Phadia, a provider of allergy, asthma and autoimmunity diagnostics, has received the US Food and Drug Administration (FDA) 510(k) approval for its recombinant ImmunoCAP Allergen Components.
The FDA clearance covers 13 components (9 recombinants and 4 natives) including peanut, cat dander, dust mite, bermuda grass, ragweed and the mold Alternaria alternata.
Jaffe Food Allergy Institute director and Mount Sinai School of Medicine Pediatrics professor Hugh Sampson said recent studies suggest that component testing will help allergy and immunology specialists assess the risk of clinical reactions.
Phadia president and general manager David Esposito said by identifying the specific molecule within the allergen causing the allergic reaction, clinicians have information to enhance patient care.
"Allergen component test results have the potential to assess risk for reaction, explain symptoms due to cross reactivity, and identify a more targeted approach for patients requiring immunotherapy," Esposito said.
Phadia has plans to accelerate its ongoing commitment to educate clinicians and patients on the use of ImmunoCAP test results to support improved patient care.