PROOF for FFPE samples

HTG will develop the assay on itsproprietary qNPA platform. Vancouver-based PROOF Centre—anot-for-profit organization focused on developing blood tests forchronic organ disease—will be involved in the clinical validationin Canada and provide key opinion leader support for regulatoryapproval in North America.

Lung attacks are the leading cause ofemergency room visits and hospitalizations among chronic COPDsufferers, accounting for more than $5.7 billion direct and $6.7billion indirect healthcare costs every year in Canada alone.According to the World Health Organization (WHO), an estimated 210million people worldwide have COPD, and 3 million deaths areattributed to the disease annually. WHO predicts COPD will become thethird-leading cause of death by 2030. A large portion of COPD-relatedmortality is due to lung attacks. Like lung cancer, COPD is seen mostfrequently among tobacco smokers.

"We started working with PROOFseveral years ago on an organ rejection assay as they were lookingfor a multiplexed gene expression solution," says TJ Johnson, CEOof HTG. "This agreement is the first of many that HTG and PROOFCentre hope will bring medically valuable biomarker tests to theclinic. Basically, our platform is an extraction-free chemistry formultiplexed analysis of RNA. We are preparing to launch a newplatform we call EDGE that provides walkaway automation and less than24-hour turnaround. First steps are to fully develop the COPD assay,integrate it onto our EDGE automation system, install the system andbring the assay up in the PROOF CLIA lab, complete the validation andthen prepare for full commercialization."

HTG's core technology is itsquantitative nuclease-protection assay, or qNPA platform, whichenables researchers to observe gene-expression levels in hundreds orthousands of samples simultaneously without requiring RNA extraction,cDNA synthesis, RNA amplification or RNA-labeling steps. These stepsare often performed on other gene-expression platforms, Johnsonnotes.

HTG currently sells qNPA ArrayPlatesthat can analyze gene-expression levels in as many as 47 multiplexedgenes in a 96-well format. The company has also made its assayplatform-agnostic by striking deals with other tool manufacturers.For instance, it penned an alliance with Luminex last year and onewith Roche NimbleGen in 2009.

While HTG has traditionally sold itsproducts to researchers, in recent years, it has set its sights onthe clinical molecular diagnostics market. As a result of this shiftin emphasis, the company changed its name from High ThroughputGenomics to HTG Molecular Diagnostics in March 2012.

According to Johnson, scientists canuse the qNPA assay to profile gene expression in formalin-fixedparaffin embedded samples as part of an extraction-free protocol—anability that he is convinced gives HTG an edge in the diagnosticsspace.

"Although we effectively handle mostsample types, we offer the greatest advantages with FFPE," he says."Our extraction-free protocol is effective assessing the solubleand nonsoluble RNA in FFPE."

He also cites a "significant marketneed" to work with smaller sample sizes, and says HTG's assays"work effectively with less than a single 5-micron section oftissue."

"The development of these blood testshas been driven by a huge unmet clinical and social need," says Dr.Bruce McManus, director of the PROOF Centre. "This agreement withHTG Molecular Diagnostics will facilitate bringing these tests tomarket faster, providing physicians with tools to improve patientcare and management and help alleviate suffering of patients withCOPD."