Companion Diagnostics (CDx) Based on Molecular Biology Techniques.

Molecular profiling based on genomic mutations provides clinically important diagnostic and prognostic information. Companion diagnostic (CDx) testing, which is based on targeted drug therapy, is being applied to a variety of molecular diagnostic techniques (e.g.

Insights into post-marketing clinical validation of companion diagnostics with reference to the FDA, EMA, PMDA, and MFDS.

Companion diagnostics are increasing clinical demand globally, regulatory frameworks for clinical validation are strengthening. Post-marketing verification is an important aspect of providing high-quality, personalized treatment to patients because it can ensure long-term safety and effectiveness, while also generating effective risk management and performance evidence. Certain compliance issues related to the requirements for post-marketing clinical trials can potentially impact manufacturers, so it is essential to have a clear understanding of the regulatory process.

Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS.

Companion diagnostics (CDx), which is essential in precision medicine, is changing to a personalized treatment approach. CDx is a test that identifies patients who can benefit from a specific drug and those who experience side effects of drugs for safe and effective treatment. Conversely, when CDx has inadequate diagnostic performance or has not been adequately validated in a particular treatment, treatment prediction based on diagnostic results is not possible.

Effectiveness and safety of a model predictive control (MPC) algorithm for an artificial pancreas system in outpatients with type 1 diabetes (T1D): systematic review and meta-analysis.

Background: The purpose of this study was to assess the effectiveness and safety of a model predictive control (MPC) algorithm for an artificial pancreas system in outpatients with type 1 diabetes.

Methods: We searched PubMed, EMBASE, Cochrane Central, and the Web of Science to December 2021. The eligibility criteria for study selection were randomized controlled trials comparing artificial pancreas systems (MPC, PID, and fuzzy algorithms) with conventional insulin therapy in type 1 diabetes patients.

Repetitive transcranial magnetic stimulation treatment for peripartum depression: systematic review & meta-analysis.

Background: Peripartum depression is a common disorder with very high potential hazards for both the patients and their babies. The typical treatment options include antidepressants and electroconvulsive therapy. However, these treatments do not ensure the safety of the fetus.

Automated classification of dense calcium tissues in gray-scale intravascular ultrasound images using a deep belief network.

Background: IVUS is widely used to quantitatively assess coronary artery disease. The purpose of this study was to automatically characterize dense calcium (DC) tissue in the gray scale intravascular ultrasound (IVUS) images using the image textural features.

Methods: A total of 316 Gy-scale IVUS and corresponding virtual histology images from 26 patients with acute coronary syndrome who underwent IVUS along with X-ray angiography between October 2009 to September 2014 were retrospectively acquired and analyzed.

Estimation of change of bone structures after total hip replacement using bone remodeling simulation.

Background: The principal cause of femoral stem failure is the loosening of the total hip replacement due to bone resorption in the vicinity of the prosthesis (stress shielding). Bone rebuilds its structure continuously according to the daily mechanical stimuli. Therefore, surgical intervention alters the mechanical condition of bone severely.