This story was originally published on April 13.
Chronix Biomedical said today that it is partnering with the University of Calgary to develop a commercial version of Chronix's serum DNA-based blood test for the early detection of bovine spongiform encephalopathy, also known as mad cow disease.
The BSE assay will be the first commercial application of Chronix's technology, which detects, amplifies, and sequences disease-specific circulating nucleic acids that are released into the bloodstream by damaged and dying cells.
Researchers from Chronix and the University of Calgary will develop the test using a C$1.5 million ($1.49 million) grant from the Alberta Livestock and Meat Agency and Genome Canada.
The grant will generally be split three ways, Chronix CEO Howard Urnovitz told PCR Insider today: Acquiring samples of BSE from around the world; sequencing studies, the bulk of which will be performed at Chronix; and bioinformatics, mostly at the University of Calgary.
Once the test has been developed and validated, Chronix said that it intends to begin offering BSE testing services to the cattle industry first in Canada, then eventually in other countries including the US.
"Canada is mostly an exporting beef country, and they will be testing it in Alberta first, and then working with various importing countries to show that they have the validation studies done, and have [the cattle] tested before they ship," Urnovitz said.
"And of course we'll look forward to working with the US, both with the cattle industry and US government, to make sure that option's available," Urnovitz added.
Currently, BSE can only be definitively diagnosed with a post-mortem brain biopsy. Chronix's technology, which detects, amplifies, and sequences nucleic acids from serum samples, has been shown to accurately detect BSE in cattle before disease symptoms are evident.
Specifically, in a paper published last February in Nucleic Acids Research, scientists from Chronix, the University of Calgary, the University of Gottingen, and other institutions demonstrated the use of Chronix's method to identify disease-specific motifs in circulating nucleic acids from live elk and cattle infected with BSE and a related disease.
"We're dealing with very minute amounts of nucleic acid in the serum, so there will probably always be an amplification step involved," Urnovitz said.
Chronix's test will detect damage occurring in the nerve cells of cows. "As the infectious agent does its damage over time, we can pick up the signature sequences of these specialized nerve cells," Urnovitz said.
Chronix will also work to identify critical sequences that define BSE in a cow, "and as we do that, we'll keep our eye open as to whether we'll do primer design so we can put this on a Luminex or Illumina platform; or, if the cost of direct sequencing comes down precipitously, as it has this year, we may just go right to direct sequencing, which would keep the cost down," Urnovitz added.
"The technology from Chronix is the first to demonstrate the potential to achieve our goal of an accurate, cost-effective assay that will revolutionize BSE testing, making it economically and logistically feasible to screen all cattle in the food chain before BSE symptoms appear," Christoph Sensen, a professor of medicine at the University of Calgary and principal investigator of the grant-supported research project, said in a statement.
Chronix is also developing serum DNA-based blood tests for human diseases, including cancer and chronic neurological conditions. It has published studies demonstrating the utility of its approach in detecting early-stage breast cancer and the presence or absence of active disease in multiple sclerosis patients.
The company said that it will also be disclosing more information about its work with the University of Alberta, as well as breast and prostate cancer study results, at the 2010 American Society of Clinical Oncology meeting in June.