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


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

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.