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With Aviir in Bankruptcy, Former Employees Launch New Firm Offering Protein Test for Cardiac Risk

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NEW YORK (GenomeWeb) – With cardiac test developer Aviir having entered bankruptcy at the beginning of the year, former employees of the company last month launched a new firm, Global Discovery Biosciences, through which they plan to offer a proteomic test for the assessment of cardiovascular risk.

Leading the effort is Douglas Harrington, formerly CEO of Aviir and now managing partner at HealthMed Holdings, a holding company that owns GDB. HealthMed announced in February that it had completed validation of its cardiac risk test, named the Myocardial Assessment Profile, or MAP test, and was "actively commercializing" it.

GDB is planning to launch the test within the next two months, Harrington told ProteoMonitor. The company is "particularly interested in Asia including India and China, as well as the Middle East and Europe," as markets for the test, he said. He added that the company is also developing a point-of-care device to run it on.

The MAP test is intended to identify patients with unstable cardiac lesions by measuring the levels of plasma proteins in pathways linked to those lesions due to inflammation.

The test, Harrington said, is intended primarily to identify patients within an intermediate-risk population who are at elevated risk of suffering a heart attack due to the rupture of unstable lesions within the next five years.

"What we're looking at are the patients who really need to be addressed, those that have lesions that are prone to rupture," he said. "Lots of people have [arterial] plaques, but not all are going to rupture. And the [protein] biomarkers give you a clue as to which ones are most likely to rupture."

In this, the test is similar to the MIRISK VP test developed by Aviir, which likewise measured proteins related to unstable arterial plaques due to inflammation. MIRISK was also intended to better predict intermediate-risk individuals' risk of suffering a heart attack within a five-year window.

Harrington said that he had developed the test over the last six months. The validation work, which comprised analysis of between 4,000 and 5,000 archived samples, began in December, he said.

Harrington stepped down as CEO of the company in September of last year as part of a partnership deal between Aviir and Qatar Heart Lab Holdings, the investing arm of TriValley Group, a conglomerate owned by Khalid Bin Jabor Mohamed Al Thani, a member of Qatar's ruling family. As part of that agreement, Harrington joined Qatar Heart Lab Holdings as managing director. TriValley Group also owns HealthMed Holdings.

In addition to offering the MAP test, GDB also plans to offer test development and validation services through its CLIA lab, Harrington said.

"We've noticed that a lot of companies have been forming their own labs for LDTs and such things, which is very expensive and not very efficient," he said. "So we have a co-tenancy concept where we have the CLIA lab and we have the team that knows how to scale up [a test] and complete the validation studies and take it through regulatory approval if need be."

The company currently has "several projects from other groups that are following [this model]," he said, adding that while GDB hasn't yet opened its CLIA lab, it plans to in the near future.

Aviir, meanwhile, is in the midst of bankruptcy proceedings. The company filed for Chapter 7 bankruptcy on Jan. 27 in US Bankruptcy Court in the Central District of California Santa Ana Division. According to the filing, the firm has between $1 million and $10 million in assets and owes between 200 and 999 creditors somewhere between $10 million and $50 million.

Representatives of the company did not respond to requests for comment, but Harrington said that he believed the bankruptcy resulted not from the performance of the company but, rather, a dispute between its various investors.

"The company was doing very well," he said. "They were experiencing logarithmic growth. I think there was an attempt to restructure some loans and maybe some disagreement among the investors."

Aviir's bankruptcy filing would seem to support Harrington's assertion. According to the filing, the company notched $3,426 in sales in 2011, $632,743 in 2012, and $1.4 million in 2013.

It began a broad commercial launch of the MIRISK VP test in March of last year. At that time it had contracts for the test with five preferred provider organizations, covering roughly 80 million lives.

Additionally, in June, Aviir secured the final $10 million tranche of a $30 million financing round it began in December 2011. Completion of that final tranche was contingent on hitting certain commercial metrics, suggesting that, at least as of the middle of last year, the company remained on track.

The company's main investors were Merck Global Health Innovation Fund, Bay City Capital, Aberdare Ventures, New Leaf Venture Partners, and Partners & Partners. Al Thani is also director of P&P, which is an investor in GDB, as well.

Launched in 2005, Aviir was formed to commercialize cardiac biomarker research done at Stanford University. The MIRISK VP measured levels of seven proteins linked to the development of vulnerable arterial plaque.

In addition to its proteomic work, Aviir also had programs in genomics and planned to launch next-generation sequencing-based assays for investigating congenital cardiac pathologies like long QT syndrome. It was also working on genomic tests to predict the effectiveness of particular statins for a given patient.

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