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.
Guardant said Guardant360 is the first liquid biopsy permitted by New York's CLEP, and the approval means the test can be ordered in all 50 states.
The coverage decision limits the test to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue-based testing.
The money will fund a new plan to sequence tumor DNA from more than 1 million cancer patients. The firm also announced a new JV in Asia, the Middle East, and Africa.
The Palo Alto-based firm plans to use the money to further validate its non-invasive, early cancer detection technology.