The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."
CareDx claims that Eurofins Viracor infringes on its patent related to noninvasive monitoring of organ transplant rejection through cell-free DNA analysis.
The company said the money from the transactions will help it boost adoption of its ConfirmMDx and SelectMDx prostate cancer tests with urologists and payors.
Quest said it will not acquire True Health's facilities or staff and that it expects the buy to expand the reach of its cardio-metabolic diagnostic services.
The firm said it anticipates launching the platform in Europe next year and completing its first round of external financing in the first quarter of 2020.
The firm will offer €4.4 billion of euro-denominated notes and $900 million in dollar-denominated notes. It will redeem another $4.5 billion in outstanding notes.
The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.
The test can be used to help doctors in the emergency room diagnose heart attacks faster and more accurately than other troponin tests on the market, Abbott said.
The companies will use Foundation Medicine's FoundationOne CDx test as the baseline to define a set of unique variants that the codeveloped assays will monitor.
The FDA said its new pathway will address diagnostic devices for diseases that are less serious than those associated with its Breakthrough Devices Program.
The company said its APAS Independence platform can process 200 culture plates per hour and automatically remove nonsignificant plates from the workflow.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The funding will be used in part for the ongoing commercialization of the company's EarlyCDT Lung test for lung cancer and the development of new tests.
