This report evaluates the clinical utility of cell-free DNA (cfDNA) (formerly NIPS, NIPT) screening for fetal sex chromosome aneuploidy (SCA) in women with singleton or twin pregnancies.
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Inclisiran is a subcutaneously administered, investigational RNA interference (RNAi) therapeutic that decreases hepatic synthesis of proprotein convertase subtilisin kexin type 9 (PCSK9), leading to increased low-density lipoprotein (LDL) receptor expression on the hepatocyte cell surface and subsequently to greater removal of LDL-C from circulation.
Tivdak (tisotumab vedotin-tftv) is an intravenously administered tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Focus of the Report: This report focuses on transperineal template prostate (TTP) biopsy as an alternative to standard transrectal ultrasound (TRUS) biopsy for purposes of confirming candidacy for active surveillance or for restaging during active surveillance in men who previously had biopsy results that were positive for favorable-risk pros…
Lecanemab (formerly, BAN2401) is an investigational, intravenously administered anti-amyloid beta (Aβ) protofibril antibody proposed for the treatment of early Alzheimer disease.
This report evaluates the analytical validity, clinical validity, and clinical utility of the GeneSight Psychotropic (Myriad Neuroscience) test.
Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
The OCS Heart is a portable extracorporeal heart perfusion and monitoring system indicated for the preservation of donor-after-brain-death (DBD) donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).
The Vivistim Paired VNS System is an implanted neurostimulator system intended to be used to stimulate the vagus nerve during rehabilitation therapy in order to reduce upper extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
Mitapivat is an investigational oral drug designed to increase the activity of the pyruvate kinase (PK) enzyme in red blood cells. It is proposed for the treatment adults with PK deficiency.