Sequenom to Begin Clinical Assessment of Noninvasive Screening Technology for Down Syndrome
News Jan 24, 2008
Sequenom, Inc. has announced the approval of a protocol by the Institutional Review Board (IRB) at San Diego-based Sharp HealthCare, clearing the way to commence patient enrollment in a screening study to clinically assess the Company's noninvasive cell free fetal nucleic acid SEQureDx™ Technology for the detection of fetal aneuploidy, including Down syndrome, using a laboratory developed test (LDT).
More than 2.7 million pregnancies are evaluated annually in the United States to assess the risk of Down syndrome by various screening methods, which are comprised of surrogate serum markers in combination with ultra-sonographic methods. These risk assessment protocols result in the referral of approximately 5% of normal pregnancies to be screened through invasive procedures, such as amniocentesis, to help rule out the chances of an affected pregnancy for Down syndrome.
Sequenom's SEQureDx Technology, to be evaluated in this screening study, provides a direct genetic assessment of Down syndrome using a noninvasive maternal blood sample collected in the first or second trimester of pregnancy.
The expected benefits of this approach are to improve current detection rates, while reducing the number of patient referrals (false positives) to the invasive procedures and fetal losses due to the procedures, which are currently employed in prenatal screening programs throughout the U.S.
"This clinical assessment represents an important milestone in our prenatal genetic testing development program and keeps us on track with our plan to introduce an LDT for Down syndrome in late 2009," said Harry Stylli, Ph.D., Sequenom's President and Chief Executive Officer. "Our SEQureDx Technology-based noninvasive screening method, if verified, could revolutionize Down syndrome prenatal screening."
"Sequenom's technology for Down syndrome screening offers great promise for how we manage our obstetric population within the Sharp HealthCare system and the nation. It will greatly improve the quality of prenatal screening and, ultimately, will reduce the need for invasive prenatal diagnosis - a significant source of anxiety for pregnant women," said Allan Bombard, MD, a reproductive geneticist with more than two decades of experience in the field of prenatal diagnosis, who serves as a Medical Director at Sharp and is the principal investigator of the study.
Domainex Appoints Dr Bodo Spori as Head of Business Development for EuropeNews
Domainex Ltd, a privately-owned drug discovery services company, is pleased to announce the appointment of Dr Bodo Spori as Head of Business Development for Europe.READ MORE
New Drug Compounds Help Prevent Hearing LossNews
Researchers from St. Jude Children's Research Hospital have discovered that inhibiting an enzyme called cyclin-dependent kinase 2 (CDK2) protects mice and rats from noise- or drug-induced hearing loss. The study suggests that CDK2 inhibitors prevent the death of inner ear cells, which has the potential to save the hearing of millions of people around the world.READ MORE
Empowering Women in Technology Key to Boosting UK EconomyNews
A new report launched at London Stock Exchange for International Women’s Day, reveals the critical role women play in driving economic growth across the UK, with detailed research on 1,279 women-led companies showing a total contribution of £25.9 billion in revenue to the UK economy.READ MORE
Comments | 0 ADD COMMENT
6th Annual Congress on Biology and Medicine of Molecules
Sep 17 - Sep 18, 2018
World Congress on Pathology and Laboratory Medicine
Sep 10 - Sep 11, 2018
World Congress on Advances in Addiction Science and Medicine
Sep 24 - Sep 25, 2018
10th International Conference on Mass Spectrometry and Chromatography
Oct 08 - Oct 09, 2018