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Guardant Health

The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.

The recent agreement between Freenome and Biognosys suggests a role for proteomics as developers of genomic-based cancer detection tests look beyond ctDNA.

The companies also agreed to establish a working group to explore the development of standard formulas and definitions for the validation of genomic profiling assays.

Among companies whose tests were greenlighted by the FDA last month, Quidel received clearances for a test to detect and differentiate influenza types A and B, and for a separate test for Lyme disease.

Guardant Health said that its Guardant360 liquid biopsy assay has received expedited access pathway designation from the US Food and Drug Administration.

Several of the top molecular diagnostic firms presented at the JP Morgan Healthcare Conference on Monday discussing product portfolios, FDA clearances, and plans for 2018.

Technologies gained one of their first solid footholds in the clinical care of cancer patients with adoption into the treatment paradigm of lung cancer, while researchers turned their eyes to proving utility in other niches.

Guardant is providing its Guardant 360 CDx test for a clinical trial of Merck's small molecule, c-Met kinase inhibitor called tepotinib.

Guardant is alleging that Foundation's advertising of its own products has harmed both Guardant and cancer patients.

The belief among genomics experts that one day drugs would be given based on genomic abnormalities that cut across tumor types became reality this week.

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