SANTA CLARA, Calif.—Affymetrix Inc. and PathGEN Dx Pte. Ltd.,a spinoff molecular diagnostics company founded by researchers from the GenomeInstitute of Singapore, recently announced they have signed an agreement todevelop a diagnostic test for pathogen detection.
Under the agreement, PathGEN Dx will develop an in-vitro diagnostic kit for comprehensive pathogen detectionusing their PathGEN PathChip that is based on a patented microarray-basedprotocol and analysis method. The kit will be comprised of PathGEN Dx'sproprietary reagents, an automated software package, and acontract-manufactured GeneChip microarray from Affymetrix. It will detect thepresence of more than 70,000 viral and bacterial genomes from a wide variety ofhuman samples, annotate the genomic information and identify co-infectingpathogens.
The inventors of the technology, originally from the GenomeInstitute of Singapore, A*STAR, approached Affymetrix in December 2010 with theaim to license the technology to Affymetrix. In April 2011, it was decided thata 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, Technologyand Research) is the lead agency for fostering world-class scientific researchand talent for a vibrant knowledge-based and innovation-driven Singapore.A*STAR oversees 14 biomedical sciences and physical sciences and engineeringresearch institutes, and six consortia and centers in the Singapore area.
"We are pleased to join the ranks of other PbA Programpartners, such as Roche Diagnostics and Pathwork Diagnostics, in adopting theAffymetrix 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 knownviral and bacterial genomes that infect humans," states Roger Schaller, seniordirector of global business development for clinical applications atAffymetrix. "It enables researchers to find the closest, previously sequencedmatch pathogen in their patient sample. For viruses or bacteria that have notbeen sequenced before, this chip would allow the discovery of novel geneticvariants, as well as new zoonotic recombinants, and co-infections. Thus, it isvery useful for epidemiology research, clinical biosurveillance research (forexample, surveys to determine what are the most common types of infections inpatients visiting the emergency room in a year), effects of co-infections ondisease severity and other research topics."
"We are very pleased to have PathGEN Dx join theAffymetrix's PbA Program. This adds significantly to our PbA Program in whichwe help partners to develop novel molecular diagnostic tests that willpotentially provide solutions for directing proper treatment for patients,"adds Schaller. "Since ddn noted theaddition of Signature Diagnostics to our program in 2010, we have added two newpartners and have several that we are working with as partners who will mostlikely become PbA partners in the coming 12 to 18 months. The partners havemade considerable progress in building out a large number of novel tests andbringing their cancer and genetic tests on line as CLIA-based offerings. Someare in the middle of clinical trials for FDA submission, including one academicpartner doing a three-site clinical trial on their breast cancer signature tobe a prognostic test and to drive drug therapy. There are several partners withtests that have been CE marked or in the process of obtaining a CE mark."
"We are very proud that PathGEN Dx, the first spinoff fromGIS, has achieved this collaboration that will significantly advance theirreach to the clinical diagnostics global market. The journey first began in2004 as a project in GIS, and then funded by Exploit Technologies in 2008 toclinically validate, productize and develop the business strategy. This is anexciting next phase in PathGEN DX's entrepreneurial journey and we look forwardto greater success," says Philip Lim, CEO of Exploit Technologies, A*STAR'stechnology transfer arm.
