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Needs to Work

Developers of antibody tests for SARS-CoV-2 now must seek Emergency Use Authorization for their tests from the US Food and Drug Administration, as GenomeWeb reports.

Previously, the agency had only required that companies affirm their tests are valid and label them as unapproved, Reuters writes, noting that the agency had at that time been "under pressure to move fast" following the slow introduction of diagnostic SARS-CoV-2 tests. But Politico reported last week that a number of antibody tests on the market are not accurate. Reuters additionally reported last week that this laissez-faire approach opened the door to fraudsters.

"Flexibility never meant we would allow fraud," Anand Shah, FDA's deputy commissioner for medical and scientific affairs, and Jeff Shuren, director of the Center for Devices and Radiological Health, write in a statement posted to the FDA site. "We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans' anxiety."

Under the new guidance issued by FDA, antibody test developers must file for an Emergency Use Authorization and provide certain validation data.

The Scan

ChatGPT Does As Well As Humans Answering Genetics Questions, Study Finds

Researchers in the European Journal of Human Genetics had ChatGPT answer genetics-related questions, finding it was about 68 percent accurate, but sometimes gave different answers to the same question.

Sequencing Analysis Examines Gene Regulatory Networks of Honeybee Soldier, Forager Brains

Researchers in Nature Ecology & Evolution find gene regulatory network differences between soldiers and foragers, suggesting bees can take on either role.

Analysis of Ashkenazi Jewish Cohort Uncovers New Genetic Loci Linked to Alzheimer's Disease

The study in Alzheimer's & Dementia highlighted known genes, but also novel ones with biological ties to Alzheimer's disease.

Tara Pacific Expedition Project Team Finds High Diversity Within Coral Reef Microbiome

In papers appearing in Nature Communications and elsewhere, the team reports on findings from the two-year excursion examining coral reefs.