New test uses PAM50 breast cancer
gene signature discovered by UNC's Perou
A laboratory
testing kit that estimates the risk of breast cancer relapse
in spite of anti-hormone treatment
has received approval from the U.S. Food and Drug Administration (FDA). This
technology is based on a gene signature
known as "PAM50" originally discovered at UNC Lineberger
Comprehensive Cancer Center
by Chuck Perou, PhD, professor of genetics and pathology and
UNC Lineberger member. Additional UNC inventors included Dr. Joel Parker,
research assistant professor of genetics, and Dr. Maggie Cheang, a research associate in
the Perou Lab.
"This approval
marks more than a decade of work with my fellow researchers and highlights the
growing importance of genomic and genetic tests in the oncology clinic,"
said Perou. "This test is the result of data coming from modern,
cutting-edge genomic technologies, and thus it is exciting to see the bench to
bedside story fulfilled."
A team of UNC
researchers and collaborating researchers from three other institutions --
Washington University in St. Louis, the University of Utah and the BC Cancer Agency
-- designed this test that categorizes breast tumors into one of four main subtypes by
looking at the expression of 50 genes.
The four types are luminal A, luminal B, HER2-enriched and basal-like. These
subtype data are then combined with a standard pathology variable to deliver a
"risk of recurrence" score that predicts the likelihood of that
patient's disease returning within the next 10 years. In this way, clinicians
may now be able to accurately identify those low risk patients for whom
standard hormone therapy is sufficient.
"This is an
amazing step in our focus on individualized treatment for our cancer
patients," said Shelton Earp, MD, director at UNC Lineberger. "We are
shifting from looking at the individual cells of a tumor to a sophisticated
analysis into the genetics that drive this disease."
Patients with the luminal A
subtype have a low risk of recurrence and do well with long-term anti-hormone therapy
that reduces or blocks estrogen, which fuels these tumors. But the
other tumor types may require more aggressive measures to prevent relapse,
including chemotherapy and
sometimes investigational drugs. "This is a very important step down the
road towards personalized medicine, and our approach allows us to make this
test available to a global market," said Perou.
The
test, called ProsignaTM and manufactured by NanoString Technologies, comes with
a machine and kit, so patients' tumor samples do not have to be sent to a
single laboratory for analysis. Currently the test is being distributed to pathology labs
around the world and also is approved for use in the European Union.
The
universities jointly hold a pending patent on the technology behind the
Prosigna test and have licensed the technology to Bioclassifer LLC. The
investigators have joint ownership of Bioclassifer LLC, which licensed the
technology to NanoString Technologies.
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