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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

Germline-Targeting HIV Vaccine Shows Promise in Phase I Trial

A National Institutes of Health-led team reports in Science that a broadly neutralizing antibody HIV vaccine induced bnAb precursors in 97 percent of those given the vaccine.

Study Uncovers Genetic Mutation in Childhood Glaucoma

A study in the Journal of Clinical Investigation ties a heterozygous missense variant in thrombospondin 1 to childhood glaucoma.

Gene Co-Expression Database for Humans, Model Organisms Gets Update

GeneFriends has been updated to include gene and transcript co-expression networks based on RNA-seq data from 46,475 human and 34,322 mouse samples, a new paper in Nucleic Acids Research says.

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.