Direct carrier detection
by in situ suppression hybridization with cosmid clones of the Duchenne/Becker muscular dystrophy locus.
Osmetech has a strong patent portfolio and markets FDA 510(k) cleared first- and second-generation electrochemistry-based array systems, the eSensor(R) 4800 platform and the eSensor(R) XT-8 platform, presently available for Cystic Fibrosis Carrier Detection
and Warfarin Sensitivity testing, respectively.
in Duchenne muscular dystrophy: assessment of the effect of age on detection-rate with serum-creatine-kinase-activity.
Osmetech's decision to purchase the popular Pilgrim software closely follows the FDA 510(k) approval Osmetech secured earlier this year for its e-Sensor(R) electrochemistry-based array system for cystic fibrosis carrier detection
Osmetech has rights to a strong portfolio of over 200 issued and pending patents and has launched its first generation eSensor 4800 system, an electrochemistry-based array system, together with an FDA cleared in vitro diagnostic test for Cystic Fibrosis carrier detection
Osmetech has rights to a portfolio of over 200 issued and pending patents and has launched its first generation eSensor 4800 platform, an electrochemistry-based array system, together with an FDA cleared in vitro diagnostic test for Cystic Fibrosis carrier detection
for the heterozygous state proved to be more technically challenging because the SMA region is characterized by the presence of many repeated elements.
Mr White said: "We are delighted with the initial response from customers following the FDA clearance of the product and have a number of shipments planned to both existing customers, who are currently running Cystic Fibrosis Carrier Detection
tests using our first generation platform, and new customers.
The CF Complete test will help experts address difficult clinical cases and provide carrier detection
and prenatal diagnosis for CF families with previously unidentified cystic fibrosis mutations," said Lucia L.