The agency said that the proposed exemption would apply only to cytometry instruments that are used for counting or characterizing cells.
The firm's CEO told investors at the JP Morgan Healthcare Conference that in addition to driving growth of its sepsis test in the US, Accelerate is eyeing expansion into China.
The company expects to miss the consensus Wall Street revenue estimates for Q4 and full-year 2018.
A technology called Stratification of Adverse Pathology, or STRAT-AP shows potential to risk-stratify patients using phenotypic biomarkers.
The company is developing a new gold standard comparator test after it encountered problems with typical culture methods it used in developing a new pneumonia assay.
The FDA cleared BD's test for detecting carbapenemase-producing organisms, which can be used by hospitals to contain the spread of antimicrobial resistance.
The miniature analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood.
The company is in discussions with the FDA about a new test being developed for severe bacterial pneumonia and expects to start a clinical trial in Q1 2019.
Celcuity's HER2 assay will be used to assess Puma Bio's Nerlynx and chemotherapy on patients with early-stage triple-negative breast cancer.
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.