Thermo Fisher Scientific has begun promoting a blood test designed to support the diagnosis of peanut allergies.
The test, which received 510(k) clearance from FDA last year, assesses whether a patient has antibodies against Ara h 6, a protein component of peanuts.
Ara h 6 is one of several peanut components that can cause allergic reactions and as such the test could help determine the status of patients without performing oral food challenges.
People with peanut allergies can be sensitive to various components of the nuts, including Ara h 1, 2, 3, 6 and 9. Prevalence of antibodies against the different allergens vary by geography, with some research suggesting antibodies against Ara h 9 are particularly common in people from the Mediterranean region. Overall, Ara h 1 to 3 and Ara h 6 are typically seen as the key allergens.
Thermo Fisher has developed a range of ImmunoCAP in vitro quantitative assays to help healthcare professionals determine whether patients are allergic to particular components of peanuts or suffer from cross-reactivity. Those efforts led to tests for antibodies against the storage proteins Ara h 1 to 3, as well as Ara h 8 and 9.
More recently, Thermo Fisher has expanded its test menu to cover Ara h 6. Rebecca Rosenberger, senior manager, clinical affairs and education at Thermo Fisher, contends the additional assay will lead to more accurate diagnoses.
"Adding the Ara h 6 test to the existing ImmunoCAP peanut component assays enables us to provide a more complete view of a patient's overall peanut sensitization, including whether a patient is at risk for cross-reactivity," Rosenberger said in a statement.
Thermo Fisher thinks that, in some cases, the assay could eliminate the need to perform oral food challenges, which entail giving a patient measured doses of a food to test if they react. In addition, Thermo Fisher expects results from the assay to improve understanding of patients’ risk factors and, by extension, lead to more tailored, effective management strategies.
Phadia, a subsidiary of Thermo Fisher, filed for FDA 510(k) clearance of an ImmunoCAP test for the allergen component Ara h 6 toward the end of 2017 and received a positive response last year. Thermo Fisher has now begun promoting the Ara h 6 test.
Between 0.5% to 1.5% of the U.S. population has a peanut allergy, yet there are few available treatments. The potential market has lured several drugmakers, including Aimmune Therapeutics Inc. and DBV Technologies SA, to work on new therapies.