Multiplex PCR Test Detects Common Viral and Bacterial Causes of Respiratory or Sore Throat Infections in 15 Minutes

The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs.

bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected. When implementing decentralized testing, CLIA-waiver is vital as it allows for the use of this system and panels by non-lab professionals in POC settings where patients require care such as urgent care, physician offices, local pharmacies, student health clinics, or emergency departments.

The BIOFIRE® SPOTFIRE® system is a unique POC platform that delivers fast results and offers flexibility with the capability to run either a large multiplex respiratory test with up to 15 pathogens with the BIOFIRE® SPOTFIRE® R/ST Panel, already FDA-cleared and CLIA-waived, or a small multiplex respiratory test with five pathogens with the BIOFIRE® SPOTFIRE® R/ST Panel Mini. This flexibility enables clinicians to select the appropriate test for their patients. The BIOFIRE® SPOTFIRE® R/ST Panel Mini has become the fourth panel of the BIOFIRE® SPOTFIRE® range to achieve FDA clearance and CLIA waiver. bioMérieux will make the new BIOFIRE® SPOTFIRE® R/ST Panel Mini available in the third quarter of 2024 in the U.S. bioMérieux intends to commercialize the BIOFIRE® SPOTFIRE® R/ST Panel Mini along with the larger multiplex BIOFIRE® SPOTFIRE® R/ST Panel to further expand its presence in the North American outpatient market.

“The medical community continues to bring enhanced technology closer to patients, allowing clinicians to have more information to make real-time decisions,” said Dr Charles K. Cooper, Executive Vice-President and Chief Medical Officer. “Regarding strep throat, Group A Streptococcus accounts for approximately 20% of sore throat cases and has historically been diagnosed via antigen tests. Including it on this PCR panel with common viral causes of strep throat, including rhinovirus, represents a step forward in healthcare, ultimately increasing diagnostic yield and removing the need to reflex to culture in most patients.”

“With our BIOFIRE® SPOTFIRE® R/ST Panel Mini, we bring a fast, highly sensitive, and targeted panel to test for 4 of the most common respiratory viruses (including influenzas) and Streptococcus A, from one throat swab, all at the same time,” added Jennifer Zinn, Executive Vice President, Clinical Operations. “Our offer meets the current needs of the growing decentralized, POC market bringing syndromic testing to the frontline of patient care. With this innovation, clinicians now can confidently tell their patients quickly what is making them sick and get them on the right treatment pathway, limiting the overuse of antibiotics.”