SAN FRANCISCO, May 26, 2016 /PRNewswire/ -- Guardant Health
announced today the launch of an ambitious initiative, Project
LUNAR, which will extend the technology behind the company's
market-leading comprehensive liquid biopsy, Guardant360, into
early-stage cancer detection.
The company is partnering with leading academic, industrial, and
patient advocacy groups to study what would be a novel,
first-in-class technology.
"The existence of a minimally invasive, highly sensitive and
specific test for early-stage cancer holds the promise of a
universal screening test that could change the face of cancer
treatment forever," said Guardant Health co-founder and CEO
Helmy Eltoukhy, PhD. "In fact, the
development of such a test has been Guardant Health's goal from day
one. We started with late stage disease, and over the last four
years have worked methodically through iterative technology
development to arrive at this point. We understand that with any
promise of this magnitude comes a responsibility to fully
understand its implications, so we continue to bring in experts
from advocacy, academia, industry, and public health to support our
efforts."
Oncologists and researchers have long sought a minimally
invasive, highly sensitive and specific multi-cancer test as a more
effective way to catch cancer in its earliest stages, when
treatment and prognosis are most promising.
"As a BRCA-carrier with a
family history of pancreatic cancer, I know just how
important a highly sensitive and specific test can be for a
patient," said Dr. Pamela Munster, a
UC San Francisco clinical oncologist and co-director of the Center
for BRCA Research at UCSF, and one of the Principal Investigators
of the LUNAR-Ovarian study. "Particularly for cancers where
prophylactic surgeries may not be acceptable, early detection can
save lives and can also alleviate anxiety, as well as guide
specific screening. Cancer prognosis is nearly always better when
the disease is detected early."
LUNAR is an umbrella protocol that Guardant Health is launching
with researchers from the Massachusetts
General Hospital, Perelman School of Medicine at the University of Pennsylvania, the Robert H. Lurie
Comprehensive Cancer Center of Northwestern
University, UC San Francisco, Samsung Medical Center, the
University of Colorado Anschutz Medical
Campus, and other institutions that will study the ability of
Guardant Health's technology to detect cancer at early stages in
high-risk populations. Guardant Health has already collected
samples from multiple trial sites in breast, ovarian, lung,
pancreatic, and colorectal cancers, with pilot data expected in the
second half of 2016. Guardant expects to enroll thousands of
patients in multi-site, multi-arm prospective clinical trials that
will demonstrate first the feasibility and then efficacy of early
detection of the deadliest cancers, through the integrated use of
cell free DNA, imaging, germline risk assessment, and other highly
complementary technologies.
"The LUNAR technology, with its great sensitivity necessary for
early detection, will establish a new frontier in cancer
diagnostics, allowing use of a biological signal instead of
standard imaging, and possibly one day replacing invasive
procedures," said Dr. Massimo
Cristofanilli, Associate Director for Precision Medicine and
Translational Research at the Robert H. Lurie Comprehensive Cancer
Center of Northwestern University and
Professor of Medicine at Northwestern
University Feinberg School of Medicine, and one of the
Principal Investigators of the LUNAR-Breast study. "The potential
applications in breast cancer and other solid tumors can go far
beyond early detection to monitor the efficacy and detect
resistance to systemic therapies in adjuvant and neo-adjuvant
settings."
The company presented an early proof-of-concept study to the
American Association for Cancer Research in April that demonstrated
its ability to detect cancer in 86% of early-stage colorectal
cancer patients with ultra-high specificity. Project LUNAR (an
acronym for Liquid biopsy Using NGS to Assay high-Risk patients)
will use a newer, more sensitive version of the company's
technology than was used in that trial.
"The knowledge gained from processing tens of thousands of
Guardant360 patient samples has enabled us to iteratively push the
performance limits of our technology to develop an affordable LUNAR
assay that can detect a single mutated DNA fragment among hundreds
of thousands of genome copies," said Guardant Health President and
co-founder AmirAli Talasaz, PhD. "Such a test may potentially have
a clinical sensitivity approaching 90% for many cancer types, and
could be priced in the hundreds of dollars."
Guardant Health has established its advanced cancer product,
Guardant360, as best in class in terms of both sensitivity and
specificity, with validated analytical specificity of 99.9999%.
High specificity is critical when screening asymptomatic people who
are at a high risk for developing cancer.
"False positive findings cause real harm, both in terms of
anxiety and the unnecessary invasive procedures they often result
in, and have been the downfall of many screening methodologies,
especially for lung cancer," said Dr. Anil Vachani, Associate
Professor of Medicine at the Perelman School of Medicine at the
University of Pennsylvania, and one of
the Principal Investigators of the LUNAR-Lung study. "Guardant's
ctDNA approach may provide the positive predictive value we need to
assist in the management of suspicious findings frequently
identified using currently employed imaging studies in oncology
practice."
There are two reasons why Guardant Health expects its approach
to have superb positive predictive value for cancer. First, while
many screening signals, like dense tissue on a scan, or an elevated
protein biomarker like CEA or PSA, are loosely correlated with a
particular cancer, oncogenically-altered DNA is considered to be
the major universal pathogenic driver of the disease. It is causal,
not correlative. Second, Guardant Health's digital sequencing
platform uses advanced molecular biology, novel chemistry, and a
bioinformatics digital inference engine to maximize nucleic acid
yield and nearly eliminate the errors intrinsic to sequencing.
The potential for extremely high specificity is exciting for the
many patient advocacy groups that are learning more about
project LUNAR. Eltoukhy said, "The voice of the patient is critical
in developing screening methodologies that are not only clinically
and scientifically sound, but reflect the real-world needs of
patients. That's why Guardant Health has built an advisory
committee with the Bonnie J. Addario Lung Cancer Foundation,
The BRCA Foundation, Bright Pink, HeritX, and the Lung Cancer
Alliance."
Guardant Health will be kicking off Project LUNAR at an event in
San Francisco on May 26 that
will feature dozens of leading experts and advocates in oncology
including a panel conversation between Dr. Eric Topol, endowed Chair of Innovative Medicine
at Scripps, and many of the project's
collaborators.
About Guardant Health
Guardant Health, headquartered
in Redwood City, Calif., is
focused on developing breakthrough diagnostics that can transform
cancer from a silent killer into a manageable disease. Guardant
Health was founded in 2012 by a team of serial entrepreneurs with
expertise in next-generation sequencing, single-cell genomics and
cancer diagnostics. The team is committed to positively and
significantly impacting patient health through technology that
addresses long-standing unmet needs in oncology.
UC Disclaimer
The information stated above was prepared by Guardant Health and
reflects solely the opinion of the corporation. Nothing in this
statement shall be construed to imply any support or endorsement of
Guardant, or any of its products, by The Regents of the University of
California, its officers, agents and employees.
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