MicroPhage milestones
It's amazing how quickly time has passed at MicroPhage. Here is a brief history of our company.
2002 – The beginning
MicroPhage is incorporated by Jack Wheeler and Kent Voorhees with the purpose of commercializing a bacterial detection technology exclusively licensed from the Colorado School of Mines in Golden, Colorado.
2003 – Early success
MicroPhage quickly demonstrates the reliability and ease-of-use of detecting bacteriophage amplification with alternative methods, including lateral flow immunochromatography (LFI), enzyme linked immunosorbant assay (ELISA), optical immunoassays (OIA), and real-time polymerase chain reaction (RT-PCR).
2004 – A new office
After raising its first capital from a group of angel investors, MicroPhage moves into a new 5,000-sq. ft. facility in Longmont, Colorado.
2005 – Refocusing efforts
MicroPhage narrows its focus to clinical application, where fast, easy-to-use bacterial detection would significantly and positively affect patient care.
2006 – Targeting S. aureus
MicroPhage further narrows the development focus from three clinical targets to one – S. aureus – and determines the test of highest clinical value would directly identify this organism in blood cultures. To meet the goal of product introduction, MicroPhage establishes a quality assurance and clinical trial group.
2007 – Expanding portfolio
MicroPhage successfully demonstrates high performance in determining antibiotic susceptibility and resistance for S. aureus in blood culture and nasal swab models.
2008 – Clinical trials
A series of clinical studies on MicroPhage's two leading products for S. aureus and MSSA/MRSA identification take place in a number of premier clinical sites throughout the U.S. Full FDA-required clinical trials are slated to begin late in the year, pending design input from the FDA and Centers for Medicare and Medicaid.
Progress to date is more typical of a whole year's work. The company now has raised more than $10 million solely from angel investors as we move toward clinical product. Laboratory management grew this year as well with the addition of Dipankar Manna, Ph.D. as Senior Scientist.
The company began its first set of clinical studies on prototype devices at a number of clinical sites throughout the country in July. Eager to demonstrate the performance in the "real world" that we have seen in our laboratory, these trials are the first of a series of three trial efforts that will be used to support FDA clearance of our products in the next year.
And beyond...
Although the future is not history, it is always good to know where a company is headed. Slated for 2008 are a series of larger clinical studies of the company's two leading products for S. aureus / MSSA / MRSA identification at a number of premier clinical sites throughout the U.S. Full FDA-required clinical trials are slated to begin late in the year, pending FDA and CMS (Centers for Medicare and Medicaid) design input. The company will begin additional indications for its current test, as well as develop its bacterial and antibiotic testing pipelines with additional research efforts launching in Q2 2008. The company expects to have product cleared by the US FDA in 2009 and CE Marking the same year to support local and international sales.