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Guardant, Mirati Enter Collaboration

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Guardant Health, the market leader in liquid biopsies, and Mirati Therapeutics, a targeted oncology company focusing on genetic and epigenetic drivers of cancer, have announced that they have entered into a collaboration for the development of a circulating tumor DNA (ctDNA) assay for Mirati's kinase inhibitor, glesatinib.

Guardant360 is a blood test that identifies multiple tumor mutations across all four types of genomic alterations: single nucleotide variations, copy number amplifications, indels, and fusions. As part of the collaboration with Mirati, Guardant360 will be used to screen NSCLC patients for certain genetic alterations to the MET pathway in order to identify the patients most likely to respond to glesatinib. Specifically, the assay will sequence for patients with certain MET mutations and MET gene amplification. This plasma-based assay offers a less invasive, and potentially safer, approach to assess tumor genetics by avoiding the risks associated with tumor biopsies. This is an important factor for lung cancer patients for whom repeated tumor biopsies are often not possible. The ability to perform multiple ctDNA blood assays will also facilitate the identification of key resistance mechanisms.

The collaboration will use Guardant360 in Mirati's Phase 2 clinical trial of glesatinib in patients with NSCLC. In a separate press release today, Mirati announced the initiation of the Phase 2 trial. If successful, the collaboration could result in a regulatory submission and approval of the Guardant360 platform as a companion diagnostic for glesatinib.

"Guardant360 is particularly useful for cancers driven by evolved mutations like MET amplifications. The non-invasive assay allows oncologists to quickly and easily monitor patients and their response to targeted therapies," said Guardant Health co-founder and CEO, Helmy Eltoukhy. "Mirati is a pioneer in the field of targeted therapeutics and the company is known for being an innovator. Today's collaboration will allow us to leverage our unique technology to provide more patients access to targeted trials, and potentially accelerate clinical studies, making cancer a more manageable disease."

"Identifying patients with MET mutations or MET gene amplification is the key to our patient selection strategy. Clinical data has shown that these are the patients most likely to respond to glesatinib," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "Collaborating with Guardant on a ctDNA assay means that we expect to be able to detect these mutations in a blood sample. This will enable the more than 30% of non-small cell lung cancer patients, who have insufficient tumor tissue for biopsy, to be screened for genetic alterations that may be driving their cancer and to seek treatment that could lead to improved outcomes.