FDA announced earlier this week the availability of the draft guidance titled "Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays." This document describes a means by which the HSV serological assay device type may comply with the requirement of special controls for Class II devices.
For manufacturers of HSV Types 1 and 2 serological assays, FDA's document offers recommendations for the types of information and data that should be included in a 510(k) submission. 
The agency says it has "revised the existing guidance by rewriting the method comparison section and the sample-selection inclusion and exclusion criteria section." The revisions "defined and differentiated the required studies and the study populations for the assessment of the safety and effectiveness of the...

BD Diagnostics and Bruker Daltonics Inc. announced an international co-development and co-marketing collaboration that will promote an emerging, integrated approach to bacterial and fungal identification and antimicrobial susceptibility testing. This new approach has the potential to transform how traditional microbiology has been performed for decades.

Through this collaboration, identification of microorganisms will be performed with the Bruker MALDI Biotyper, a mass spectrometry-based proteomic “fingerprinting” system specifically configured for rapid identification of bacteria, yeast and fungi. The MALDI Biotyper is available in a clinical version with IVD-CE mark in Europe and is for research use only (RUO) in the United States, where Bruker intends to seek FDA clearance.

BD and Bruker intend to combine the MALDI Biotyper microbial ID system with automated antimicrobial susceptibility testing on the BD Phoenix Microbiology System. The BD EpiCenter...

Clinical Genomics Pty. Ltd. (Sydney, Australia) and the Garvan Institute of Medical Research (Sydney, Australia) have entered into a license agreement in relation to novel biomarkers discovered by scientists at the Garvan Institute. Under the terms of the agreement, Clinical Genomics obtains worldwide exclusive rights to the Garvan’s proprietary cancer associated methylation DNA biomarkers for the diagnosis and or treatment of colorectal cancer. Clinical Genomics intends to expand its colorectal biomarker research program to evaluate these promising biomarkers in view of formulating a diagnostic test utilizing those biomarkers demonstrating clinical benefit for the early detection of colorectal cancer.
“Through this strategic licensing agreement with the Garvan Institute, we have complemented our existing technology portfolio and enhanced our ability to develop next generation products for diagnosing colorectal cancer at the earliest, most treatable stage,”...

OncoMethylome Sciences announced that it has entered into an agreement with GlaxoSmithKline Biologicals S.A. (GSK) for the potential use of one of its DNA methylation specific PCR biomarkers in GSKs immunotherapy development program. Additional financial details were not disclosed.

OncoMethylome's biomarker is stable, highly accurate, and, unlike many other biomarkers, allows for the analysis of non-invasive tissue samples.

"We are very pleased to enter into this agreement with GSK. This project was initiated in 2007 and is a prime example of how we can bring our considerable regional strengths to bear on global healthcare issues," said Jan Groen, PhD, Chief Executive Officer of OncoMethylome. "Furthermore, this agreement marks an important step for our company in the use of our biomarker with certain immunotherapeutics in development by GSK, and underpins our strategy of leveraging our methylation specific PCR platform in the rapidly emerging field of...