Date: 2015-12-21
Type of information: Development agreement
Compound: circulating tumor DNA (ctDNA) assay for glesatinib
Company: Guardant Health (USA- CA) Mirati Therapeutics (USA- CA)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism: blood test/gene test. Guardant360 is the first CLIA/CAP-certified comprehensive next generation sequencing-based liquid biopsy test indicated for cancer genomics. The 70-gene blood test is used in advanced cancer patients with visceral solid tumor cancers or metastases, and interrogates all four types of genomic alterations. The test is used to prevent repeat invasive biopsies when cancer has progressed or recurred despite treatment, or when an initial biopsy is unobtainable or has insufficient tissue. It is the only ctDNA test that includes all NCCN somatic genomic targets in a single test. Unlike hotspot tests, Guardant360 sequences complete exons so as not to miss uncommon or rare mutations. Based on the tumor genomic profile, clinicians receive a report of actionable genomic alterations and a list of FDA -approved treatments and clinical trials for which the patient could be eligible.
Disease: non-small cell lung cancer (NSCLC)
Details: * On December 21, 2015, Guardant Health, the market leader in liquid biopsies, and Mirati Therapeutics, a targeted oncology company focusing on genetic and epigenetic drivers of cancer, 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.
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