Roche has received clearance from the US Food and Drug Administration (FDA) for its point of care diagnostic test for whooping cough (pertussis) and other Bordetella infections.
The test also received a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver and a CE mark.
There are around 24.1 million cases of whooping cough annually, and around 170,000 deaths from the infection. A significant issue is the similarity of early symptoms to other respiratory illnesses, making diagnosis challenging. Delaying diagnosis can lead to more severe outcomes, especially in vulnerable groups such as children; an early diagnostic test could help to prevent both complications and transmission of the disease.
Surges of whooping cough tend to peak in severity every three to five years; a surge in cases is currently underway, amplified by factors such as waning immunity, vaccine hesitancy and a pause in routine vaccinations during the COVID-19 pandemic.
Roche’s test not only detects Bordetella infections but also distinguishes between the three key strains. These are B. pertussis, the cause of classic whooping cough; B. parapertussis, which causes a milder illness which may not respond to standard treatments; and B. holmesii, an emerging pathogen increasingly associated with potential diagnostic challenges.
The test is delivered via the cobas liat system, which is already used for point of care diagnostics worldwide: existing respiratory disease applications of cobas liat include the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Group A Streptococcus (Strep A).
The test delivers polymerase chain reaction (PCR)-accurate results in 20 minutes or less. This rapid diagnosis could allow clinicians to diagnose patients in-consultation and prescribe the appropriate antibiotics, reducing severe outcomes, transmission and reliance on laboratory testing.
Matt Sause, CEO of Roche, said: “Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infections. This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier.”