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Dx Focus Jul 1, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Abbott has received 510(k) clearance from the US Food and Drug Administration for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae assay and the Abbott m2000 real-time PCR system, which are required to be used together as a system to detect CT/NG from multiple specimen types including urine, urethral, vaginal and endocervical swabs.

Abbott said that the FDA also cleared its Multi-Collect Specimen Collection Kit for the collection and room-temperature transportation of multiple samples, including urine samples and endocervical, vaginal, and male urethral swab specimens, in one collection device.

"Because many people with chlamydia are co-infected with gonorrhea, it's important to test for both diseases simultaneously," said Klara Abravaya, senior director of research and development at Abbott Molecular, in a statement.

Response Genetics has expanded its ResponseDX: Lung genetic test panel to detect the presence of EML4-ALK gene variants in lung cancer patients.

EML4-ALK fusion genes are present in approximately 4 percent of tumors from patients with non-small cell lung cancer and can predict poor response to EGFR inhibitors.

The company said that its proprietary PCR-based assay can rapidly detect and identify nine known fusion gene variants in archival tissue.

ResponseDX: Lung also detects the expression of ERCC1, thymidylate synthase (TS), EGFR, and the active subunit of ribonucleotide reductase (RRM1), as well as mutations in EGFR and KRAS.

The Scan

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.

Genome-Wide Analysis Sheds Light on Genetics of ADHD

A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder.

MicroRNA Cotargeting Linked to Lupus

A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus.

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.