PositiveID Corporation ("PositiveID"), an emerging growth company and developer of advanced technologies for diabetes management as well as sophisticated airborne bio-threat detection systems for America's homeland defense industry, announced today that it was awarded U.S. Patent No. 8,133,451 for its Dragonfly™ Rapid MDx Cartridge-based diagnostic system, which provides the ability to deliver molecular diagnostic results from a sample in less than 30 minutes. Dragonfly enables accurate diagnostics leading to the potential treatment scenarios at the point of care that are not possible with existing systems.
Dragonfly has been proven effective for a broad range of biological detection including radiation-induced cell damage within the human body, strains of influenza and other common pathogens and diseases such as E. coli, methicillin-resistant staphylococcus aureus (MRSA) and human papilloma virus (HPV). Dragonfly offers the precision of molecular diagnostics in an easy-to-use cartridge format that minimizes the possibility of human error. Typical current molecular diagnostic testing can take hours or even days, requires highly trained personnel and includes multiple handling steps.
William J. Caragol, Chairman and CEO of PositiveID, stated, "With Dragonfly, we have the ability to revolutionize the way healthcare is administered by enabling accurate diagnosis within minutes at the point of care, and before the patient leaves the physician's office. This allows healthcare professionals to prescribe the appropriate treatments immediately, helping to minimize the overuse of antibiotics, and enables rapid treatment and potential monitoring and quarantine measures for serious outbreaks such as certain forms of influenza."
The target markets for Dragonfly range from physicians' offices to urgent care and emergency departments that desire rapid test results and accurate diagnosis while the patient is present, and extend to military field deployments, border locations and others.
PositiveID Corporation is an emerging growth company and developer of advanced technologies for diabetes management and rapid medical testing, as well as airborne bio-threat detection systems for America's homeland defense industry. Its wholly-owned subsidiary, Microfluidic Systems, or MFS, is focused on the development of microfluidic systems for the automated preparation of and performance of biological assays in order to detect biological threats at high-value locations, as well as analyze samples in a medical environment.
Cepheid Receives Grant to Develop Sample Processing and Amplification Methods for Detection of Bloodstream Bacteria
Tuesday March 20, 2012
Cepheid today announced that, together with the University of Medicine and Dentistry of New Jersey (UMDNJ), it has received a grant from the National Institutes of Health to develop sample processing and amplification methods for highly-sensitive detection of bloodstream bacteria using nested polymerase chain reaction (PCR) on the GeneXpert® System. The $1.3 million grant is for the first year of an expected five-year, $5.5 million program.
While the program is being administered by the National Institute of Allergy and Infectious Diseases (NIAID) through its Partnerships for Biodefense special emphasis program, the company also expects to be able to employ the technology in future clinical products, including planned Xpert® tests for sepsis, ventilator pneumonia, and other critical infectious diseases.
"Cepheid's scientists will focus primarily on sample preparation methods for infectious agents from a wide variety of difficult sample types, especially whole blood — one of the most difficult specimens for sepsis detection," said John Bishop, Cepheid's Chief Executive Officer. "Clinicians want accurate, rapid results directly from a patient specimen without waiting for culture results. This program is expected to contribute to the advancement of products where difficult sample types are present."
Because even an extremely low concentration of bacteria present in a patient's blood can cause life-threatening sepsis, tests to detect blood stream infections (BSI) must be highly sensitive. Most blood stream infections are currently diagnosed by performing a series of blood cultures, a time-consuming process that typically takes days to produce a positive result, and even longer to predict treatment susceptibility.
The overarching goal of the project, scheduled to run through February 2017, is to develop tests to detect a variety of bacterial bioterrorism agents in the case of a terrorist attack. Principal investigator on the grant is Dr. David Alland of UMDNJ, and the work on select agents will be conducted in his laboratories.
"This is very similar to a previous NIAID-funded program conducted on tuberculosis, which supported development of six-color fluorescent detection and reagents-on-board," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "We considered that program to be a win-win because some of our tests, in addition to the MTB/RIF test, now employ six-color detection technology. We expect to see similar benefits — both direct and indirect — as a function of this new program, and expect to be able to fully leverage our capabilities in the areas of nested amplification and multiplex PCR pursuant to the next generation of GeneXpert products."
About the GeneXpert® System Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.