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Lee Hood’s Firm to Use Proteomics, Other Technologies to Develop Diagnostic Tools

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By Tony Fong

Lee Hood’s newly launched company, Integrated Diagnostics, will try to leverage previously discovered biomarkers and translate them into tests for a broad range of diseases.

The company, whose debut this week was funded with $30 million in a Series A financing round, said it intends to put its first test on the market within four years.

While proteomics will play a major role in Integrated Diagnostics’ plans, Paul Kearny, a co-founder, president, and chief scientific officer, said the Seattle-based shop is not strictly a proteomic diagnostics firm because technologies other than mass spectrometers will be used.

Indeed, in its statement announcing its launch, the company said that it will develop products based on breakthroughs using both genomic and proteomic technologies to identify organ-specific proteins.

"We'll be licensing a lot of the discovery data” from Hood’s other endeavor, the Institute for Systems Biology, and other undisclosed places, "so we won't be doing a lot of the discovery work ourselves," Kearny told ProteoMonitor. "We'll be using organ-specific proteins as well as disease-modulated proteins in our discovery sets."

Integrated Diagnostics plans to verify those biomarkers by multiple-reaction monitoring, and then develop assays in a high-throughput manner. Kearny said the assays will be "much larger than assays that have been reported in the literature or [are] available commercially."

While the approach of many protein-based diagnostics development has been to run studies on a small handful of biomarkers, Integrated Diagnostics is taking a contrapuntal strategy.

The traditional approach raises the risk of failure because no one can know which proteins will complement each other on a panel, so "it's much more reliable to do a verification of 500 proteins and find out then which 10 or 15 work well together to form a diagnostic panel," Kearny said.

”What we've tried to do at Integrated Diagnostics is say: ‘What are the best technologies out there right now for bringing a proteomics-based diagnostic to market, and what are the components that you need?’" Kearny said.

"And you certainly need the ability to monitor a large number of proteins because in personalized medicine and complex diseases, if you take an individual who's on a drug and has a complex disease, and you're trying to determine if the drug is the right drug for that person, and monitoring the progression of the disease, it's unrealistic to think that a handful of proteins is going to be sufficient to understand that situation," he added.

The company, whose tests will be blood-based, is targeting the lab-based diagnostics market. It has not yet decided what diseases specifically to target but is generally interested in those with clinically unmet needs.

While genomic approaches lend themselves well to some ailments, such as breast and prostate cancer, because getting tissue samples is relatively straightforward, tissue sampling for other cancers, as well as central nervous system diseases such as Alzheimer's disease, is not as simple.

"We're looking at the market in a sophisticated way in terms of both the business side [and] the technical feasibility: Which indications lend themselves to our technology?" Kearny said.

The initial assay development and verification work will be mass spec-based. Integrated Diagnostics also has licensed a protein-affinity reagent technology that uses synthetic peptides as a replacement for antibodies. The technology was developed by James Heath, a co-founder of the company and a professor of chemistry at the California Institute of Technology.

According to Kearny, the technology is "extremely highly stable over antibodies, which can be quite fickle to handle." He added that it can reduce the development time and manufacturing costs of high-affinity protein capture agents by 25- to 50-fold over traditional antibody development approaches.

In addition, the company licensed a microfluidic technology, also developed by Heath, that uses a barcode chip to measure a panel of proteins over a wide dynamic range [See PM 12/05/08].

That technology is not a main focus of Integrated Diagnostics, though, "and we see those coming on in later years when they're needed," Kearny said.

$30M to Play With

The launch of Integrated Diagnostics comes at a time when clinical proteomics is still trying to prove its credibility and protein-based diagnostic businesses are fighting for survival.

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Just this week, Australian firm Tyrian Diagnostics and Becton Dickinson severed a collaboration designed to develop a test for active tuberculosis because neither company could consistently detect Tyrian's lead biomarker in clinical samples [See accompanying story this issue].

The "distinguishing factor" that improves Integrated Diagnostics' chances for success, Kearny said, is that it is "stocked with emerging proteomic technologies," though he declined to describe many of them because they are proprietary. The company is also well-networked with leaders in clinical proteomics, he added.

One barrier to clinical proteomics, he said, has been a gap between the research being conducted by academic scientists and the needs of the clinical proteomics market.

"They're addressing clinical problems that actually are not clinical problems in practice," he said. "At Integrated Diagnostics we've assembled a team … who are very aware of what the clinical unmet needs are and at pointing the best approaches in clinical proteomics at those problems."

The $30 million, which Integrated Diagnostics will use for product development, doesn't hurt, either.

"We're also extremely well financed, which allows us to think and act in a bigger way than other companies in the past," he said.

The lead investor on the Series A round is InterWest Partners, a Silicon Valley-headquartered venture capital firm. It was joined by the Wellcome Trust and Dievini Hopp Biotech holding. Dievini's participation is part of a collaboration with the Grand Duchy of Luxembourg, which may become part of the investor group eventually, the company said.

Luxembourg, whose economy has historically depended on the financial sector, recently embarked on an initiative to jumpstart its still-developing biotech industry. The initiative includes a public-private partnership with Hood’s ISB, and Integrated Diagnostics is, in part, a product of that partnership.

While Hood's name may have opened doors to potential investors, in the end it was the technology and the proposed application of it that was the key factor in securing the funding, especially in the tight-fisted capital market of the past year, Kearny said.

Getting InterWest on board early was also key. During the past year, it has advised Integrated Diagnostics on its business plan and "helped us place our technologies in the business plan appropriately," and helped form the investor syndicate for the Series A round, he said.

In a statement, Arnold Oronsky, general partner at InterWest, said Integrated Diagnostics represents two important investing models: The first is a public-private partnership that seeks to advance healthcare, achieve a return on investment, and "spur on growth of a nation's healthcare industry."

The second is the growing importance of investing in science to allow a better understanding of complex biological systems associated with diseases.

"There is a huge market for diagnostic tools that can make sense of that complexity," Oronsky said. "We believe Integrated Diagnostics is well placed to meet that need."

The $30 million Series A will be followed with a Series B financing round in about four years when the company anticipates its first product to be ready for commercialization.

In addition to Kearny, Hood, and Heath, Integrated Diagnostic's fourth co-founder is David Galas, a professor at ISB and vice president and CSO at Battelle Memorial Institute.

Hood and Heath are on the company's board, and Galas is the firm's scientific advisor, but Kearny will be the only one of the four who will be involved in the company on a day-to-day basis.

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