Roche Diagnostics has secured US Food and Drug Administration (FDA) 510(k) approval for cobas Respiratory 4-flex test, designed to enhance respiratory testing.
The cobas Respiratory 4-flex is the first FDA-cleared assay employing Roche’s TAGS (Temperature-Activated Generation of Signal) technology.
It offers accurate PCR results for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), enabling timely and precise diagnoses.
The cobas Respiratory 4-flex test consolidates four key respiratory virus targets into a single assay, streamlining laboratory workflows and optimising resource use.
It integrates with Roche’s cobas 5800, 6800, and 8800 molecular lab instruments.
The solution allows laboratories to customise testing based on physician orders and patient needs, which can reduce the necessity for repeat healthcare visits and tests.
The assay features the ‘digital reflex’ option, which facilitates additional testing from the same sample.
If initial results for influenza A and B are negative, further testing for SARS-CoV-2 or RSV can be requested, ensuring relevant tests are conducted efficiently.
Raw data for all targets is generated, but only requested results are analysed and reported, focusing on targeted testing.
Roche Diagnostics North America president and CEO Brad Moore said: “The cobas Respiratory 4-flex assay offers a significant technological advancement that empowers labs to address evolving respiratory testing demands now and in the future.
“The expanded testing capabilities, enabled by TAGS technology, will allow labs to deliver reliable and relevant patient testing, while also optimizing healthcare resources.”
The cobas Respiratory 4-flex test expands Roche’s respiratory portfolio, which already includes singleplex and multiplex assays for viral and bacterial infections.
The assay supports patient testing needs across the care continuum, enhancing the ability of healthcare providers to deliver effective patient care.
Roche’s TAGS technology, integral to the cobas Respiratory 4-flex test, leverages multiplex polymerase chain reaction (PCR) testing.
It combines colour, temperature, and data processing to enable the detection and differentiation of multiple targets within a single optical channel.
Also, the diagnostic test supports expanded testing capabilities in future.
Roche Diagnostics molecular solutions and infectious disease chief medical partner Denise Heaney said: “Our goal for the Respiratory 4-flex is to allow labs to customise testing based on clinical needs, patient symptoms, which are often similar, and to better support a constantly shifting respiratory landscape.
“TAGS technology allows for the detection of more targets on a high-throughput platform, which supports diagnostic stewardship while reaching a broader patient population.”
