Celera 'fragile X' test improves speed of diagnosing inherited mental retardation

By Elaine Rigoli

Tampa, Fla., March 24 - Celera Genomics announced preliminary data from a feasibility study using its fragile X research test, being developed as part of Celera's alliance with Abbott.

Fragile X syndrome is the most common cause of inherited mental retardation, according to a company news release.

This feasibility study found that the research assay reduced the time to determine normal alleles to one day compared with the current four to seven days using existing in-house methods.

The test had an agreement rate of more than 95% in clinical samples with normal and intermediate size alleles, the release said.

The Celera test, a non-radioactive polymerase chain reaction (PCR) assay, co-amplifies a novel gender-specific gene simultaneously with triplet repeats up to 645 units, the release said.

This study demonstrates that considerable laboratory technician time could be saved by referring only non-normal outcomes for additional tests through PCR-acrylamide gels and Southern blotting, a method of locating a particular sequence of DNA within a complex mixture.

Celera said the test requires minimal hands-on time, is rapid, uses existing instrumentation and fits well into the workflow of its clinical laboratory.

"The research assay has further potential benefits to the process of detecting fragile X syndrome. By using this assay rather than our current methodologies of PCR-acrylamide gels and Southern blotting, potentially 94% fewer autoradiographs could be performed in our laboratory, effectively minimizing the existing problematic issues associated with radioactivity such as cost, accidental spills and disposal, as well as neurotoxicity with acrylamide," said Monique Johnson, a genetics fellow at Oregon Health and Science University in Portland, in a statement.

"Additionally, data for normal individuals would be stored electronically, minimizing the storage of membranes and autoradiographs," she added.

Celera, located in Rockville, Md., develops and commercializes diagnostic products.

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