Mines technology gains FDA clearance
GOLDEN, Colo., May 6, 2011 – A lifesaving technology originally developed at Colorado School of Mines gained U.S. Food and Drug Administration (FDA) clearance today, allowing it to be marketed to health care providers.
The FDA granted clearance to MicroPhage, Inc.’s KeyPathTM MRSA/MSSA Blood Culture Test, which can deliver critical results within hours on patients infected with deadly antibiotic-resistant Staphylococcus aureus bacteria. In just five hours, using two small reaction tubes and a cassette containing two small test strips, the assay identifies whether blood culture specimens are infected with staph and determines if the culture has methicillin antibiotic resistance (MRSA) or susceptibility (MSSA). Without this technology the process can take up to three days and at times lead to patient mortality.
Currently, as many as half of all patients diagnosed with Staph aureus are initially prescribed the wrong antibiotics, contributing significantly to the thousands of deaths caused each year in the U.S. by antibiotic-resistant bacteria. Alone, methicillin-resistant strains of Staph aureus, known as MRSA, kill more than 19,000 Americans each year.
“MRSA and other antibiotic-resistant ‘superbugs’ represent one of the great public health challenges of our century, and identifying those dangerous bacteria early is crucial in both treating patients and limiting the spread of the infection to others,” said Don Mooney, president and chief executive officer at MicroPhage. “This test is a timely and a much-needed improvement to an important area of hospital and laboratory medicine.”
Dr. Kent Voorhees, a professor in the Department of Chemistry and Geochemistry at Colorado School of Mines, and former PhD student Angelo Madonna, developed the technology for the MRSA/MSSA Blood Culture Test — now trademarked by MicroPhage as the Bacteriophage Amplification Technology (BAT™). This technology exposes bacteria to antibiotics, delivering true phenotypic antibiotic susceptibility results.
“It is very satisfying to know that your scientific contribution will benefit society,” said Voorhees. “The citizens of Colorado will both benefit from the healthcare improvement it provides and profit from this technology through job creation and innovative notoriety. The staff at MicroPhage should be congratulated because a very small percentage of start up companies receive this honor.”
In 2002, Voorhees and Jack Wheeler incorporated MicroPhage with the purpose of commercializing the technology, which was exclusively licensed from Colorado School of Mines.
“The success of Microphage shows what happens when innovative technology is transferred out of a university to the right company,” said Mines Vice President of Research and Technology Transfer Dr. John Poate. “The Colorado School of Mines continues to make research breakthroughs in not only our core strengths of energy and the environment, but in fields such as biotechnology, advanced computing and engineering. We will continue to bring these breakthroughs to market through the appropriate pathway to provide for the economic development of the state and the nation.”
Since inception, MicroPhage, Inc. has attracted millions of dollars in investments, gained clearance to sell commercial medical diagnostic products in Europe, received a 2009 R&D 100 Award and now occupies a 5,000-square foot office in Longmont, Colo.