The test combines qPCR and microarray technology to detect carbapenemase-producing enterobacteriaceae, a bacteria resistance to carbapenem antibiotics.
Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.
Foundation Medicine's assay detects genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of tumors.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The assay is designed to quantitate HBV DNA in serum or plasma to assist in the treatment of chronic HBV-infected patients receiving antiviral therapy.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
In PLOS this week: genetic factors influencing inorganic arsenic metabolism and toxicity, a germline variant in the cell adhesion molecule-coding gene DSCAM, and more.
