Features | Partner Sites | Information | LinkXpress
Sign In
RANDOX LABORATORIES
AB Sciex
SEEGENE

Lab Prepares Launch of Trisomy 21 Diagnostic Test

By Labmedica International staff writers
Posted on 23 Aug 2010
A new 650-m2 laboratory will launch the Trisomy 21 (T21) diagnostic test; the launch is planned for the latter half of the year 2011.

The lab will perform validation for Sequenom's (San Diego, CA, USA) T21 noninvasive Down syndrome test. Ian Clements, senior director of the company's investor relations said that samples are currently being collected for a clinical study. About 4,000 samples will be run at the new facility in connection with the final validation of the T21 test.

The clinical trial is being led by scientists at the Women and Infants Hospital (Providence, RI, USA), which is affiliated with Brown University (Providence, RI, USA). The test is sensitive enough to identify fetal DNA circulating in the pregnant woman's blood.

Sequenom has a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited lab, the Sequenom Center for Molecular Medicine, which runs the company's cystic fibrosis and SensiGene fetal Rhesus D genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility. Those tests are run on Sequenom's MassArray technology, whereas the T21 test will run on sequencing technology.

"This is basically an expansion of our lab network," remarked Mr. Clements. "The core of our sequencing expertise and knowledge is here in San Diego, hence it made sense to expand our network and build a CLIA lab here."

Sequenom has a CLIA-certified and CAP-accredited lab, the Sequenom Center for Molecular Medicine, which runs the company's cystic fibrosis and SensiGene fetal Rhesus D genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility.

These tests are run on Sequenom's MassArray technology, whereas the T21 test will run on sequencing technology.

Sequenom anticipates getting CLIA certification and CAP accreditation for the San Diego lab in Q4 2010, he added.

Related Links:

Sequenom
Women and Infants Hospital
Brown University



PURITAN MEDICAL
ADVANCED INSTRUMENTS
GREINER-BIO-ONE
BioConferenceLive

Channels

Genetic Tests

view channel
Image: The QuantiTect Reverse Transcription Kit (Photo courtesy of Qiagen)

Blood Tests Predict Risk of Sudden Cardiac Death

A simple blood test can predict a person's risk for sudden cardiac death, enabling physicians to quickly and accurately assess a patient's need for an implantable cardiac defibrillator (ICD).... Read more

Hematology

view channel

Blood Donations Screened for Viruses Using Multiplex Assay

A global healthcare company was chosen to partner the Japanese Red Cross (JRC; Tokyo, Japan) for nucleic acid screening of the nation's blood supply. Under the terms of the 7-year agreement, the healthcare company, Grifols (Barcelona, Spain) will provide the JRC with its newest automation platform, the Procleix Panther... Read more

Pathology

view channel

Gene Profile Predicts Risk of Bladder Cancer Recurrence

A genomic study has pinpointed several markers that identify bladder cancer patients at risk of recurrence and that may be indicators of overall survival status. Nearly half of patients with bladder cancer experience recurrences, so reliable predictors of this recurrent phenotype are needed to guide surveillance and treatment.... Read more

Industry News

view channel

Beckman Coulter and hc1.com Enter Strategic Partnership for Innovative Healthcare Cloud System

The diagnostics division of Beckman Coulter (Brea, CA, USA) and hc1.com (Indianapolis, IN, USA) have announced a partnership to bring an innovative healthcare cloud-technology system to clinical laboratories. The system, hc1.com's "Healthcare Relationship Cloud," helps turn large amounts of clinical data into actionable... Read more
 
Copyright © 2000-2014 Globetech Media. All rights reserved.