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PROOF for FFPE samples
TUCSON, Ariz.—HTG Molecular Diagnostics and the Centre of Excellence for the Prevention of Organ Failure (PROOF Centre) have finalized a license agreement that provides HTG exclusive rights to commercialize PROOF Centre-developed gene expression blood tests to evaluate the prognosis of chronic obstructive pulmonary disease (COPD) patients who are likely to experience frequent exacerbations known as lung attacks.
HTG will develop the assay on its proprietary qNPA platform. Vancouver-based PROOF Centre—a not-for-profit organization focused on developing blood tests for chronic organ disease—will be involved in the clinical validation in Canada and provide key opinion leader support for regulatory approval in North America.
Lung attacks are the leading cause of emergency room visits and hospitalizations among chronic COPD sufferers, accounting for more than $5.7 billion direct and $6.7 billion indirect healthcare costs every year in Canada alone. According to the World Health Organization (WHO), an estimated 210 million people worldwide have COPD, and 3 million deaths are attributed to the disease annually. WHO predicts COPD will become the third-leading cause of death by 2030. A large portion of COPD-related mortality is due to lung attacks. Like lung cancer, COPD is seen most frequently among tobacco smokers.
"We started working with PROOF several years ago on an organ rejection assay as they were looking for a multiplexed gene expression solution," says TJ Johnson, CEO of HTG. "This agreement is the first of many that HTG and PROOF Centre hope will bring medically valuable biomarker tests to the clinic. Basically, our platform is an extraction-free chemistry for multiplexed analysis of RNA. We are preparing to launch a new platform we call EDGE that provides walkaway automation and less than 24-hour turnaround. First steps are to fully develop the COPD assay, integrate it onto our EDGE automation system, install the system and bring the assay up in the PROOF CLIA lab, complete the validation and then prepare for full commercialization."
HTG's core technology is its quantitative nuclease-protection assay, or qNPA platform, which enables researchers to observe gene-expression levels in hundreds or thousands of samples simultaneously without requiring RNA extraction, cDNA synthesis, RNA amplification or RNA-labeling steps. These steps are often performed on other gene-expression platforms, Johnson notes.
HTG currently sells qNPA ArrayPlates that can analyze gene-expression levels in as many as 47 multiplexed genes in a 96-well format. The company has also made its assay platform-agnostic by striking deals with other tool manufacturers. For instance, it penned an alliance with Luminex last year and one with Roche NimbleGen in 2009.
While HTG has traditionally sold its products to researchers, in recent years, it has set its sights on the clinical molecular diagnostics market. As a result of this shift in emphasis, the company changed its name from High Throughput Genomics to HTG Molecular Diagnostics in March 2012.
According to Johnson, scientists can use the qNPA assay to profile gene expression in formalin-fixed paraffin embedded samples as part of an extraction-free protocol—an ability that he is convinced gives HTG an edge in the diagnostics space.
"Although we effectively handle most sample types, we offer the greatest advantages with FFPE," he says. "Our extraction-free protocol is effective assessing the soluble and nonsoluble RNA in FFPE."
He also cites a "significant market need" to work with smaller sample sizes, and says HTG's assays "work effectively with less than a single 5-micron section of tissue."
"The development of these blood tests has been driven by a huge unmet clinical and social need," says Dr. Bruce McManus, director of the PROOF Centre. "This agreement with HTG Molecular Diagnostics will facilitate bringing these tests to market faster, providing physicians with tools to improve patient care and management and help alleviate suffering of patients with COPD."