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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

Not Yet a Permanent One

NPR says the lack of a permanent Food and Drug Administration commissioner has "flummoxed" public health officials.

Unfair Targeting

Technology Review writes that a new report says the US has been unfairly targeting Chinese and Chinese-American individuals in economic espionage cases.

Limited Rapid Testing

The New York Times wonders why rapid tests for COVID-19 are not widely available in the US.

Genome Research Papers on IPAFinder, Structural Variant Expression Effects, Single-Cell RNA-Seq Markers

In Genome Research this week: IPAFinder method to detect intronic polyadenylation, influence of structural variants on gene expression, and more.