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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Dec 10, 2009


Roche Molecular Systems has launched the cobas 4800 system, which combines CE-marked in vitro diagnostic tests for Chlamydia trachomatis, Neisseria gonorrhoeae, and human papillomavirus with automated sample preparation and real-time PCR.

Roche said that the tests are designed to detect the 14 HPV high-risk genotypes that are "widely accepted to cause cervical cancer and bacterial DNA associated with chlamydia and gonorrhea infections."

In particular, the cobas 4800 HPV test identifies the HPV 16 and HPV 18 genotypes, which are associated with the highest risk for cervical cancer.

The system, which has a throughput of up to 288 HPV tests or 384 CT and NG tests in eight hours, is available in countries that accept CE-marking, Roche said.

BD Diagnostics, a segment of Becton, Dickinson and Company, said this week that it has received clearance from the US Food and Drug Administration to use its ProbeTec Chlamydia trachomatis and Neisseria gonorrhoeae amplified DNA assays with liquid samples collected during routine Pap testing for cervical cancer screening.

The company plans to launch the tests in January 2010 and expects to market them to "large hospitals and reference labs," according to a company spokesman.

BD said that the ProbeTec Qx Amplified DNA Assays are the first to receive FDA clearance for gynecological specimens collected and transported in liquid-based cytology preservative media.

BD's ProbeTec technology is based on strand displacement amplification, or SDA, which is an isothermal process that does not require a thermal cycler to drive the reaction.

The BD ProbeTec Qx Amplified DNA Assays are run on the company's BD Viper System with XTR Technology, an automated processing platform that can provide up to 736 CT/GC results in eight and a half hours, BD said.

Transgenomic has launched its Surveyor Scan KRAS kit, a mutation-detection kit that is based on its proprietary Surveyor Nuclease and Wave HS DHPLC platform.

Surveyor Scan uses a PCR amplification reaction and hybridization to form heteroduplex DNA molecules in samples with KRAS mutations. After a digestion step is performed using Surveyor Nuclease, which cuts the DNA strands at mismatched base pairs, the different-sized pieces of DNA are recognized as additional peaks on a chromatogram when compared to non-mutant DNA.

KRAS mutations are associated with lack of response to therapies directed against the epidermal growth factor receptor in colorectal cancer.

Transgenomic said that it plans to follow the KRAS assay with kits for BRAF, p53, and other cancer pathway gene mutations in "the near future."

The Scan

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