Summary: Yourgene Health’s Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards of quality and safety for detecting cystic fibrosis mutations.
Takeaways:
- The Yourgene Cystic Fibrosis Base assay is now IVDR-accredited, meeting stringent EU requirements for safety, performance, and scientific validity.
- The test detects the 50 most common CF mutations using advanced molecular technology, supporting various diagnostic scenarios such as newborn and carrier screening.
- IVDR conformity enhances confidence in the test’s accuracy, positioning it as one of the first IVDR-approved CF tests on the market.
Yourgene Health, an international molecular diagnostics group and part of the Novacyt group of companies, has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene Cystic Fibrosis Base assay.
The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.
IVDR ensures that the Yourgene Cystic Fibrosis Base test, 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 the analytical and clinical performance of the tests.
The Yourgene Cystic Fibrosis Base test was assessed by the British Standards Institution (BSI), an independent conformity assessment body, and was shown to conform to the new regulations,
Impact of Cystic Fibrosis
Cystic fibrosis (CF) has become the most common life-shortening hereditary genetic condition affecting one in 2,500 live births in Caucasians. In the U.K., all newborns are screened for CF as part of the newborn blood spot test. The test is performed within the first three days of a baby’s life and involves pricking the baby’s heel and collecting a few drops of blood on a card. The blood is then tested for CF and other rare conditions.
The Yourgene Cystic Fibrosis Base assay uses amplification-refractory mutation system technology and genetic analyzers to detect point mutations, insertions, or deletions in DNA. The assay is designed with all clinically relevant diagnostic scenarios in mind such as carrier screening, newborn screening, and male factor infertility testing.
The Yourgene Cystic Fibrosis Base test, part of Yourgene’s Reproductive Health portfolio, is used to identify patients with any of the 50 most common CF mutations in the European population.
“This is the second product within the now enlarged Novacyt product portfolio to conform to the new EU IVDR regulations and is one of the first IVDR CF tests on the market,” says Lyn Rees, CEO of Novacyt. “Conformity with IVDR provides clinicians and patients with additional confidence in the high-quality and accuracy of our test which is increasingly becoming an essential test in the detection and diagnosis of CF.”
Further reading: Why Timely Newborn Screenings for Cystic Fibrosis is Critical
Photo: Yourgene
