Three vendors applied their variant calling and interpretation pipelines to the same tumor NGS panel data and came up with overlapping but different results.
The company is eyeing a launch for its IVD kits at the beginning of next year, as evidence grows for the integration of TMB analysis into the clinical care of cancer patients.
The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.
The effort, sponsored by two therapeutics companies, is providing no-cost genetic testing and counseling for people with Duchenne who otherwise couldn't afford it.
The firm is in the midst of evaluating its strategic options and has hired Raymond James to assist in the process, which could include the sale of the firm, it said.
For full-year 2017, the company reported $152.9 million in revenues, up 31 percent over 2016.
The funding will help the Canadian cancer genomics firm expand distribution of its tumor tissue hotspot test, and development of its newer liquid biopsy assay.
The group now plans to run the 32-gene panel in clinical trials to demonstrate its utility and make the case for offering it within Canada's healthcare system.
The firm has secured NYS approval for its sequencing-based 32-gene Fertilome assay, which it originally launched in January.
The company beat analyst estimates on both the top and bottom line and reported a 50 percent year over year growth in clinical testing volume in Q3.