Diagenode already sells more than 30 real-time PCR tests that are CE-marked for the detection of bacteria, parasites, and viruses for multiple infectious diseases.
The assay from San Diego-based Cue is the first molecular test authorized by the US Food and Drug Administration for home use without a doctor's prescription.
The company also said that a previously granted EUA for its Alinity m SARS-CoV-2 assay has been expanded to include asymptomatic individuals and pooled testing.
The firm said that with the addition of a target for SARS-CoV-2, its high-throughput NxTag syndromic respiratory panel includes 19 viral and two bacterial targets.
Hologic said that the transaction further strengthens its molecular diagnostics business by expanding its international capabilities, among other benefits.
The company's nucleic acid extraction kits have offered labs relief from COVID-19-related shortages of traditional silica-based bind-wash-elute assays.
The firm said its test eliminates the need for automated extraction systems in a high-volume PCR laboratory, reducing processing time, cost, and labor.
President Joe Biden is seeking an increase in federal spending, including higher budgets for the National Institutes of Health and Centers for Disease Control and Prevention.
