The BioFire SpotFire Respiratory Sore Throat (R/ST) Panel received FDA 510(k) clearance and CLIA) waiver approval, according to bioMérieux.

RT’s Three Key Takeaways

  1. bioMérieux’s BioFire SpotFire R/ST Panel, cleared by the FDA and granted CLIA waiver approval, swiftly detects common respiratory and sore throat infections.
  2. The BioFire SpotFire R/ST Panel utilizes multiplex PCR to identify nucleic acids from up to 15 prevalent pathogens associated with respiratory or sore throat infections within 15 minutes.
  3. With its CLIA waiver, healthcare professionals can use the system to guide antimicrobial prescriptions, improving patient care and advancing stewardship efforts.

bioMérieux received FDA 510(k) clearance for the BioFire SpotFire Respiratory Sore Throat (R/ST) Panel. The product also received Clinical Laboratory Improvement Amendments (CLIA) waiver approval, according to the company.

About the Diagnostic

The BioFire SpotFire R/ST Panel is a multiplex PCR test capable of detecting and identifying nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected, or from a throat swab in case of a pharyngitis syndrome.

“To prescribe or not to prescribe antimicrobials is the age-old question for outpatient upper respiratory infections. The flexibility of this syndromic panel allows healthcare professionals to test for multiple pathogens with overlapping signs and symptoms, ultimately allowing the diagnostic to drive informed decision-making during the outpatient visit. These results further empower the advancement of antimicrobial stewardship and modernize patient care.” declared Dr Charles K. Cooper, Executive Vice-President, Chief Medical Officer, bioMérieux

CLIA Waiver

A CLIA-waiver allows the BioFire SpotFire System and its so-authorized panels to be used by non-lab professionals and in any clinical setting where patients seek care including an urgent care, physician office, local pharmacy, student health clinic, or an emergency department.

“Receiving FDA clearance … just one year after the successful launch … marks another milestone in our mission to move testing closer to the patient,” said Jennifer Zinn, Executive Vice President, Clinical Operations, bioMérieux. “With our innovative approach, we are committed to enhancing patient care by providing healthcare professionals with the tools they need to deliver expedited and effective diagnoses. Together, we are revolutionizing the landscape of healthcare, one diagnosis at a time.”

More Information

The BioFire SpotFire R/ST Panel is currently CE-marked under IVDD (In Vitro Diagnostic Directive) and has been submitted for CE-marking under IVDR (In Vitro Diagnostic Regulation). More information is available on the bioMérieux website.