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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Jan 21, 2010


Myconostica said this week that it has launched a new version of its MycAssay Pneumocystis assay product in the European Community and Canada.

MycAssay Pneumocystis is a molecular diagnostic test for use with Cepheid's SmartCycler that detects the fungal pathogen Pneumocystis jirovecii in lower respiratory tract samples.

Pneumocystis jirovecii is typically associated with HIV/AIDS and other immunocompromised patient groups.

The run time for the test is less than two hours and the kit contains sufficient reagents for up to 23 reactions plus positive and negative controls, Myconostica said.

The company said that the updated kit has "improved clinical performance and increased analytical sensitivity."

The company also said this week that Bactus will serve as the exclusive distributor of its products in Sweden and Finland, under a new agreement.

DiaGenic said this week that Ferrer inCode will distribute its blood-based ADtect test for early diagnosis of Alzheimer’s disease.

The agreement gives Ferrer inCode, a biotech subsidiary of Grupo Ferrer Internacional, the exclusive right to market ADtect in Germany, Belgium, the Netherlands, Luxemburg, France, Italy, Spain, Portugal, and Latin America.

ADtect is a blood-based gene expression test that uses real-time RT-PCR to measure the quantity of 96 specific RNA transcripts in blood. It uses an algorithm that analyzes the overall pattern of gene expression to derive a test score. Values above zero are classified as positive and indicate the presence of Alzheimer's disease, while values below zero are classified as negative and indicate the absence of Alzheimer's disease.

ADtect is CE-marked. The company recommends its use "together with other clinical evaluations to confirm the presence or absence of Alzheimer's disease," and notes that it should not be used as a screening test.

The Scan

Guidelines for Ancient DNA Work

More than two dozen researchers have developed new ethical guidelines for conducting ancient DNA research, which they present in Nature.

And Cleared

A UK regulator has cleared former UK Prime Minister David Cameron in concerns he should have registered as a consultant-lobbyist for his work with Illumina, according to the Financial Times.

Suit Over Allegations

The Boston Globe reports that David Sabatini, who was placed on leave from MIT after allegations of sexual harassment, is suing his accuser, the Whitehead Institute, and the institute's director.

Nature Papers on Esophageal Cancer, Origin of Modern Horses, Exome Sequencing of UK Biobank Participants

In Nature this week: genetic and environmental influences of esophageal cancer, domestic horse origin traced to Western Eurasian steppes, and more.