Guardant Health Announces Project LUNAR, An Ambitious Multi-arm, Multi-site Umbrella Trial to Study Blood Test for Early Cancer Detection

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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SOURCE Guardant Health