27/06/2024, 18:05 BioMérieux Respiratory/Sore Throat Mini Panel Gets FDA Special 510(k) Clearance, CLIA Waiver | GenomeWeb
BioMérieux Respiratory/Sore Throat Mini
Panel Gets FDA Special 510(k) Clearance,
CLIA Waiver
Jun 26, 2024 | staff reporter
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NEW YORK – BioMérieux announced Wednesday that it has received special 510(k) clearance and
CLIA waiver from the US Food and Drug Administration for the BioFire SpotFire Respiratory/Sore
Throat (R/ST) Panel Mini test.
The SpotFire R/ST Panel Mini will be available in the US in the third quarter of 2024 and is intended
to be commercialized along with the company's larger R/ST panel, the firm said in a statement.
SpotFire R/ST Panel Mini is a 15-minute syndromic PCR panel to detect and differentiate five viral
and bacterial causes of respiratory or sore throat infections. Samples can be taken from a
nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when
pharyngitis is suspected.
The test detects human rhinovirus, influenza A, influenza B, and respiratory syncytial virus. In
addition to these four pathogens, for respiratory-only infections the test detects SARS-CoV-2, while
for sore throat-only samples the test detects Streptococcus pyogenes, otherwise known as group A
strep.
The R/ST mini panel is the fourth SpotFire assay to be FDA-cleared and CLIA-waived. The others
are the Respiratory (R) Panel, the Respiratory (R) Panel Mini, and the 15-target Respiratory/Sore
Throat (R/ST) Panel.
The same point-of-care SpotFire instrument can run the mini panels as well as the larger panel
assays, allowing clinicians to choose the right test for their patients, the firm said.
"The medical community continues to bring enhanced technology closer to patients, allowing
clinicians to have more information to make real-time decisions," Charles Cooper, executive VP and
chief medical officer at Marcy-l’Étoile, France-based BioMérieux, said in a statement.
Group A strep accounts for approximately 20 percent of sore throat cases and has historically been
diagnosed via antigen tests, Cooper said in a statement. "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,"
he added.
"Our offer meets the current needs of the growing decentralized, POC market bringing syndromic
testing to the frontline of patient care." Jennifer Zinn, BioMérieux's executive VP of clinical
operations, said in a statement. "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."
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27/06/2024, 18:05 BioMérieux Respiratory/Sore Throat Mini Panel Gets FDA Special 510(k) Clearance, CLIA Waiver | GenomeWeb
The SpotFire is an integral part of BioMérieux's recent five-year plan for future growth in molecular
diagnostics.
Filed Under Regulatory News & FDA Approvals Point-of-Care Testing
Molecular Diagnostics PCR BioMérieux BioFire multiplex PCR
Infectious Disease Respiratory Group A streptococcus COVID-19
influenza RSV common cold Europe FDA clearance
CLIA North America
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