The clearance by the Chinese NMPA means the instrument can be used as a clinical diagnostic tool in hospitals, laboratories, and clinics in China.
Clinical researchers at AACR discussed a wide range of approaches focusing on several different potential use-cases in the detection or assessment of early cancers.
The system is used to automate sample preparation steps for assays that are run on BD's FACSLyric clinical flow cytometer.
For the Evry, France-based company, the grant will support its vision of making its technology available as a platform for running oncology assays.
The agency said that the proposed exemption would apply only to cytometry instruments that are used for counting or characterizing cells.
NeoGenomics estimates that the more than 2,000 community oncologists represent a $2.5 billion testing opportunity. Its CEO called the segment a "strategic priority."
The classification indicates a reasonable probability that the use of, or exposure to, a recalled product will cause serious adverse health consequences or death.
The miniature analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood.
Precision Pathology will develop the CyPath Lung test for early-stage detection of lung cancer as an LDT for commercial sale by the first-quarter of 2019.
Questions posed by CMS about expanding PAMA data collection expose a rift between labs and other industry stakeholders over who should report lab prices.