The biotech company focuses on early cancer screening and detection and sells a multi-cancer screening and detection test in China.
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."
The Broad Institute spinout will develop its CRISPR-based Sherlock platform for battlefield-ready diagnostics for infectious disease agents.
Long-term infection with the parasite, which is primarily found in Asia, can lead to a form of bile duct cancer called cholangiocarcinoma.
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.
The device is intended for preparation of stool samples and use with Buhlmann's Fcal Turbo calprotectin test.
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 Simplexa VZV Swab Direct runs on the firm's Liason MDX instrument and has also been submitted to the US Food and Drug Administration.
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 distributor, Bionuclear Puerto Rico, will give T2 access to approximately 64 hospitals in Puerto Rico and the US Virgin Islands.
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.
Under the agreement, the companies plan to offer combined genetic and biochemical testing services out of Blueprint's clinical laboratory in Seattle.
CareDx will use NanoString's new Human Organ Transplant panel to develop HistoMap, a gene expression profiling test to identify allograft rejection.
Seattle-based Adaptive will develop in vitro diagnostic test kits for distribution, which will run on Illumina's NextSeq 550 Dx system.
The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.
The agency has approved the use of Exact's Cologuard test for average-risk individuals aged 45 and older.
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.