ALK Announces U.S. FDA Approval of New AccuTest™ Allergy Skin Testing Devices for Optimized Allergy Testing and Diagnosis
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.
ALK, un'azienda farmaceutica globale specializzata nella prevenzione, diagnosi e trattamento delle allergie, ha annunciato l'approvazione da parte della FDA per la sua nuova linea di dispositivi per test allergologici AccuTest™. La gamma innovativa di prodotti include:
1. AccuTest-1™: dispositivo per test cutanei a punzecchiatura singola
2. AccuTest-8™ e AccuTest-10™: applicatori multi-testa con rispettivamente 8 e 10 teste
3. vassoi per allergeni AccuTest™ a 48 e 60 pozzetti
Questi dispositivi presentano un'ergonomia migliorata, lunghezze e diametri degli aghi più piccoli per una maggiore precisione e comfort del paziente. I vassoi per allergeni dispongono di un meccanismo di chiusura ermetica e di un fondo in gomma antiscivolo per stabilità. Uno studio recente suggerisce che la minore variabilità dei dispositivi AccuTest™ possa aumentare l'affidabilità dei risultati rispetto a due test cutanei a punzecchiatura attualmente approvati dalla FDA.
ALK, una empresa farmacéutica global enfocada en la prevención, diagnóstico y tratamiento de alergias, ha anunciado la aprobación de la FDA para su nueva línea de dispositivos de pruebas cutáneas de alergia AccuTest™. La gama de productos innovadores incluye:
1. AccuTest-1™: dispositivo para prueba de punción cutánea única
2. AccuTest-8™ y AccuTest-10™: aplicadores de múltiples cabezales con 8 y 10 cabezales, respectivamente
3. bandejas de alérgenos AccuTest™ de 48 y 60 pocillos
Estos dispositivos cuentan con una ergonomía mejorada, longitudes y diámetros de las púas más pequeños para mayor precisión y comodidad del paciente. Las bandejas de alérgenos tienen un mecanismo de bloqueo hermético y una base de goma antideslizante para estabilidad. Un estudio reciente sugiere que la menor variabilidad de los dispositivos AccuTest™ puede aumentar la fiabilidad de los resultados en comparación con dos pruebas de punción cutánea actualmente aprobadas por la FDA.
ALK는 알레르기 예방, 진단 및 치료에 중점을 둔 글로벌 제약 회사로, 새로운 AccuTest™ 알레르기 피부 검사 장치 라인에 대한 FDA 승인을 발표했습니다. 이 혁신적인 제품군에는 다음이 포함됩니다:
1. AccuTest-1™: 단일 피부 찔림 검사 장치
2. AccuTest-8™ 및 AccuTest-10™: 각각 8개 및 10개의 헤드를 가진 다중 헤드 어플리케이터
3. 48개 및 60개 웰 알레르겐 트레이 AccuTest™
이 장치는 향상된 인체공학, 더 작아진 가시 길이와 직경으로 정확성과 환자 편안함이 높아졌습니다. 알레르겐 트레이는 공기가 차단되는 잠금 장치와 안정성을 위한 미끄럼 방지 고무 바닥을 갖추고 있습니다. 최근 연구에 따르면 AccuTest™의 낮은 장치 변동성이 현재 FDA 승인을 받은 두 가지 피부 찔림 검사와 비교할 때 결과의 신뢰성을 높일 수 있다는 것을 시사합니다.
ALK, une entreprise pharmaceutique mondiale spécialisée dans la prévention, le diagnostic et le traitement des allergies, a annoncé l'approbation de la FDA pour sa nouvelle ligne de dispositifs de tests cutanés d'allergie AccuTest™. La gamme de produits innovants comprend :
1. AccuTest-1™ : dispositif de test cutané par piqûre unique
2. AccuTest-8™ et AccuTest-10™ : applicateurs multi-têtes avec respectivement 8 et 10 têtes
3. Plateaux d'allergènes AccuTest™ à 48 et 60 puits
Ces dispositifs sont dotés d'une ergonomie améliorée, de longueurs et de diamètres d'aiguilles plus petits pour une précision et un confort accrus pour le patient. Les plateaux d'allergènes disposent d'un mécanisme de verrouillage hermétique et d'un fond en caoutchouc antidérapant pour la stabilité. Une étude récente suggère que la variabilité inférieure des dispositifs AccuTest™ pourrait augmenter la fiabilité des résultats par rapport à deux tests de piqûre cutanée actuellement approuvés par la FDA.
ALK, ein globales Pharmaunternehmen, das sich auf die Prävention, Diagnose und Behandlung von Allergien konzentriert, hat die FDA-Zulassung für seine neue AccuTest™-Reihe von Allergie-Hauttestgeräten angekündigt. Die innovative Produktreihe umfasst:
1. AccuTest-1™: Gerät für Einzel-Hautstichtests
2. AccuTest-8™ und AccuTest-10™: Mehrkopfapplikatoren mit 8 bzw. 10 Köpfen
3. 48- und 60-Well-Allergen-Trays AccuTest™
Diese Geräte verfügen über eine verbesserte Ergonomie, kleinere Stiftlängen und -durchmesser für erhöhte Genauigkeit und Patientenkomfort. Die Allergen-Trays sind mit einem luftdichtem Verriegelungsmechanismus und einem rutschfesten Gummiboden für Stabilität ausgestattet. Eine kürzlich durchgeführte Studie legt nahe, dass die geringere Gerätevariabilität von AccuTest™ die Zuverlässigkeit der Ergebnisse im Vergleich zu zwei derzeit von der FDA genehmigten Hautstichtests erhöhen könnte.
- 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
- 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
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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?
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