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Guardant Health to Launch Cell-Free DNA Assay for Cancer Recurrence Monitoring in 2019

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SAN FRANCISCO (GenomeWeb) – Guardant Health plans to launch a research-use only version of a liquid biopsy assay for cancer recurrence monitoring later this month, CEO Helmy Eltoukhy said at the Business in Personalized Medicine Summit in Millbrae, California last week.

During a presentation at the meeting, Eltoukhy provided an update on the firm's program to develop cell-free DNA assays for cancer recurrence monitoring and early detection.

Guardant recently went public, reporting in its first earnings call last month that its third quarter 2018 revenues were up 95 percent year over year, which highlights the broad appeal of the cell-free DNA cancer testing market.

While the firm is best known for its Guardant360 assay, a cell-free DNA tumor profiling assay that assesses 73 genes, it also launched an effort in 2016 to expand into the recurrence monitoring and early detection space under a multi-arm, multi-site trial called Lunar.

Unlike its Guardant360 assay, which is pan cancer, the assays being developed under the Lunar program will focus on lung, colorectal, breast, and ovarian cancer. Eltoukhy noted that the team has been combining genomic profiling with epigenomic profiling to "improve sensitivity" and has made use of algorithms and machine learning technology to "filter out biological noise," but he did not elaborate further on the assay.

He said that the company has been learning from the more than 70,000 Guardant360 assays it has already run, training its algorithms to recognize cancer signals.

In addition, because Guardant uses only a small amount of the total sample it collects to run its commercial test, it has a very large biobank on which it can perform whole-genome sequencing and other analyses. "That's really accelerated the progress we've been able to make," Eltoukhy said.

In a retrospective study with MD Anderson Cancer Center of colorectal cancer patients who had had surgery to remove their tumors, the researchers analyzed blood samples taken immediately after surgery. The Lunar assay detected signs of cancer without prior knowledge of the tumor's mutations in 48 percent of the patients who relapsed, with zero false positives. All of the patients with detected residual disease relapsed within 18 months and had worse survival rates than those without detectable residual disease.

Eltoukhy noted that the initial research version of the Lunar assay would likely be used by pharmaceutical companies in their drug development studies. "When you think about pharma companies that have pipelines of drugs, mostly in the metastatic setting, the opportunity, for both the business and the patients, is moving those drugs to the stage two or adjuvant settings where hopefully, outcomes can be much better," he said.

The company has also generated promising data from a pilot study for early detection of lung cancer, he said, but he did not disclose when it plans to publish that data or its timeline for launching an early detection test.

Meanwhile, the early detection field is rapidly growing. Just last week, Grail launched a new clinical study, in collaboration with University College London, that will focus on early detection of lung cancer. Grail has also presented interim data from its other studies at conferences throughout the year, along with Freenome, which is initially focusing on colorectal cancer.

CellMax Life already offers a colorectal cancer early detection test that is based on circulating tumor cells in Asia, and newcomer Singlera Genomics presented data in October from a study it has been conducting with researchers from Fudan University, making use of blood samples and longitudinal data from a 100,000-person biobank.