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Kwokman Dx Gets FDA EUA for SARS-CoV-2 Molecular Testing Sample Collection Kit

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Kwokman Diagnostics' at-home nasal swab specimen collection kit for SARS-CoV-2 testing.

The Kwokman Diagnostics COVID-19 Home Collection Kit is designed for the at-home self-collection of anterior nasal swab specimens for use with in vitro diagnostics that detect SARS-CoV-2 RNA. The kit is for use by individuals at least 18 years old.

Testing of samples collected with the kit is limited to labs CLIA-certified to perform high-complexity tests and designed by Irvine, California-based Kwokman, according to the FDA.

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.