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.
The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
While canine genetic testing providers bemoan a lack of quality standards, they disagree on what specific rules labs should follow.
The newly launched RT-PCR-based molecular diagnostic kits are designed for use in monitoring post-transplantation and immunosuppressed patients.
The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.
The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.
The test measures hepatitis B viral DNA and is intended to be used to assess prognosis and response to antiviral therapies.
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 firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.
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 test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
The endorsement is the agency's first through the Human Variant Database Program, for which it released final guidance earlier this year.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
The disease is an inherited form of muscular dystrophy characterized by a repeat expansion of 50 CTG trinucleotides or greater in the DMPK gene.
The molecular test detects a form of herpes virus that can infect newborns and cause deafness.
Two researchers are calling for education for scientists on defending facts.
Researchers were among those who marched in London this weekend to call for another vote on Brexit.
Duke has agreed to pay $112.5 million to settle a lawsuit regarding its handling of data falsified by biologist Erin Potts-Kant.
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.