Just 18 months after its launch, cancer diagnostic startup Foundation Medicine
has already developed a clinical diagnostic test, forged partnerships
with several pharmaceutical companies, and discovered a number of novel
mutations that may point toward new drug treatments for cancer.
Cancer reader: Foundation Medicine has developed a diagnostic
test for cancer that reads the genome sequence of hundreds of
cancer-linked genes. The results help oncologists pick the best drugs
for that patient.
The company is at the forefront of a growing trend in cancer:
choosing drugs based on the genetic profile of a patient's tumor cells.
The plunging cost of gene sequencing means scientists can read the
entire genome of an individual's cancer, leading to the rapid discovery
of more and more cancer-linked mutations. Foundation Medicine is putting those findings—and cheap sequencing technology—to work to detect these mutations in newly diagnosed cancers.
The startup was formed last year by a handful of cancer and genomics experts in Boston, including genomics pioneer Eric Lander, with funding from Boston-based venture capital group Third Rock Ventures. They have since raised $33.5 million from several investors, including Google Ventures.
While most cancer diagnostics focus on individual genes or specific
mutations, Foundation Medicine developed a diagnostic test to read the
entire sequence of hundreds of cancer-linked genes. The company has yet
to finalize the price of the test, but says it will be similar to the
cost of testing five or six individual molecular markers.
Foundation Medicine has so far processed several thousand tumor
samples provided by academic medical centers, pharmaceutical companies,
and clinical oncologists. The analysis detects whether the individual
has mutations tied to existing drugs—both drugs that are approved for
the patient's specific cancer, and those that are approved for other
conditions. The test, which takes about two weeks, will also highlight
whether a patient has mutations that make him a candidate for
experimental drugs in clinical trials. While the test is currently
available to some oncologists, the company doesn't plan an international
launch until later next year.
The number of genes analyzed in the test will grow as the number of
cancer-linked genes expands. The company will release an updated version
of the test once or twice a year, says Michael Pellini, the company's
chief executive officer. "That's why our work with pharma and academic
medical centers is so important, because we get great insight into new
therapeutics coming down the pike," he says. "If a new therapy targeting
a specific molecular profile is getting ready for human testing, we
want to make sure we are adding that gene to our test."
A number of pharmaceutical companies are using the test in clinical
trials of new drugs. For example, if a study of a specific new drug
failed to show a benefit in the patient population overall but did
appear to work in a subset of patients, researchers can use Foundation
Medicine's test to determine if there is a particular genetic alteration
that predicts who is most likely to respond.
Companies are also using the technology to direct patients into
specific studies of drugs designed to target different mutations; it can
often be difficult to enroll enough patients in such studies.
Furthermore, if researchers collect multiple tumor samples from the same
patient over time, they can use the test to understand how the tumor
evolves and try to predict why one person's tumor might recur more
quickly than another's.
Pellini says at least two pharmaceutical companies are considering
using the technology in all cancer clinical trials going forward.
"Pharma's willingness to accept this type of molecular approach has been
my single greatest surprise since joining Foundation Medicine," he
says. Historically, the pharmaceutical industry has been reluctant to
test drugs in only a subset of patients, because this limits the number
of people who might buy the drug.
"There has been a transformation among many pharmaceutical companies
to where they understand that targeted therapeutics is the new
paradigm," says Pellini. Targeting clinical trials to only the patients
who are most likely to respond to a drug makes it faster and cheaper to
show that a drug works. "As everyone works to turn cancer into a chronic
disease, as an industry, we will have the ability to treat patients for
years rather than months—pharma has caught on to those concepts," he
says.
Because Foundation Medicine's test is based on sequencing genes,
rather than detecting known mutations, it can also find novel genetic
changes. "As a by-product, a lot of novel discovery is coming out of
these efforts," says Pellini. "We are identifying novel gene fusions,
translocations, and mutations, many of which have clinical
significance."
For example, researchers at Foundation Medicine identified a genetic
translocation—where a segment of DNA is flipped around—in cancer tissue
from a patient with non-small-cell lung cancer. Subsequent studies found
that this mutation, which lies in a part of the genome that is being
targeted by pharmaceutical companies, is present in about 5 percent of
small-cell lung cancers. Pellini says the company is still working on
how to deal with such new discoveries. "We are not a therapeutic
company, and our primary interest tends to be on the diagnostic side,"
he says. "But we recognize that some findings may have strong
therapeutic implications."
By Emily Singer
From Technology Review
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