Research & Development
Policy & Regulation
Trends & Finance
Policy and Regulation: Page 2
AMP update: Roche obtains regulatory approvals for six assays on compact MDx system
The approvals are part of an overall plan to make the broad menu of tests already running on its high-throughput Cobas 6800/8800 MDx systems also available on the more compact Cobas 5800.
November 7, 2022
Roche to launch compact MDx instrument at AMP meeting, obtains FDA premarket approval for HIV assay
Both the assay and system will be available in U.S. markets in Q4. Roche will showcase both this week at the Association for Molecular Pathology (AMP) 2022 Annual Meeting.
November 1, 2022
FDA proposes updates to breakthrough devices guidance focused on reducing disparities in healthcare
The agency is proposing updates to clarify considerations in designating devices, including eligible devices that may benefit populations impacted by disparities in healthcare.
October 20, 2022
CDC’s five-day isolation period after COVID infection may not be sufficient
Stanford University researchers have published findings indicating that rapid antigen tests remained positive in 27% of the participants in a study after seven days of isolation.
October 19, 2022
Nucleix announces CLIA certification, CAP accreditation for San Diego laboratory
Nucleix announced that it has received CLIA certification and CAP accreditation for its San Diego-based clinical laboratory.
October 19, 2022
SQI Diagnostics nabs Health Canada approval for IL-6 triage test to detect COVID severity
By testing for the presence of IL-6, the tool helps identify patients at greatest risk of a severe inflammatory response from a cytokine storm, which is associated with the worst patient outcomes.
October 17, 2022
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
C2N Diagnostics launching next-generation blood test for Alzheimer's disease detection
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Aspira announces commercial launch of blood-based ovarian cancer risk assay
Sherlock Biosciences secures funding to further develop CRISPR testing platform
Cleveland Diagnostics nabs Medicare coverage for test that interrogates PSA structural variants
In large, prospective multicenter studies of men scheduled for biopsy, IsoPSA demonstrated greater diagnostic accuracy than PSA alone in identifying patients with high-grade cancer
October 13, 2022
Menarini Silicon Biosystems liquid biopsy tests issued CPT-PLA codes
The new CPT PLA codes are Cellsearch Circulating Multiple Myeloma Cell (CMMC) assay - 0337U and Cellsearch HER2 Circulating Tumor Cell (CTC-HER2) assay - 0338U.
October 13, 2022
Proscia launches expanded digital pathology platform for primary diagnostic workflows
The product brings together new features to help laboratory networks transition to 100% digital diagnosis and shift away from microscope-based pathology, the firm said.
October 12, 2022
Thermo Fisher Scientific launches CE-IVD marked panel to detect most common gastrointestinal bacteria
With results available in about two hours at greater than 98% sensitivity and specificity, the panel compares favorably with the culturing of samples in a lab, which can take up to two weeks, the firm said.
October 10, 2022
Abbott nabs first FDA EUA for a commercial test kit to detect monkeypox
Abbott Molecular received an EUA for an RT-PCR test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection.
October 7, 2022
Boston Cell Standards nabs FDA clearance for IHC test panel to evaluate breast cancers
Boston Cell Standards on Thursday announced that the FDA has granted 510(k) clearance for the company’s IHControls panel for evaluating breast cancers.
October 6, 2022
Page 2 of 39