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Dx Focus Dec 9, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News

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Gen-Probe said this week that its Prodesse subsidiary has received US Food and Drug Administration clearance for its ProAdeno+ assay for qualitative detection of human adenovirus.

The test uses multiplex real-time PCR to detect human adenovirus DNA in nasopharyngeal specimens obtained from people exhibiting signs and symptoms of acute respiratory infection. It can detect, but not differentiate among, adenovirus serotypes 1-51, Gen-Probe said.

The company also said that the new assay uses the same sample type as Prodesse's other respiratory infectious disease tests, so a single sample can be tested with any combination of the products. Test results can be obtained in as little as three hours, as opposed to up to two weeks with culture-based methods.

Gen-Probe noted that the test is the third Prodesse product cleared by FDA since Gen-Probe acquired the firm a little more than a year ago.


Myconostica this week presented data demonstrating the ability of its real-time PCR-based MycAssay Aspergillus to improve diagnosis of Aspergillus bronchitis in patients with cystic fibrosis.

At the British Thoracic Society meeting in London last week, scientists from the company reported that when used on cystic fibrosis sputum samples collected from 117 adults attending the Manchester Adult Cystic Fibrosis unit, MycAssay Aspergillus was 260 percent more sensitive than current culture-based methods.

The company also noted that test sensitivity is improved dramatically when the test is combined with Myconostica’s fungal DNA extraction system, MycXtra, and pretreated with dithiothreitol and sonication; and that PCR results were negative in 5 of 11 patients on antifungal treatment, suggesting that PCR might be the best way to assess whether antifungal therapy is working.

MycAssay Aspergillus this year received the CE Mark for detecting Aspergillus spp. DNA in serum and respiratory samples.


Warnex Medical Laboratories and Epigenomics said this week that Warnex has launched a Septin9 blood-testing service for colorectal cancer in Canada.

Warnex's Septin9 test uses real-time PCR and is based on Epigenomics' Septin9 biomarker and DNA methylation technologies. Warnex obtained non-exclusive rights to the technologies in May 2010.

The companies noted that Warnex is the first laboratory to offer Septin9 testing in Canada.

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.