23andMe is back: FDA allows marketing of genetic health risk tests

[Image courtesy of 23andMe]FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of lung and liver disease; early-onset primary dystonia, a movement disorder; factor XI deficiency, a blood clotting disorder; Gaucher disease type 1, a disorder involving organs and tissue; glucose-6-phosphate dehydrogenase deficiency, also known as G6PD, a red blood cell condition; hereditary hemochromatosis, an iron overload disorder; and hereditary thrombophilia, a blood clot disorder. In providing the authorization to 23andMe, FDA also set up a new one-time review process to allow genetic testing companies to get their products to consumers as quickly as possible. 23andMe, for example, won’t need to seek authorizations for additional tests to add to its $199 health and ancestry service, now that it has received the first authorization. Get the full story on our sister site, Medical Design &Outsourcing. The post 23andMe is back: FDA allows marketing of genetic health risk tests appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Diagnostics Food & Drug Administration (FDA) Genomics Molecular Diagnostics News Well Regulatory/Compliance 23andme 23andMe Inc. MedTech Source Type: news

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Authors: Kang SH, Baik SK, Kim MY Abstract BACKGROUND: We aimed to validate Baveno VI and expanded Baveno VI criteria using two dimensional shear-wave elastography (2D-SWE) in compensated advanced chronic liver disease (cACLD) patients with alcohol as the main etiology. METHODS: Clinical data from 305 patients with cACLD who underwent a liver stiffness measurement (LSM) with 2D-SWE and endoscopy were consecutively collected. RESULTS: Among 305 patients, high-risk varix (HRV) was identified in 21.3% (n = 65). The main etiology was alcoholic liver disease (51.8%), followed by hepatitis B virus (29.8%) and hep...
Source: Journal of Korean Medical Science - Category: Biomedical Science Tags: J Korean Med Sci Source Type: research
AbstractRecent series have demonstrated advantages of living donor over deceased donor liver transplantation, with particular benefit for those with low model for end-stage liver disease score. The logic underlying the transplantation of patients before they become too sick is intuitive. It reduces mortality and drop outs from the waiting list and makes transplant surgery less demanding. Those principles have to be balanced with donor safety and transplant benefit for the recipient avoiding early, futile transplantation. The authors report a case of adult to adult right lobe living donor liver transplantation performed for...
Source: Digestive Diseases and Sciences - Category: Gastroenterology Source Type: research
AbstractPurpose of ReviewNonalcoholic fatty liver disease (NAFLD) and its more aggressive form nonalcoholic steatohepatitis (NASH) are a leading cause of chronic liver disease worldwide. Thus far, there are no FDA-approved therapeutic options for NASH. This review discusses relevant and recent findings in the development of pharmacotherapy that targets the metabolic processes implicated in NASH.Recent FindingsSeveral key drugs have been identified across various drug classes. Among inhibitors of de novo lipogenesis, the SCD-1 inhibitor aramchol and the ACC inhibitor firsocostat are the most advanced. Within nuclear hormone...
Source: Current Hepatitis Reports - Category: Infectious Diseases Source Type: research
This study represents a component of an ongoing research project - GENDYS. From the database of this project, we selected 48 patients 56.62+/-14.16 years old who have been examined clinically and using specific scales: Patient Health Questionnaire-9 (for depression), Montreal Cognitive Assessment - MoCA (for cognitive impairment), and a 5-degree analog scale for subjective perception of the severity of the disease. We conducted a descriptive cross-sectional study on patients with depression and cognition evaluated by the above-mentioned scales. We also performed a nested case-control analysis on 20 IDFO patients with and w...
Source: Journal of Medicine and Life - Category: General Medicine Tags: J Med Life Source Type: research
(University of Plymouth) A psychological therapy found to be effective in helping people achieve and maintain weight loss is being trialled to see if it can support patients with chronic liver disease to stop drinking.
Source: EurekAlert! - Social and Behavioral Science - Category: International Medicine & Public Health Source Type: news
Analytical ChemistryDOI: 10.1021/acs.analchem.0c02277
Source: Analytical Chemistry - Category: Chemistry Authors: Source Type: research
Source: Gastroenterology - Category: Gastroenterology Authors: Source Type: research
Our findings identify a novel mechanism of inflammation in the liver. Experiments in cell cultures, mice and human samples show that a specific form of cell death, called pyroptosis, leads to the release of complex inflammatory particles, the NLRP3 inflammasome, from inside hepatocytes into the extracellular space. From there they are taken up by other cells and thereby mediate inflammatory and pro-fibrogenic stress signals. The discovery of this mechanism may lead to novel treatments for chronic liver diseases in the future.
Source: Journal of Hepatology - Category: Gastroenterology Authors: Source Type: research
AbstractObjectivesTo assess the coronary atherosclerosis profile by coronary computed tomography angiography (CTA) in patients with end-stage liver disease (ESLD) due to alcohol-related liver disease (ARLD) evaluated for liver transplantation (LT), in a retrospective matched case-controlled cohort study.MethodsOne hundred forty patients (age 60.6  years ± 9.8, 20.7% females) who underwent coronary CTA were included. Seventy patients with ESLD due to ARLD (ESLD-alc) were propensity score (1:1) matched for age, gender, and the major 5 cardiovascular risk factors with healthy controls. CTA analysis i...
Source: European Radiology - Category: Radiology Source Type: research
This study aimed to determine the diagnostic value of T1 and T2 mapping and extracellular volume fraction (ECV) for the non-invasive assessment of portal hypertension.MethodsIn this prospective study, 50 participants (33 patients with indication for trans-jugular intrahepatic portosystemic shunt (TIPS) and 17 healthy volunteers) underwent MRI. The derivation and validation cohorts included 40 and 10 participants, respectively. T1 and T2 relaxation times and ECV of the liver and the spleen were assessed using quantitative mapping techniques. Direct hepatic venous pressure gradient (HVPG) and portal pressure measurements wer...
Source: European Radiology - Category: Radiology Source Type: research
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