IVDR accreditation for Yourgene QST*R Base assay

Paris, France, and Manchester, UK - 20 February 2025 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international molecular diagnostics company with a broad portfolio of integrated technologies and services, announces that it has received accreditation under the new EU requirements of the In Vitro Diagnostic Regulation ("IVDR") for the Yourgene® QST*R Base assay. The Yourgene® QST*R Base is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.

Yourgene® QST*R Base is a highly multiplexed, single tube assay containing 22 markers for rapid diagnosis of the common autosomal and sex chromosome aneuploidies during pregnancy. For those women identified as being at high risk of carrying a fetus with one of these conditions, chorionic villus sampling (10-12 weeks) or amniocentesis (14-18 weeks) is offered and QST*R Base would then be used by the laboratory. Autosomal markers are used to detect the three most common viable autosomal trisomies: trisomy 21 (Down's syndrome), trisomy 18 (Edwards' syndrome) and trisomy 13 (Patau's syndrome). The chosen markers are highly informative with results obtained in >99% of samples.

IVDR ensures that the Yourgene® QST*R Base assay, which is manufactured for sale in the EU, is assessed against stringent quality, safety and performance requirements. Manufacturers must provide considerable evidence of scientific validity, as well as data demonstrating analytical and clinical performance of the tests. The Yourgene® QST*R Base assay was assessed by British Standards Institution (BSI), an independent conformity assessment body, and was shown to conform to the new regulations.

Lyn Rees, CEO of Novacyt, commented: "This is the third IVDR accreditation for Novacyt which further demonstrates the high quality and accuracy of our products, and our team's ability to navigate the stringent new regulatory environment for in vitro diagnostic tests. Novacyt has a range of tests for the reproductive health lifecycle and the QST*R Base test is complementary to our NIPT tests providing a follow-on confirmatory test after a high risk NIPT result. We are very proud to have developed an assay that provides accurate and reliable results during a stressful time in the pregnancy for expecting parents."