Biotechnology company Signal Diagnostics (SDx) and parent Fluoresentric announce the issuance of patent US Patent Application No. 12/058,627, system and method for high-resolution analysis of nucleic acids to detect sequence variations, which is a breakthrough technology of key past limiting test elements: speed, accuracy and simplicity.

The SDx analysis technology speeds up, simplifies and allows for the accurate detection of drug-resistant tuberculosis (TB). The SDx patented analysis method produces a TB drug resistance profile in a few hours, whereas current molecular methods take days or weeks to produce a similar result.

TB is a devastating disease with more than 15 million active cases and more than nine million new active cases per year. The World Health Organization (WHO) 2006 report stated: “1.7m people die from TB each year many because the infection goes undiagnosed, or is diagnosed too late to be cured.” No test is commercially available to rapidly detect which first-line antibiotics will treat the disease effectively until now. There is a large unmet medical need that contributes to the large number of yearly deaths.

TB is caused by an infection with mycobacterium tuberculosis that has become active. If diagnosed early, there are several antibiotics available to treat and suppress the contagious infection. A critical problem is that a large percentage of TB infection strains exist and are resistant to a subset of the first-line antibiotics; these are termed multi-drug resistant-TB (MDR-TB) infections.

The SDx patented method can be used with several single detection or multiple automated sample analysis platforms. Current molecular techniques require multiple instruments to perform the same scale of testing or extensive data analysis to produce a drug resistance profile for potential antibiotics.

SDx is dedicated to advancement of world healthcare standards through the development of rapid and accurate molecular tests to diagnose disease and drug resistance. SDx and FL companies have developed novel technologies that facilitate the rapid differentiation between ‘normal’ DNA sequences and ‘mutated’ sequences associated with disease or drug resistance.

This technology has myriad potential applications, including multiple drug-resistant tuberculosis, chloroquine-resistant malaria, certain human cancers, protease-resistant HIV, avian flu and more.

SDx is seeking partners to commercialize this novel patented technology.