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GlobalData Release: In Vitro Diagnostics and Weapons of Mass Destruction


8/31/2012 10:54:28 AM

LONDON, UK (GlobalData), 31 August 2012 The decision of Idaho Technology Inc. (ITI) to rebrand itself Biofire Diagnostics Inc. on August 28th once again draws attention to the niche diagnostics companies that have emerged since 2001 to support the needs of the Homeland Defense community in response to intelligence-lead biological warfare threats, perceived pandemic disease threats, and the inter-relationship between traditional clinical diagnostics and biodefense. The detection and identification of deliberately disseminated pathogens and biological toxins utilize similar technologies to those already used in clinical in vitro diagnostics, such as immunoassay or the Polymerase Chain Reaction (PCR). While there are clearly different specific needs, both the biodefense and clinical diagnostics markets have common requirements.

In recent years, governmental biodefense budgets have seen a reduction in spending by the traditional major players. However, recent pronouncements by the US and French governments on the developing situation in Syria, specifically in relation to Syria’s use of weapons of mass destruction – including biological weapons – once again raises the profile of biodefense.

ITI, founded in 1990, developed a novel rapid PCR platform, the now ubiquitous Light PCR system, subsequently licensed to Roche Diagnostic. Idaho Technologies gained prominence after securing the 2003 Joint Biological Agent Identification and Diagnostic System (JBAIDS) contract with the US Department of Defense (DoD), providing a field-deployable multiplexing PCR system capable of identifying a range of biological threat agents. The ITI JBAIDS device is one of the most widely used mobile PCR platforms for homeland security today, alongside a range of commercially available ITI biosurveillance products: the RAPID family, and the RAZOR-EX.

Idaho Technology has signaled a desire to move more into the clinical diagnostics segment, with the development of its FilmArray system, providing a completely self-contained and automated multiplexing PCR system (able to identify up to 20 targets), with panels for Respiratory Infections (RP, 510(k) FDA cleared, CE marked), Blood Culture (BCID, currently entering clinical trials, expected to be commercially available in the US/Europe in early 2013), and Gastro-Intestinal Infections (GI, expected to enter clinical trials early 2013, with commercial availability in 2014), as well as a Biological Threat panel.

According to statements issued by Biofire Diagnostics, in addition to the benefits for the field user, hospital researchers have pointed out the additional cost-saving benefits of the FilmArray System. By reducing actual hands-on time to four minutes and with a turnaround of 65 minutes, a single Film Array instrument can improve laboratory throughput, with seven different clinical samples being analyzed on a single instrument within one eight-hour shift. While these instruments have clear clinical benefits, their development would have been less likely without the specific field testing requirements for portable biodefense instrumentation.

The rebranding exercise may be part of an attempt to separate the biodefense business from the emerging clinical diagnostics business, given that the former does impose significant restrictions on the sale of products, as well as to establish a presence in new markets, in response to a fickle defense market.

Biofire Diagnostics is not the only technology company with an eye on both the clinical and biodefense markets. The most recent edition of the Chemical, Biological, Radiological Technology Survey provides a snapshot of the current and future offerings, with the next survey due in 2013. Most of the providers are also major participants in the clinical diagnostics market, and many of the products are modifications of existing commercially available products. ‘Traditional’ providers of laboratory and clinical instrumentation continue to secure funding to develop new platforms aimed at a biodefense application. For instance, in August 2012, Luminex was awarded an $11m contract by the Defense Threat Reduction Agency to develop a portable device for the detection of patient bio-markers (DNA and proteins) for Systemic Inflammatory Response Syndrome (SIRS). Although aimed principally at providing a rapid diagnostic tool for soldiers who have suffered a trauma in the field (e.g. infection by a biological threat agent), there are potential benefits for the general diagnosis of SIRS, and the targeting of relevant therapies.

Identification and verification of stockpiles, as well as measures to protect survey personnel, will likely continue to utilize dual-use diagnostic platform technologies from companies including Biofire and Luminex. The continued future demand for highly sensitive, high-specificity and reliable biodetection instruments for use in hostile environments is sure to continue to provide benefit to the wider diagnostic community, as well as driving diagnostic platform design to more flexible concepts, where the detection chemistry can be easily changed for different targets.

In Vitro Diagnostics and Weapons of Mass Destruction

This expert insight was written by Dr. Andrew S. Thompson, GlobalData's Senior Research Analyst covering Medical Diagnostics. For more information, or to enquire about an interview, please contact our press team on the details below.

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