November 2022 FDA Watch: Pace of New Approvals Slows

After a super busy August, the pace of new regulatory approvals fell off considerably. However, the impact of the products that did gain approval more than made up for the relative reduction in volume. Here are the three biggest stories to take away from the month (not including the first FDA Emergency Use Authorization (EUA) to Abbott for commercial use of a monkeypox virus test, which is covered in a separate story):

1. Roche Antibody Test Gets FDA Clearance as Companion Diagnostic

Roche gained FDA approval for its Pathway Anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, a test designed to detect metastatic breast cancer in patients with low HER2 expression, for use as a companion diagnostic (CDx) to identify patients that could benefit from treatment with AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki). The Roche test includes a scoring algorithm enabling pathologists to distinguish between HER2-negative and low expressor HER2 patients.  

2. Thermo Fisher NGS Lung Cancer Assay Gets CDx Clearance

The other major CDx product to score FDA clearance during the period was Thermo Fisher Scientific’s Oncomine Dx Target Test, a next-generation sequencing-based assay, for use in identifying people with advanced RET-driven lung and thyroid cancers who may be candidates to be treated with Lilly’s Retevmo (selpercatinib). According to Thermo, this is the Oncomine Dx Target Test's first approval as a CDx for a therapy targeting RET-positive thyroid cancer and its second approval in RET-positive non-small cell lung cancer (NSCLC).

3. Roche Gets Green Light to Launch New COVID-19 Rapid Antigen Tests in Europe

It was a fruitful month for Roche Diagnostics, particularly on the rapid COVID-19 antigen test front. On Oct. 3, the laboratory testing arm of the Swiss pharmaceutical giant announced that it was launching its SARS-CoV-2 Rapid Antibody Test 2.0 in countries that recognize the European CE mark, having received the mark in July. A week later, a new version of the product was among the three updated SARS-CoV-2 rapid antibody tests for which Roche gained new CE marking.    

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Here are some of the key new FDA EUAs and clearances that were announced from late September through mid-October 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
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)
Roche	510(k) clearance for its compact, modular testing system, Cobas pure integrated solutions
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
Oxford Immunotec (PerkinElmer subsidiary)	Clearance for T-Cell Select reagent kit automating sample preparation for firm's T-SPOT.TB interferon-gamma release TB screening test
Rheonix Inc.	Expanded EUA for COVID-19 MDx Assay to include home collection using firm’s COVID-19 PCR Test Saliva Home Collection Kit
DiaSorin	510(k) clearance for Simplexa COVID-19 Direct Kit COVID-19 PCR assay that delivers results in about an hour
Tasso	510(k) clearance for Tasso+ blood collection device as a Class II medical device

New CE Marks & Global Certifications

Notable European CE certifications announced during the period: 

New CE Markings in Europe

Manufacturer(s)	Product(s)
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)
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