Staff Writer

Foundation Medicine Inc. is expected to announce Thursday that it has raised $25 million in Series A financing from Third Rock Ventures to begin the arduous process of bringing cancer genome analyses to the masses.

"This is an ambitious and audacious company," admitted Alexis Borisy, founding CEO of Cambridge, Mass.-based Foundation and entrepreneur-in-residence for Third Rock.

As the oncology field moves away from treating cancer according to its tissue of origin (i.e. breast, lung, colon, etc.) and toward a focus on the mutations, translocations and other molecular factors underlying each patient's disease, the need for individual cancer genome analysis becomes clear. And doctors shouldn't have to send each patient's tissue sample to 50 different labs to get answers - there needs to be a single, comprehensive test for all cancer patients, Borisy explained.

The technology already exists. Scientists at a few leading cancer research centers perform those analyses as academic queries, but not as a part of patient care. There are also specialty service providers like CollaboRx Inc., which will conduct a cancer genome analysis and advise an oncologist on treatments if the patient can afford the high prices.

Foundation's goal is to make cancer genome analysis "not just academic, not just an expensive boutique service, but connected to the day-to-day world of what's necessary for routine clinical practice," Borisy explained.

That's a lofty goal, but Foundation is drawing on some lofty expertise. The company's founding academic advisors include genomics pioneer Eric Lander, cancer genome expert Todd Golub, OncoMap project leader Levi Garraway and Cancer Genome Atlas investigator Matthew Meyerson, all of whom have ties to the Broad Institute and Harvard Medical School, among other prestigious institutions. Borisy, who co-founded CombinatoRx Inc., brings business sense - as does Foundation board member and Third Rock partner Mark Levin, who served as founding CEO of Tularik Inc., Cell Genesys Inc., Abgenix Inc. and Millennium Pharmaceuticals Inc.

Borisy said Third Rock and the academic founders had been laying their plans for several years. Indeed, at last year's annual meeting of the American Association for Cancer Research, Lander said in a plenary talk that he hoped to see complete cancer genome analyses become a routine part of research within five years and a standard of care for patients within 10 years.

With genome sequencing technologies evolving at breakneck speed and a number of cancer genome mapping projects under way, the Foundation team decided to put their plans into action. They incorporated last fall and have now closed their Series A round. Borisy said the start-up received "tremendous interest" from other investors - of both the traditional venture capital and the strategic partner ilk. Once the company is up and running, he expects to expand the round.

But how does Foundation actually get up and running? How do you take the first steps down such an ambitious path?

Borisy said the company is currently "engaging in a very broad listening tour." They're talking to oncologists, insurance companies and drug makers to figure out how to create a system that would work for everyone.

Foundation is also hiring - Borisy expects to have between 30 and 40 employees on board by the end of the year. And genome sequencing expertise is only one part of the equation, he told BioWorld Today. Foundation's expertise needs to include cancer biologists who can understand the role that genetic mutations play in cancer and how to select appropriate treatment regimens. The company will also require clinical oncologists to drive the massive undertaking of validating the test so that doctors will trust its results. And they'll need information technology experts to figure out how to sort through all the resulting data and present them in a way that is useful to oncologists.

"There's a cross-disciplinary expertise that is necessary - this is what we are building," Borisy said.

But while Foundation may be assembling the technology and scientific expertise needed to achieve its goals, can it navigate the intellectual property and legal wranglings to make a single test for all cancer patients a reality?

Borisy maintained that Foundation values intellectual property. He declined to get into specific debates on gene patenting or on the recent district court decision invalidating Myriad Genetics Inc.'s patent claims related to the BRCA1 and BRCA2 genes. Yet he did note that "society is saying to us as an industry: 'You guys figure this out and make it workable.'"

He also added that the majority of the information Foundation needs is in the public domain, and the majority of the rest has been made readily available through licensing. While Foundation will have its own patents and trade- secrets, he predicted that in the long term, the company's value will be driven predominantly by clinical validation. After all, anyone can say they are testing for the same things, but not just anyone can prove their test is trustworthy.

Of course, it's hard to look too far into the future on a company like Foundation. Discussion of adoption curves and exit strategies is premature considering that much of the technology Foundation may ultimately utilize has yet to be discovered, the rules that govern that technology are in flux and even the health care system as we know it is evolving.

"This is an extraordinarily complex company to build," Borisy said. "We will continue to build the right team at the right time with the right approach to make it happen."