The firm is seeking damages and various injunctions, citing 11 different counts of fraud, breach of contract, tortious interference, and unfair competition.

The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.

The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.

At the Business in Personalized Medicine Summit last week, the company also said it has generated promising data from a pilot study for early detection of lung cancer.