ALK, a Denmark-based pharma company focused on allergies, has received the US Food and Drug Administration (FDA) approval for a new line of allergy skin testing devices and well trays.
The new line of allergy tests includes the AccuTest-1, AccuTest-8, and AccuTest-10 allergy skin testing devices, along with the AccuTest 48-well and 60-well allergen trays.
AccuTest-1 is a single skin prick testing device, while AccuTest-8 and AccuTest-10 are multi-head testing devices with 8-head and 10-head applicators, respectively.
The AccuTest 48-well and 60-well allergen well trays are compatible with single-prick and multi-head devices to provide enhanced flexibility and convenience.
ALK allergy extract, diagnostics, and life science business units executive director Jay Bates said: “We are proud of this important milestone underscoring our commitment to bringing innovative solutions to our customers and the millions of people who suffer from chronic allergies.
“The annual costs of allergies can or may be significant, adding clinical and economic burdens to the healthcare system. Identifying underlying allergen triggers through testing is the first step to effective diagnosis and treatment.”
The AccuTest-1 device comprises hardened plastic tines for maximum sharpness, which ensures precise testing with a single prick.
AccuTest-8 and AccuTest-10 tests are ergonomically designed with a large top surface area and ribbed grip to provide more uniform pressure, resulting in consistent and reliable results.
The AccuTest line of testing devices features smaller tine lengths and diameters to enhance accuracy and minimise discomfort to the patient.
AccuTest 48-well and 60-well allergen well trays feature an air-tight locking mechanism to prevent contamination and a non-slip rubber bottom for stability during testing procedures.
The features enable fixed positioning, minimise errors, and increase diagnostic accuracy.
A recent assessment of the impact of physical characteristics and precision of the AccuTest applicator, compared to two currently available FDA-approved skin prick tests.
The study showed that lower device variability may increase the reliability of results, said ALK.