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Founded 2003 in Cambridge, MA

Pharma, biotech & VC clients in life sciences

Strong ties with the life science VC & biotech in US and EU

Corporate & product strategy, valuation analysis, product positioning and messaging

informed by clinical, scientific and VC expertise

Is it hype? Obstacles in VC for Dx

• What is the FDA’s role in regulation of MDx?

• How will MDx be priced?

• How does this get reimbursed?

“Breakeven [for Genomic Health] is predicated on a $3,000 price point,” Kreidel observed, “not something most diagnostics companies can aspire to”--except, we would argue, in oncology.

“We don’t doubt that it will be solved because there is the compelling need in the marketplace for many of these tests…We’re just concerned about the timeline while this is resolved.”

“We find that entrepreneurs, in general, have not done enough homework to specifically define the cost savings that their tests will provide,” Gullans said. “If a test is going to be priced at several thousand dollars over the course of a disease, you need to know the healthcare system is going to save that, and specifically which part of the healthcare system will save that.”

Dealstyles of the rich & famous: not much Dx

Some well-known life sciences funds (2010)

Ahead of the curve? VCs with a Dx focus

Some of the savvy Dx funds (2010)

Recent deals in Dx (just since summer 2010)

Examples of innovative Dx startups

Characterizes and targets the bacteria found in the human gut to give better diagnostics

Characterizes exosomes isolated from blood as a new approach to identify predictive cancer biomarkers

Uses iterative in situ click chemistry to create antibody-like protein capture agents

Goal: Characterize how patients will respond to certain therapies, and explore new therapies that factor in bacterial response.

Goal: Better biomarker screening assays that are more comprehensive, accurate, and faster to develop.

Goal: Improved sensitivity and detection of early stage diseases that are a challenge to diagnose.

Develops a device to examine gastrointestinal tissue for precancerous and cancerous cells.Goal: Give gastroenterologists a real-time diagnostic tool that would allow patients to get immediate treatment following an examination.

Uses quantitative multi-parameter assays that define risk of metastasis and recurrence by measuring the functional genetic elements that drive tumor aggressiveness.Goal: Fundamentally change the way in which cancer is diagnosed and save costs for the healthcare system.

Dx – the next feeding frenzy in VC?