OGT initiates clinical trial of array-based non-invasive prenatal test

Oxford, UK – 27 October 2014. OGT, the molecular genetics company, today announced 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 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.

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 2019¹.

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’. 

References

1. Transparency Market Research: Non-Invasive Prenatal Testing (NIPT) Market 2013 - 2019

About OGT

OGT, a Sysmex Group company, is a leading global provider of clinical and diagnostic genomic solutions that are created for scientists by scientists - including CytoCell^®, CytoSure^® and SureSeq™ ranges of FISH, microarray and NGS products. The company is dedicated to creating products that enable researchers and clinical decision makers to reach the right care decisions for each patient, every time. OGT strives to unlock the future of genetic clinical care with a commitment to working in partnership with its customers - not only by sharing its expertise of 25 years at the forefront of genetic endeavour, but also by working closely with scientists to understand their unique challenges, and to customise its approach to meet their exact needs. Dedicated to improving clinical care, OGT believes that through partnership—together—we’ll achieve more.

For more information on the Company, please visit our website at ogt.com

CytoSure^®, SureSeq™ and myProbes^®: For Research Use Only, not for use in diagnostic procedures. CytoCell: Some products may not be available in your region.

About Sysmex Corporation

Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 50 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for cell, gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, the Middle East, Africa, China and Asia Pacific and employs more than 9,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange.

For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.