A Medical Device Daily
Cepheid (Sunnyvale, California), a molecular diagnostics company, reported receiving Phase II funding from the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health for a Small Business Technology Transfer (STTR) Grant titled, “Sample Processing Cartridges for Rapid PCR TB Detection.” The amount of the funding was not disclosed.
Cepheid's academic partner for this program is Dr. David Alland, of the University of Medicine and Dentistry of New Jersey (UMDNJ). Cepheid and UMDNJ previously reported a program for development of a PCR cartridge that detects the presence of Mycobacterium tuberculosis and also predicts drug resistance, in about one hour.
The program is being supported by FIND (Geneva), a non-profit organization partnered with the Bill and Melinda Gates Foundation. The NIAID funding will complement these efforts by focusing on development of sample collection devices and proprietary nucleic acid dyes, quenchers, interpretive software and other technologies associated with commercial implementation of a six-color GeneXpert system.
The goal of both programs is to develop a rapid test with accuracy equal to or better than current methods, thus shifting the burden from culture techniques which require weeks to months to generate the same results.
“Our GeneXpert system enabled the recent attainment of the first ever moderate complexity categorization for a PCR-based assay. This gives us confidence that we can deliver, for use in developed and developing countries alike, rich-featured molecular diagnostics assays that provide medically actionable results in real time,” said David Persing, MD, PhD, Cepheid's chief medical and technology officer and principal investigator on the award.
In other grants/contracts:
• Pharsight (Mountain View, California), a provider of software and services for clinical drug development, said it has entered into the largest single project workplan in its history, for integrating the services of drug/disease modeling, meta-data analysis and model visualization.
It said that the multi-quarter agreement, of nearly $900,000 in value, exemplifies the benefit delivered by combining Pharsight's Strategic Consulting Services (SCS) expertise and software tools, such as Drug Model Explorer (DMX), to address portfolio prioritization.
SCS will apply Pharsight's methodologies for drug/disease modeling and simulation to the client's development compounds and to existing competitive compounds to understand the likelihood of client drug candidates outperforming competitive drugs. The results will be communicated to members of the development team using Pharsight's web browser-based software tool, DMX, an intuitive visualization tool that illustrates modeled drug attributes, such as exposure-response or dose vs. side effect, allowing any member of the drug development team to visually compare anticipated market performance of drug candidates.
“We are seeing a number of large contracts integrating multiple Pharsight software tools and methodologies and this new opportunity is the largest such engagement we have achieved to date,” said Shawn O'Connor, president/CEO, and chairman of Pharsight. “The FDA's call for more modeling and simulation in the Critical Path Initiative and the rising costs of drug development continue to drive adoption of our entire spectrum of tools and services.”
• Velcura Therapeutics (Ann Arbor, Michigan) reported receiving a $274,000 Phase I Small Business Innovation Research grant from theNational Institute on Aging (NIA) to further identify genes and/or protein networks modulated during human bone formation.
Velcura said it was the first corporation to grow human bone in tissue culture and has multiple patents on this process. The company uses its platform bone-growth technologies to discover and optimize drugs stimulating bone formation for use in treating diseases such as osteoporosis.
“This NIA grant allows us to significantly advance our understanding of how genes and their protein-products work together inside a cell to bring about bone formation,” said Velcura's president/CEO Michael Long, PhD. “Velcura's scientific team had identified about 1,200 genes involved in this process by 2004.”
“Yet, only knowing the names of these key genes without understanding their functional interactions, just makes us hit the wall faster,” he added. “To succeed in fighting osteoporosis and other diseases, we have to understand how these genes work together and which ones are crucial to the bone formation process.”
This is Velcura's third NIA SBIR award that funds the initial phases of this gene/networks study. The company plans to apply to the NIH for a Phase II SBIR that will help translate these mechanisms of action studies into a commercial endeavor.
Velcura Therapeutics uses adult stem cells to grow human bone in tissue culture and to develop therapies for osteoporosis and other bone diseases.