Roche announced Monday, November 2, that the U.S. Food and Drug Administration has granted 510(k) clearance for its cobas eplex respiratory pathogen panel 3, a laboratory test designed to identify up to 19 viral and bacterial targets from one nasal swab sample.
The company said the panel delivers results in under two hours and requires less than one minute of hands-on preparation. Laboratories can choose among as many as five panel configurations to match local disease patterns and patient needs, according to Roche’s announcement.
The clearance adds another testing option for clinicians dealing with respiratory illnesses that can cause similar symptoms. The test is intended for the automated cobas eplex system and uses a single nasopharyngeal swab to look for multiple possible causes of infection.
Among its targets are influenza A, respiratory syncytial virus and SARS-CoV-2. The new panel adds Bordetella pertussis, the bacterium that causes whooping cough, and updates assays for influenza and SARS-CoV-2 to improve coverage of circulating strains, Roche said.
One sample, several testing choices
The flexible configurations require cobas eplex system software version 3.0 or higher. The company describes the process as an automated sample-to-answer workflow, with qualitative results showing whether the targeted pathogens are detected rather than measuring an amount.
Roche said quicker identification can help clinicians make treatment and patient-management decisions during busy respiratory seasons. Its announcement particularly pointed to the needs of older patients, young children and people with weakened immune systems, who can face greater risk of complications.
The company’s claims about workflow and turnaround describe the product’s stated capabilities. They do not mean that every patient will receive a result within two hours of arriving for care, since sample collection, transport and laboratory operations can add time.
The new panel expands the company’s existing respiratory testing range. Roche noted an important regulatory distinction: its earlier respiratory pathogen panel 2 operates under an FDA emergency use authorization and has not itself received FDA clearance or approval. Monday’s announcement concerns the 510(k) clearance of panel 3.
Dan Malarek, president and chief executive of Roche Diagnostics North America, said the product gives laboratories more choices with quicker turnaround. For laboratories, the practical change is a cleared multiplex panel with configurable testing, rather than a test that must be used in the same configuration for every patient population.
JBizNews Desk | New York
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