Company: Claremont BioSolutions
Liaison(s): Bruce Irvine
Claremont BioSolutions (CBS) was established in 2006 as a spin-off from Keck Graduate Institute of Applied Sciences (KGI). CBS has developed a technology to purify DNA by mechanical lysis of micro-organisms prevalent in hospital acquired infections (HAIs). One of their products is the PureLyse™ device which is designed to purify PCR grade DNA within a short span of 3 to 5 minutes. In 2009, the Centers for Disease Control (CDC) estimated the direct medical costs from HAIs to be between $28-45 billion in the US alone, with the leading causative agent being Clostridium difficile, soaring hospital costs to nearly $4 billion annually. CBS is focused on providing a rapid, point-of-care (POC) integrated device that can be used in hospitals for rapid, accurate and immediate screening of Clostridium difficile. The CBS TMP has two major focuses: First, to conduct wetlab experiments to show feasibility of PureLyse™ in terms of providing adequate results upon purification of clinical samples and second, to develop a commercialization plan for the PureLyse™-integrated cartridge. The combined research will assist CBS in compiling proposals for future SBIR phase II applications. Due to safety containment issues, the CBS TMP could not work directly with Clostridium difficile, instead, the team used Bacillus subtilis as a target. Eventually, we mimicked a synthetic stool mix comprised of the most prevalent PCR inhibitory components and tested to demonstrate purification of target DNA by PureLyse™. Experiments were conducted to demonstrate detection limits for identification of lower range limits of severe infections. Additionally, medical swab experiments were done as per standard techniques used in hospitals currently and these results were also compared and contrasted with those of a leading market competitor. In total, we ran approximately 35 experiments to procure the data. For the PureLyse™-integrated cartridge commercialization plan, the TMP focused on the market assessment, and production and marketing plan. We determined the market size, competitive landscape, customer characteristics through a market research survey and interviews, and regulatory pathway and barriers to entry. We also provided recommendations for product distribution that would support future revenue goals.