Quidel recently submitted a 510(k) package to the US Food and Drug Administration for its first molecular diagnostic assay, a real-time PCR-based test for influenza A and B for use on Life Technologies' 7500 Fast Dx platform.
The collaboration will combine microfluidic PCR technology licensed from Caliper Life Sciences and various innovations from Canon's imaging and printing products with sample prep, digital PCR, and sequencing components from UMD researchers.
The company's test, called Detect-Ready, uses real-time PCR to amplify and evaluate multiple gene targets to detect and distinguish between samples containing MRSA, MSSA, and mixed populations of bacteria.
The company said that it has achieved encouraging results in a preclinical study of the assay, and that if clinical trial results are equally positive it will submit the test for US Food and Drug Administration approval by the end of the summer.
InstantLabs said that it has placed 20 beta versions of its portable real-time PCR testing system, including eight in the Middle East, where it sees a rapidly developing market for food testing and infectious disease testing due to the area's large guest worker population.
Nascent firm DevaCell believes that its ScanStream instrument will cost a tenth the price of comparable commercial platforms and save the US healthcare system $5 billion to $10 billion per year by curbing the incidence of hospital-associated infections.