OGT Initiates Clinical Trial of New Array-Based NIPT
News Nov 04, 2014
Oxford Gene Technology (OGT) has announced that it is initiating a clinical trial of a new microarray-based non-invasive prenatal test (NIPT) for Down’s syndrome.
OGT 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 utilize 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.
John Anson, Executive Vice President R&D, OGT said: “Non-invasive prenatal testing has the potential to more accurately identify the need for additional invasive testing of high-risk pregnancies. We have adapted a previously invasive methodology into a non-invasive test to detect chromosomal abnormalities; our microarray-based approach requires only a small sample of maternal blood instead of an invasive amniocentesis procedure. Our hope is that this test, once it is clinically validated, will be widely adopted by clinical testing laboratories to ensure more pregnant women and their clinicians can access this highly sensitive, rapid and safe procedure.”
OGT 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). This is a significant improvement to the current standard of care, the combined test.
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.
John Anson will be presenting OGT’s proprietary NIPT methodology at the forthcoming Advances in Prenatal Molecular Diagnostics conference in Boston, MA, USA on Thursday 6 November. The presentation is entitled ‘Fetal CNV Detection Directly from Circulating Cell-Free DNA in Maternal Blood Using a Modified Array CGH Approach’.