FDA Clears New Rapid Clinical Laboratory Test for Market that Reduces Time-to-Answer for Bloodstream Infections to Two Hours

Nanosphere’s Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) gives pathologists and clinical laboratory managers a new tool in the diagnosis of septicemia

One of the more challenging diseases to diagnose and treat is septicemia. Traditional microbiology methods typically require two or three days before an accurate diagnosis can be made. Now there is news of a rapid test for bloodstream infections that can allow a hospital clinical laboratory to deliver an answer to physicians in as little as two hours.

It was just last week when the Food and Drug Administration LINK (FDA) granted a de novo petition to allow Nanosphere, Inc., of Northbrook, Illinois, to market its Gram Positive Blood Culture Nucleic Acid Test (BC-GP). This assay is design to be run on Nanosphere’s Verigene automated system. Because the time-to-answer is as little as two hours, this diagnostic technology has the potential to trigger swift changes in the current standard of care for diagnosing and treating blood infections.

Aptamer-Based Blood Protein Detection Technology May Soon Be Used By Medical Laboratories in Tests for Cancer, Diabetes, and Other Diseases

Researchers believe that clinical laboratory assays that use aptamers would have multiple advantages when compared to diagnostic tests utilizing anti-bodies

New diagnostic technology has been developed that has the potential to accurately detect such diseases as cancer and diabetes, even when the patient is pre-symptomatic. Not only would medical laboratory tests using this technology be low cost and portable, but some experts think that diagnostic assays using this technology could make it through the regulatory process and be cleared for clinical use in just five years or less.

This highly-sensitive diagnostic technology is able to detect specific proteins in human blood. It was developed by a research team at the University of Toledo in Ohio. Last fall, they published their findings in the Optical Society’s (OSA) open-access journal, Biomedical Optics Express.