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Guardant Health to create a new 500-plus-gene liquid biopsy panel with several leading pharmaceutical companies to accelerate clinical trials and drug development.

Guardant Health announced that it has entered into separate agreements with AstraZeneca, Merck (known as MSD outside the United States and Canada), Merck KGaA, Darmstadt, Germany, and Pfizer Inc. to develop a 500-plus-gene liquid biopsy panel designed to help drug companies speed clinical trials and the development of targeted cancer drugs and immunotherapies.

The 500-plus-gene panel is expected to be the industry's largest commercially available liquid biopsy panel. It will leverage Guardant Health's patented Digital Sequencing platform along with the latest innovations from Guardant360, Guardant Health's industry leading comprehensive liquid biopsy, to create an expansive panel optimized for the clinical and pre-clinical drug investigations of its partners. Guardant Health plans to introduce the test in mid-2017, followed shortly thereafter by a CLIA-certified version for Guardant Health's biopharma collaborators.

"With Guardant360, we have pushed our Digital Sequencing platform to the biological limits of DNA sequencing sensitivity. In a number of cases, we are now confidently detecting a single molecule of mutant circulating tumor DNA in a 10mL tube of blood drawn from an advanced cancer patient," said Helmy Eltoukhy, Guardant Health CEO and co-founder. "Now we are applying this same underlying technology to ten times as many genomic targets in an effort to speed drug development. The result for which we are aiming is that effective drugs will get to market faster and help patients sooner." 

The number of targeted agents in clinical trials drives the need for broad molecular testing. But the industry's historic reliance on tissue biopsies to acquire tumor DNA has hampered clinical trials, as tissue is frequently unavailable for sequencing, and acquiring fresh specimens through invasive biopsies can be complex and expensive.

The 500-plus-gene blood test from Guardant Health is expected to enable investigators to screen patients for multiple clinical trial options from a simple blood draw, and allow low-risk, real-time monitoring of tumor response and the evolution of tumor resistance. The test will also support analysis of tumor mutational burden for use with immunotherapy trials.

"This could potentially be a very important tool for anyone conducting clinical trials in oncology," said Dr. John Heymach, chairman of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center. "With one test, we could screen patients for virtually every targeted therapy clinical trial available, monitor their response, and determine how the tumor evolves if it develops resistance to treatment. This panel may ultimately be of great use in helping guide the use of immunotherapy as well."

Guardant Health is focused on conquering cancer by using its blood-based assays, data sets, and advanced analytics. The company has raised more than $200 million from venture capital firms. Its first product, Guardant360, came to market in 2014. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.

(Source: PR Newswire)

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