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Acutis Diagnostics Gets FDA Emergency Use Authorization for COVID-19 RT-PCR Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an RT-PCR-based test for COVID-19 infection developed by Acutis Diagnostics.

The SARS-CoV-2 Acutis Multiplex Assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of having COVID-19.

The test may only be performed by Hicksville, New York-based Acutis, according to the FDA.

Earlier this year, Acutis struck a deal to incorporate Sophia Genetics analytics into a planned hereditary cancer sequencing assay.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.