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PathGEN inks pact with Affymetrix
SANTA CLARA, Calif.—Affymetrix Inc. and PathGEN Dx Pte. Ltd., a spinoff molecular diagnostics company founded by researchers from the Genome Institute of Singapore, recently announced they have signed an agreement to develop a diagnostic test for pathogen detection.
Under the agreement, PathGEN Dx will develop an in-vitro diagnostic kit for comprehensive pathogen detection using their PathGEN PathChip that is based on a patented microarray-based protocol and analysis method. The kit will be comprised of PathGEN Dx's proprietary reagents, an automated software package, and a contract-manufactured GeneChip microarray from Affymetrix. It will detect the presence of more than 70,000 viral and bacterial genomes from a wide variety of human samples, annotate the genomic information and identify co-infecting pathogens.
The inventors of the technology, originally from the Genome Institute of Singapore, A*STAR, approached Affymetrix in December 2010 with the aim to license the technology to Affymetrix. In April 2011, it was decided that a better avenue would be for the inventors to spin off a company, PathGEN Dx. In 2012, PathGEN Dx became a partner in the Partnered by Affymetrix Program (PbA).
A*STAR (formally known as the Agency for Science, Technology and Research) is the lead agency for fostering world-class scientific research and talent for a vibrant knowledge-based and innovation-driven Singapore. A*STAR oversees 14 biomedical sciences and physical sciences and engineering research institutes, and six consortia and centers in the Singapore area.
"We are pleased to join the ranks of other PbA Program partners, such as Roche Diagnostics and Pathwork Diagnostics, in adopting the Affymetrix technology in our IVD product development program," says Dr. Christopher Wong, founder of PathGEN Dx.
"This version of the research-use-only chip covers all known viral and bacterial genomes that infect humans," states Roger Schaller, senior director of global business development for clinical applications at Affymetrix. "It enables researchers to find the closest, previously sequenced match pathogen in their patient sample. For viruses or bacteria that have not been sequenced before, this chip would allow the discovery of novel genetic variants, as well as new zoonotic recombinants, and co-infections. Thus, it is very useful for epidemiology research, clinical biosurveillance research (for example, surveys to determine what are the most common types of infections in patients visiting the emergency room in a year), effects of co-infections on disease severity and other research topics."
"We are very pleased to have PathGEN Dx join the Affymetrix's PbA Program. This adds significantly to our PbA Program in which we help partners to develop novel molecular diagnostic tests that will potentially provide solutions for directing proper treatment for patients," adds Schaller. "Since ddn noted the addition of Signature Diagnostics to our program in 2010, we have added two new partners and have several that we are working with as partners who will most likely become PbA partners in the coming 12 to 18 months. The partners have made considerable progress in building out a large number of novel tests and bringing their cancer and genetic tests on line as CLIA-based offerings. Some are in the middle of clinical trials for FDA submission, including one academic partner doing a three-site clinical trial on their breast cancer signature to be a prognostic test and to drive drug therapy. There are several partners with tests that have been CE marked or in the process of obtaining a CE mark."
"We are very proud that PathGEN Dx, the first spinoff from GIS, has achieved this collaboration that will significantly advance their reach to the clinical diagnostics global market. The journey first began in 2004 as a project in GIS, and then funded by Exploit Technologies in 2008 to clinically validate, productize and develop the business strategy. This is an exciting next phase in PathGEN DX's entrepreneurial journey and we look forward to greater success," says Philip Lim, CEO of Exploit Technologies, A*STAR's technology transfer arm.