Novel Lateral Flow Point-of-Care Assays Expand Boundaries of Clinical Diagnostics

Genisphere showcased its revolutionary point-of-care technology at AACC last week. The company has adapted its pioneering 3DNA Dendrimer Signal Amplification technology for Lateral Flow (LF) Point-of-Care (POC) assays, providing improved sensitivity and enabling a broad new array of POC tests.

LF assays represent a unique and growing class of POC tests designed to rapidly diagnose patients within clinically actionable timeframes. Genisphere’s 3DNA^® signal amplifiers will enable the commercialization of new LF assays that otherwise could not be launched due to unacceptably low sensitivity and will help test-makers differentiate themselves in the competitive POC testing market, which is flooded with products that are limited by both sensitivity and quantitative accuracy.

These developments build on previous signal amplification capabilities that have been demonstrated in other systems such as ELISA, protein and DNA arrays, as well as Luminex^® assays.

“Genisphere’s game-changing 3DNA^® technology provides an improvement of sensitivity in lateral flow assays that no other system has been able to achieve,” said Jim Kadushin, vice president and chief operating officer, Genisphere. “Genisphere has accomplished its goal of providing a robust and easy-to-use reagent that manufacturers can drop into their existing bioassay platform with very little adaptation and no end user modifications required. We look forward to exploring a range of strategic partnering opportunities.”

Genisphere’s proprietary 3DNA^® Dendrimer technology has delivered up to 64-fold improvements in sensitivity over standard, non-dendrimer assays. With this heightened power of detection, the technology can reduce false negatives and significantly increase the accuracy of otherwise-subjective outcome readings.

The technology will expand the POC market to more sensitive rapid-testing for a wide list of conditions such as infectious diseases, bacterial sepsis, coronary biomarkers, food microbiological testing, and environmental and water testing that are outside the analytical reach of current systems.