Roche Receives FDA Clearance With CLIA Waiver for Its First Molecular Point-of-Care Test

Roche announced that its first point-of-care test for the detection of Bordetella infections, including whooping cough (pertussis), has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver. The groundbreaking PCR test uses the cobas® liat system to deliver results in just 15 minutes at the point of care. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission.

Pertussis is a global burden, affecting people of all ages but can be more severe in children, causing an estimated 24.1 million cases and 170,000 deaths annually. A major diagnostic challenge is that early symptoms are often indistinguishable from other respiratory illnesses. 

Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infection. This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier. 

The test not only detects Bordetella infections but also differentiates between three key species:

• B. pertussis, the cause of classic whooping cough.
• B. parapertussis, which causes a milder pertussis-like illness.
• B. holmesii, an emerging pathogen increasingly associated with pertussis-like symptoms and potential diagnostic challenges.

Whooping cough has a cyclical prevalence that typically peaks in severity every three to five years. With a surge underway, the increase in cases has been further amplified by interruptions in routine vaccinations during the COVID-19 pandemic, along with waning immunity and vaccine hesitancy. These factors have driven infections across all age groups, including older children and adults, where symptoms can be less typical and harder to recognise. 

Bordetella infections, including whooping cough, pose a significant challenge for clinicians because their early symptoms resemble those of other respiratory infections. Accurately identifying Bordetella among these conditions is essential to delivering the right treatment and ensuring timely intervention.

About cobas^® liat

The point-of-care (POC) test is delivered using the cobas^® liat system, already used by healthcare professionals worldwide for point-of-care diagnostics. The compact system delivers PCR definitive results in 20 minutes or less to aid in patient-care decisions. This new assay expands the cobas^® liat system’s capabilities, complementing existing solutions for the detection of SARS-CoV-2, Influenzas A and B, Respiratory Syncytial Virus (RSV), and Group A Streptococcus (Strep A). By enabling clinicians to test for a range of conditions during the patient consultation, the system empowers faster, more decisive care decisions and reduces reliance on central laboratory facilities.