Respiratory and Throat Infection PCR Test Detects Multiple Pathogens with Overlapping Symptoms

By LabMedica International staff writers
Posted on 29 Mar 2024

Image: The BIOFIRE® SPOTFIRE® R/ST Panel has received dual 510(k) clearance and CLIA-waiver approval (Photo courtesy of bioMérieux)

The COVID-19 pandemic has demonstrated the need for healthcare professionals to have diagnostic tests available as close as possible to the patient, providing actionable results quickly. Now, a fast and innovative syndromic testing range fully meets this new medical need globally.

bioMérieux (Marcy l'Etoile, France) has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel. The BIOFIRE® SPOTFIRE® R/ST Panel is a unique multiplex PCR test designed to detect and identify 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 obtained from a nasopharyngeal swab in case of suspected respiratory tract infection, or from a throat swab if pharyngitis syndrome is suspected.

The BIOFIRE® SPOTFIRE® R/ST Panel has become the third panel to receive FDA clearance for use on the BIOFIRE® SPOTFIRE® System. The two other panels available for use on this system are the BIOFIRE® SPOTFIRE® Respiratory (R) Panel and BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini, detecting 15 and 5 of the most common respiratory pathogens, respectively. The 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 urgent care, physician office, local pharmacy, student health clinic, or an emergency department.

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). bioMérieux also plans to submit the BIOFIRE® SPOTFIRE® Respiratory / Sore Throat (R/ST) Panel Mini to the FDA for review for a 510(k) clearance. This panel is designed to detect and identify nucleic acids from five of the most common viral and bacterial causes of respiratory tract infections from either a nasopharyngeal or throat swab, respectively. The BIOFIRE® SPOTFIRE® R/ST Panel Mini is yet to go on sale.

“To prescribe or not to prescribe antimicrobials is the age-old question for outpatient upper respiratory infections,” said Dr. Charles K. Cooper, Executive Vice-President, Chief Medical Officer, bioMérieux. “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.”

“Receiving FDA clearance for the BIOFIRE® SPOTFIRE® R/ST Panel, just one year after the successful launch of the BIOFIRE® SPOTFIRE® solution, 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.”