Homeland Security validate biothreat assay

PositiveID Corporation, a developer of medical technologies, clinical diagnostics and biothreat detection, announced on Thursday that the Department of Homeland Security has validated the performance of the company's Multiplex BioThreat Assay.
The DHS Science and Technologies division used and funded an in-house blind study for the validation. The PSIDMBA is the first commercially available MBA for the detection of up to six biothreat organisms recognized as Category A and B threats by the Centers for Disease Control and Prevention.
The PSIDMBA was developed over a five year period by MicroFluidic Systems, PositiveID's wholly owned subsidiary. The PSIDMBA tests for Bacillus anthracis, Yersinia Pestis, Burkholderia pseudomallei, Variola major, Burkholderia mallei and Francisella tularensis. It is also customizable to meet particular customer needs and it is the first in a series of food and environmental pathogen assays expected to be available.
The blind assay validation study was completed successfully with over 150 competing natural occurring strains, near-neighbors and environmental samples. The samples were tested in triplicate with 100 percent agreement achieved for all positives and negatives at a limit of detection equivalent to or better than similar assays performed in a singleplex format. The PSIDMBA was evaluated in real condition environments for a period of one year without any false positive results.
"Having worked in the field of biodefense and assay development for the last 10 years, I believe the PSIDMBA achieves better performance and higher cost savings than any other assay currently on the market," Lyle Probst, the senior director of programs at MFS and the co-developer of the assay, said. "In order to assess the assay's ability to detect unknown samples, our team challenged it in triplicate against a series of blind samples provided by DHS. Our results indicate that the multiplex assay was strain specific and produced no false positives or negatives when challenged with in house gDNA collections and DHS provided panels. Also, these results were achieved with a limit of detection that is state-of-the-art and equivalent or better than those achieved with in singleplex fashion."