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HTG to Commercialize PROOF's COPD Risk Stratification Test; Aims for Launch Next Year

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Canada's Prevention of Organ Failure Centre of Excellence has granted HTG Molecular Diagnostics exclusive rights to commercialize a risk stratification test the center has been developing to better personalize treatment for chronic obstructive pulmonary disease.

The PROOF Centre received C$1.5 million (US$1.5 million) in funding from Genome British Columbia earlier this year to develop the test from a promising set of biomarkers (PGx 4/25/2012).

Under the agreement, HTG will develop the assay on its proprietary quantitative Nuclease Protection Assay technology. According to HTG's CEO TJ Johnson, qNPA is a multiplex, gene expression-based platform that uses a "non-extraction, non-PCR-based chemistry."

Researchers from the PROOF Centre will stay involved in the clinical validation of the test, and will also support HTG's application for regulatory approval in the US after an initial commercial launch through PROOF in the middle of next year, according to the company.

Johnson told PGx Reporter that HTG has been working with the PROOF Centre for several years in research programs for a handful of disease/diagnostic areas.

"We listened to the PROOF group as they looked at the COPD market and the potential it had to bring a test that would really help patients and bring a lot of benefit to the system. This was the first indication [among our collaborations] that reached a level of maturity to move forward on," he said.

According to Genome BC, COPD exacerbations are a leading cause of emergency hospital admissions among chronic disease sufferers across Canada and elsewhere. COPD attacks account for more than C$5.7 billion in direct healthcare costs and C$6.7 billion in indirect healthcare costs every year.

PROOF began work to discover the biomarkers that will be the backbone of the new test, hoping to improve outcomes and save money by giving physicians a way to identify which patients with a mild presentation of COPD are likely to progress to more serious disease in the future.

This could help doctors make personalized treatment decisions earlier in the disease course: either more aggressive doses of current therapies like physiotherapy, bronchodilators, and other corticosteroids for those with high risk of exacerbation, or potentially a reduction of therapy for those predicted to have more mild disease.

"It's really a prognostic to help understand, early on, if a patient is likely going to progress to more serious disease so interventions can take place earlier and at less cost," Johnson said.

Earlier this year, Genome BC said it expected the PROOF team to be able to start proof-of-concept studies in the clinic "within two to three years." With the newly announced agreement with HTG, this timeline has been accelerated.

Johnson said HTG and the PROOF Centre have a "very extensive co-development program and timeline already laid out."

He said the company's current intention is to have the test validated and "ready to go on the market by the second quarter of next year.

By the first quarter of next year, HTG also plans to begin selling its automated qNPA system.

"We are looking forward to putting one of our first new automated instruments to run this chemistry in the PROOF center for [the COPD test] application," Johnson said.

Johnson declined to provide details on the biomarkers that will make up the signature for the commercial assay, but said that the final set will be between 10 and 20 markers.

Bruce McManus, a co-leader for the PROOF COPD project, told PGx Reporter in April that the biomarkers the group was working with to develop and validate the test included molecules related to immune cell products, proteins associated with chronic lung injury and altered repair, as well as genes that reflect immune cell activation or relate to biological functions like cell migration and adherence.

Johnson declined to detail the company's plans to validate the test with the PROOF Centre in anticipation of its launch mid-next year. He did say the group is "comfortable that we are far enough along with the technology and feasibility part of it that we can [move to] clinical validation."

The initial launch of the test will be through the PROOF Centre, according to Johnson. After that, the center will work with HTG to support its application for approval of the test as an in vitro diagnostic by the US Food and Drug Administration.

As part of its funding from Genome BC, the PROOF Centre said last April that it would also be conducting outcome studies and cost-effectiveness research on the COPD test. Johnson said HTG plans to collaborate with the center on that work as well.

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