ALK Announces U.S. FDA Approval of New AccuTest™ Allergy Skin Testing Devices for Optimized Allergy Testing and Diagnosis
Rhea-AI Summary
ALK, a global pharmaceutical company focused on allergy prevention, diagnosis, and treatment, has announced FDA approval for its new AccuTest™ line of allergy skin testing devices. The innovative product range includes:
1. AccuTest-1™: Single skin prick testing device
2. AccuTest-8™ and AccuTest-10™: Multi-head applicators with 8 and 10 heads respectively
3. AccuTest™ 48-well and 60-well allergen trays
These devices feature improved ergonomics, smaller tine lengths and diameters for increased accuracy and patient comfort. The allergen trays have an air-tight locking mechanism and non-slip rubber bottom for stability. A recent study suggests that AccuTest™'s lower device variability may increase result reliability compared to two currently FDA-approved skin prick tests.
Positive
- FDA approval of new AccuTest™ allergy skin testing devices
- Improved ergonomics and design for more consistent and reliable results
- Potential for increased diagnostic accuracy and patient comfort
- Compatible allergen well trays with contamination prevention features
- Study suggests AccuTest™ may provide more reliable results than current FDA-approved tests
Negative
- None.
– The innovative AccuTest™ features a range of single prick and multi-head skin testing devices and well trays to improve the accuracy of allergy diagnosis and testing –
The new line consists of the single skin prick testing device, AccuTest-1™, and the multi-head AccuTest-8™ and the AccuTest-10™. The multi-head applicators are 8-head and 10-head models, respectively, and are designed with enhanced ergonomics, like larger top surface area and ribbed grip, for more uniform pressure leading to more consistent and reliable results. Both single prick and multi-head devices feature smaller tine lengths and diameters, to increase accuracy and minimize discomfort to the patient.
The AccuTest™ allergen well trays are compatible with the single prick and multi-head devices for increased flexibility and convenience. The trays are equipped with an air-tight locking mechanism for contamination prevention, feature a non-slip rubber bottom, offering stability during testing procedures. This unique feature ensures fixed positioning and minimizes the risk of errors, contributing to diagnostic accuracy.
"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," said Jay Bates, Executive Director, Allergy Extract, Diagnostics, & Life Science Business Units, ALK. "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."
ALK is confident in the innovative new device and is proud of a recent study that examined the impact of physical characteristics and precision of the applicator on clinical performance of AccuTest™ and two currently available FDA approved skin prick tests. Results indicated that lower device variability may increase the reliability of results.
About AccuTest™
AccuTest-1™ Single Prick Testing Device
- Hardened plastic tines for maximum sharpness ensures precise testing with a single prick.
- Smaller tine lengths and diameters for enhanced precision, offering accuracy while minimizing discomfort for the practitioner and patient.
- AccuTest-1™ is versatile and compatible with both 48-well and 60-well allergen trays.
AccuTest-8™ and AccuTest-10™
- Designed for easy integration with your testing panel needs in 8-head and 10-head models.
- Smaller tine lengths and diameters for enhanced precision, offering accuracy while minimizing discomfort for the practitioner and patient.
- Engineered with enhanced ergonomics for optimal performance.
- Pronounced ribbed design for a secure grip, increased control, and comfort during use.
- Larger top surface area for uniform pressure application to facilitate more consistent and reliable results.
You must observe all the cautions and procedures contained in the package insert for contraindications, intervals relating to drug administration and application of the test. This device is restricted by Federal Law to be used by or under order of a licensed physician or nurse practitioner.
About ALK
ALK is a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,600 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.
For further information please contact:
ALK 800-325 or jay.bates@alk.net
References:
Marcos A Sanchez-Gonzalez; Troy J Grogan; Marvin Smollar; Syed A. A. Rizvi. "Improving allergy testing and diagnosis: impact of skin prick testing intra-head device variability on clinical performance", Journal of Preventive and Complementary Medicine, 2, 2, 2023, 62-68. doi:10.22034/ncm.2023.398971.1085
View original content to download multimedia:https://www.prnewswire.com/news-releases/alk-announces-us-fda-approval-of-new-accutest-allergy-skin-testing-devices-for-optimized-allergy-testing-and-diagnosis-302268823.html
SOURCE ALK, INC.
FAQ
What are the new AccuTest™ allergy skin testing devices approved by the FDA for ALK (AKBLF)?
How do the new AccuTest™ devices improve allergy testing accuracy?
What are the key features of the AccuTest™ allergen well trays?
How does AccuTest™ compare to other FDA-approved skin prick tests?
