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Dx Focus Oct 27, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Seegene this week announced the commercial availability outside of the US of the Anyplex II RV16 detection assay, the second real-time qPCR assay based on the company's TOCE technology.

Anyplex II RV16 is a multiplex real-time PCR test that can simultaneously detect 16 of the most common respiratory viruses from a wide range of specimen types, such as nasopharyngeal aspirates and swabs or bronchoalveolar lavages.

Respiratory viruses covered by the assay are: influenza A, influenza B, respiratory syncytial virus A, respiratory syncytial virus B, adenovirus, metapneumovirus, coronavirus 229E, coronavirus NL63, coronavirus OC43, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus A/B/C, enterovirus, and bocavirus 1/2/3/4.

Seegene said that the test is designed to run on any real-time PCR instrument and has a turnaround time of less than four hours. The test is currently unavailable in the US.

Iris International this week announced that its Iris Molecular Diagnostics subsidiary has received ISO 13485:2003 certification and CE Mark for its NADiA ProsVue prognostic cancer test.

NADiA stands for nucleic acid detection immunoassay, a method that combines immunoassay and real-time PCR and can detect proteins with femtogram/mL sensitivity. NADiA ProsVue determines the rate of change of serum total prostate specific antigen and is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying patients at reduced risk for prostate cancer recurrence for the eight-year period following prostatectomy.

The test received 510(k) clearance from the US Food and Drug Administration in September 2011.

The Scan

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.

Duke University Team Develops Programmable RNA Tool for Cell Editing

Researchers have developed an RNA-based editing tool that can target specific cells, as they describe in Nature.

Novel Gene Editing Approach for Treating Cystic Fibrosis

Researchers in Science Advances report on their development of a non-nuclease-based gene editing approach they hope to apply to treat cystic fibrosis.

Study Tracks Responses in Patients Pursuing Polygenic Risk Score Profiling

Using interviews, researchers in the European Journal of Human Genetics qualitatively assess individuals' motivations for, and experiences with, direct-to-consumer polygenic risk score testing.