Date: 2014-10-27
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trialmicroarray-based non-invasive prenatal test (NIPT) for Down’s syndrome
Company: Oxford Gene Technology (UK)
Product: microarray-based non-invasive prenatal test (NIPT) for Down’s syndrome
Action
mechanism: The company has developed proprietary microarray technology which has significant advantages over next generation sequencing (NGS). Time to result is reduced from up to ten days to less than three days and the cost of setting up and running the test is considerably lower. As a simple microarray product rather than a service offering, clinical laboratories will, for the first time, be able to utilise existing microarray equipment to offer in-house NIPT. The methodology includes a combination of novel sample preparation procedures, dedicated array design and user-friendly analysis software to ensure simple interpretation of results by clinicians.
Disease: Down’s syndrome/Trisomy 21
Therapeutic area: Genetic diseases - Diagnostic
Country:
Trial details:
Latest
news: * On October 27, 2014, Oxford Gene Technology, a UK molecular genetics company, announced it is initiating a clinical trial of a new microarray-based non-invasive prenatal test (NIPT) for Down’s syndrome. The company has successfully completed a pre-clinical trial of the test using 200 samples from three independent sample sets across two different sites, and achieved exceptionally high sensitivity and specificity for the detection of Trisomy 21 (Down’s syndrome). The Company is now initiating a larger clinical study to support the launch of a CE-marked product. In addition to detecting Trisomy 21, it is expected that in the future the technology will also identify other chromosomal aneuploidies and microdeletions. The global market for NIPT is growing rapidly; it has been projected to reach approximately $3.6 billion by 2019.
