Yourgene’s cystic fibrosis assay achieves IVDR certification
The CE-marked assay provides fast and simple real-time PCR-based detection of SARS-CoV-2 in RNA isolated from the patient samples. Reverse transcription and real-time PCR are performed in one step, so that only one reaction is required per sample.
The test provides high sensitivity due to simultaneous detection of two defined target sequences in the ORF1ab and N genes of the viral genome. The variants alpha (B.1.1.7 lineage), beta (b.1.351 lineage), gamma (P.1 lineage) and delta (B1.617.2 lineage) can be reliably detected.
The test contains an internal amplification control, which serves as an inhibition and extraction control. A SARS-CoV-2 positive control provided in the test kit is analysed as an external control in every test run ensuring dependable results. The complementary EURORealTime Analysis software provides fully automated and standardised evaluation and documentation of results, including all control results. Comprehensive automation options for sample preparation, PCR setup and PCR performance are available.
Manchester-based molecular diagnostics company Yourgene Health has secured In Vitro Diagnostic Regulation (IVDR) certification for its Cystic Fibrosis Base assay, marking a significant regulatory milestone for the Novacyt group subsidiary.
The Class C in vitro medical device, designed for molecular laboratory use, underwent rigorous assessment by the British Standards Institution (BSI) to meet the EU’s new IVDR requirements. This certification process demanded extensive documentation of scientific validity alongside analytical and clinical performance data.
The assay employs amplification-refractory mutation system technology coupled with genetic analysers to detect point mutations, insertions, and deletions in DNA sequences. It has been specifically developed to identify the 50 most prevalent cystic fibrosis mutations found in European populations.
Cystic fibrosis, which affects approximately 1 in 2,500 Caucasian live births, represents the most common life-limiting inherited genetic condition. The assay’s versatility allows its application across multiple clinical scenarios, including carrier screening, newborn screening programmes, and male factor infertility testing.
In the UK context, the test complements existing newborn screening protocols, where blood spot testing is performed within 72 hours of birth to screen for cystic fibrosis and other rare conditions. The certification is particularly timely given the expanding global market for CF testing, notably in Australia, where recent healthcare policy changes have established nationwide reimbursement pathways for CF screening during preconception and early pregnancy.
Commenting on the certification, Novacyt CEO Lyn Rees noted that this represents the group’s second product to achieve IVDR conformity, positioning it among the first IVDR-certified CF tests available in the market.
The IVDR certification provides additional validation for the assay’s quality and accuracy, particularly significant as CF testing becomes increasingly essential in diagnostic protocols. This regulatory achievement looks set to strengthen the test’s position both within the EU market and internationally.
For more information, visit: https://yourgenehealth.com/our-products/assays-and-applications/reproductive-health/cystic-fibrosis
Digital issue: Please click here for more information
