Contract laboratories looking to enhance their CF testing capabilities can now rely on the IVDR-accredited Yourgene® Cystic Fibrosis Base Assay from Yourgene Health, a Novacyt company. With IVDR Class C certification, this assay adheres to rigorous safety, performance, and quality standards, meeting the needs of labs specializing in genetic testing and clinical diagnostics. Through advanced mutation detection via Amplification-Refractory Mutation System (ARMS) technology, the assay screens for over 50 prevalent cystic fibrosis mutations among European populations, ensuring dependable results for a range of applications, including newborn and carrier screening.
With its accreditation validated by the British Standards Institution (BSI), this assay exemplifies regulatory compliance, making it a trusted asset for contract labs focused on hereditary disorder testing.
Benefits for Contract Laboratories
- Accredited to EU IVDR Standards: Ensures high quality and reliability for CF diagnostics.
- Comprehensive Mutation Screening: Detects 50 common CF mutations, meeting diverse diagnostic needs.
- Validated Accuracy and Consistency: Meets analytical and clinical performance criteria essential for contract testing environments.
- Wide Application Range: Supports carrier and newborn screening as well as specific infertility testing.
- BSI Assessed: Confirmed by an independent standards body, providing a credible solution for contract labs.
The Yourgene Cystic Fibrosis Base Assay supports contract laboratories in delivering compliant, high-quality CF diagnostics for clients across Europe.
This article is an AI generated summary of a published press release provided by Yourgene Health
