December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Here are three of the most significant new diagnostics tests and products that gained regulatory clearance from the FDA and the European Union (EU) in the past month.
1. Grifols Gets FDA Clearance for DTC Use of COPD-Related Assay
The FDA cleared Grifols’ AlphaID cheek swab test for alpha1-antitrypsin (AAT) deficiency for direct-to-consumer (DTC) use.1 AAT deficiency is an inherited disorder and common risk factor for chronic obstructive pulmonary disorder (COPD). In 2019, the agency gave the green light to market the test for use with a prescription. The newly expanded clearance allows for use of the test with saliva samples collected at home with OraSure’s ORAcollect Dx collection device, which had previously been available via prescription only.2
2. FDA Clears First OTC At-Home Saliva Test for COVID-19
On Oct. 18, the FDA broke new ground by issuing the first Emergency Use Authorization (EUA) for an over-the-counter (OTC) 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
Context: 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.
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+ CEO and co-founder Dr. Talia Cohen Solal in the press release announcing the approval.4
References:
- https://www.prnewswire.com/news-releases/grifols-receives-fda-clearance-for-alphaid-at-home-the-first-free-service-for-us-consumers-to-determine-their-risk-for-alpha-1-301667630.html
- https://orasure.gcs-web.com/news-releases/news-release-details/orasure-technologies-receives-general-clearance-its
- https://www.fda.gov/media/162401/download
- https://www.prnewswire.com/il/news-releases/genetika-announces-ce-mark-for-neurokaire-its-ai-powered-tool-to-optimize-depression-treatment-301653411.html
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Here are some of the other key new FDA EUAs and clearances that were announced from late October through mid-November 2022:
New FDA Approvals & Emergency Use Authorizations (EUAs)
New CE Marks & Global Certifications
New CE Markings in Europe
Other international clearances announced during the period:
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