Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Quest's Respiratory Virus Molecular Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing a molecular respiratory virus test made by Quest Diagnostics' Focus Diagnostics business, the firm said today.

The agency granted 510(k) clearance for the Focus Diagnostics Simplexa Flu A/B & RSV test for use on the 3M Integrated Cycler. The Simplexa RT-PCR test is intended to aid in the detection and discrimination of influenza A, influenza B, and respiratory syncytial virus infections.

According to Quest, it is the first molecular test approved by the FDA for detecting flu viruses and RSV that does not require confirmation of test results by other time-consuming methods, such as culture. The time to perform the Simplexa test following RNA extraction from a specimen takes about an hour, said Quest, with results expected to be reported in less than three hours.

The Simplexa test uses nasal or nasopharyngeal specimens and reports if a patient is positive or negative for infection with one or more of the three classes of viruses.

"For many physicians and lab administrators, it will eliminate the time-consuming step of sending a specimen to a reference lab for molecular testing to detect flu and RSV infection," John Hurrell, VP and GM of Focus Diagnostics, said in a statement.

The Scan

Expanded Genetic Testing Uncovers Hereditary Cancer Risk in Significant Subset of Cancer Patients

In Genome Medicine, researchers found pathogenic or likely pathogenic hereditary cancer risk variants in close to 17 percent of the 17,523 patients profiled with expanded germline genetic testing.

Mitochondrial Replacement Therapy Embryos Appear Largely Normal in Single-Cell 'Omics Analyses

Embryos produced with spindle transfer-based mitochondrial replacement had delayed demethylation, but typical aneuploidy and transcriptome features in a PLOS Biology study.

Cancer Patients Report Quality of Life Benefits for Immune Checkpoint Inhibitors

Immune checkpoint inhibitor immunotherapy was linked in JAMA Network Open to enhanced quality of life compared to other treatment types in cancer patients.

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.