow, only allowing CLIA-certified moderate and high complexity test labs to use the Alinity m MPXV test. In addition, under the authorization, the test must be run on Abbott’s Alinity m System or other authorized instruments that automatically execute sample preparation, PCR assembly, amplification, detection, and results calculation and reporting.

2. FDA OKs First OTC At-Home Saliva Test for COVID-19

The standard method of detecting upper respiratory viruses like SARS-CoV-2 is to test tissue samples from the back of the sinus cavity collected by inserting a long nasopharyngeal swab deep into the nostril. Testing on saliva simples is easier, faster, and more comfortable. However, saliva-based tests for COVID-19 have been largely a sideshow. Early in the public health emergency (PHE), Rutgers University scored the first EUA for a saliva COVID-19 test, the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay test which runs on the Thermo Fisher Applied Biosystems QuantStudio 5 Real-Time PCR System. More than 30 saliva-based kits have received EUA during the PHE, many for use at the point of care.  

On Oct. 18, the FDA broke some new ground by issuing the first EUA for an over-the-counter saliva-based COVID molecular test to Aptitude Medical Systems for the Metrix COVID-19 Test, a single-use test that uses real-time loop-mediated isothermal amplification (RT-LAMP) with a fluorescence reader to detect the SARS-CoV-2 virus.

3. Genetika+ Gets European Clearance for MDD Personalized Treatment Test

Israeli startup Genetika+ made big news in Europe by securing CE-IVD marking for NeuroKaire, a blood-based, artificial intelligence-driven test for predicting a major depressive disorder (MDD) patient’s response to different antidepressant treatments. The combination of patient-reported symptoms, pharmacogenetics testing, and functional testing of the blood sample enables physicians to personalize and design optimal treatment for individuals suffering from MDD. The results of the validation study “confirm the utility of our brain-in-a-dish technology, reflecting the individual patient’s response to the drug in the target organ,” noted Genetika+ chief executive officer and co-founder Talia Cohen Solal in the press release announcing the approval.

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Here are some of the key new FDA EUAs and clearances that were announced in October 2022:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s)	Product
Sol Millennium	510(k) clearance for Sol-Guard Safety Pull Button Blood Collection Set spring-activated needle retraction device
Aptitude Medical	EUA for Aptitude Medical assay, first COVID-19 single-use saliva test to receive approval for over-the-counter home use
Copan Diagnostics	510(k) approval for Colibrí pre-analytical processor automating steps in diagnostic microbiology specimen preparation
Abbott	EUA for Alinity m MPXV assay, first PCR monkeypox test to get EUA for commercial use
Boston Cell Standards	510(k) clearance for IHControls panel for slide quality control for breast cancer immunohistochemistry assays
Roche	Approval for use of Pathway Anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test as companion diagnostic for AstraZeneca and Daiichi Sankyo's Enhertu (fam-trastuzumab deruxtecan-nxki)
Thermo Fisher Scientific	Approval of next-generation sequencing-based Oncomine Dx Target Test as companion diagnostic to identify patients with advanced RET-driven lung and thyroid cancers who may be eligible for Lilly’s Retevmo (selpercatinib)
Becton Dickinson	Approval of updated version of BD Max Enteric Viral Panel to detect norovirus GI and GII, rotavirus A, adenovirus F40/41, sapovirus genogroups 1-5, and human astrovirus
Agendia	Approval for MammaPrint FFPE NGS breast cancer prognosis kit

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Manufacturer(s)	Product(s)
Genetika+	NeuroKaire AI-powered blood test enabling physicians to personalize treatment for major depressive disorder (MDD)
MedMira	Vyra COVID-19 Antigen Test
Roche	New versions of SARS-CoV-2 rapid antigen tests: • SARS-CoV-2 Rapid Antigen Test 2.0 • SARS-CoV-2 Rapid Antigen Test 2.0 Nasal • SARS-CoV-2 Antigen Self Test Nasal
Thermo Fisher Scientific	TaqPath Enteric Bacterial Select Panel to detect common gastrointestinal (GI) bacteria
Olive Diagnostics	Optical toilet-mounted Olive KG instrument for passive urinalysis

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
SQI Diagnostics	Canada	Rapid Acute Lung Injury Diagnostic (RALI-Dx) blood-based assay to identify COVID-19 patients at highest risk of developing severe lung disease
BGI Australia	Australia	NATA approval for performing clinical whole-exome sequencing
Standard BioTools (formerly called Fluidigm)	China	Biomark and Juno molecular diagnostic systems
Diagnostics for the Real World	New Zealand	• SAMBA II SARS-COV-2 test • SAMBA II CoV-2/FluA/FluB test • SAMBA II SARS-CoV-2/RSV test