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

New CE Marks & Global Certifications

Notable European CE certifications announced during the period: 

New CE Markings in Europe

Other international clearances announced during the period: