Among recent regulatory approvals for bio-optics products are a second FDA 501(k) clearance for Monteris Medical's (Minneapolis, MN) MRI-guided laser ablation device for brain tumors and other lesions. Called NeuroBlate, the device includes a surgical laser for ablation of diseased brain tissue, with updated visualization provided by active MRI. A first-generation version of the device has been available in U.S. hospitals since 2010. NeuroBlate supports surgical decision-making during brain operations and provides post-procedure confirmation of the effects of the thermal therapy.
The HER2 IQFISH pharmDx fluorescence in situ hybridization (FISH) assay, which could reduce cancer evaluation from 2 days to 3.5 hours, is the first system of its kind to receive FDA approval. Marketed by Dako (Glostrup, Denmark), an Agilent Technologies company, the system promises to enable faster, targeted cancer treatments.
IQFISH helps to assess patients for whom treatment with trastuzumab (a monoclonal antibody) is being considered. It can also support identification of HER2 gene status with accuracy and speed. The HER2 gene encodes a protein called human epidermal growth factor receptor 2 (HER2), which promotes cell growth and aggressiveness in one out of five breast cancers, which are less responsive to hormone treatment.
Finally, Genalyte's (San Diego, CA) Maverick multiplexed detection system, which simultaneously analyzes multiple antibodies and other proteins from a single small sample, is now CE-marked in Europe for research use. The system uses a silicon chip containing arrays of photonic ring sensors that simultaneously analyze multiple antibodies and other proteins. Its one-step workflow is said to deliver results in as little as 15 minutes from small-volume samples of many types.—Barbara G. Goode