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.