Researchers found that diagnostic autism NGS panels offered by 21 clinical labs have very little overlap and are working to create a standardized gene list.
The working group reviewed data to identify a minimum of 34 commonly mutated genes that should be included in pan-myeloid targeted panels.
The startup's first test focuses on diagnosing 60 conditions for which treatment is available.
The NGS-based test improves on a previous PCR-based version and detects circulating DNA from Epstein Barr virus that is shed from cancer cells.
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.