April 11, 2018 9:00 am
On an unseasonably warm February morning, Mark Pierson takes a 20-minute drive to one of Minneapolis’s larger pet shops. Pierson, a researcher in an immunology laboratory at the University of Minnesota, often comes here to buy mice, so most of the staff know him. Today he asks for ten, and an employee fishes them out of a glass box. Pierson requests the smaller mice because they’re typically younger, but he isn’t too picky. They probably all have what he wants: germs.
April 11, 2018 3:00 am
In 2017, the U.S. Food and Drug Administration (FDA) announced a new program for software classified as a medical device. The Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development. Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised. In particular, Pre-Cert may reduce incentives for developers to study the safety and effectiveness of their software products before patients start to rely on them. Although postmarket surveillance can mitigate risks of these products, the FDA does not have as much authority after a product’s widespread use to enforce data collection deadlines. Pre-Cert may also create confusion for patients and physicians, who may believe that marketed products were subject to rigorous study.
April 6, 2018 9:00 am
Once triggered into action, an immune cell overhauls its metabolism, making changes that could be exploited for treatment.
April 2, 2018 1:53 pm
There is increasing demand from the public for direct-to-consumer (DTC) genetic tests, and the US Food and Drug Administration limits the type of health-related claims DTC tests can market. Some DTC companies provide raw genotyping data to customers if requested, and these raw data may include variants occurring in genes recommended by the American College of Medical Genetics and Genomics to be reported as incidental/secondary findings. The purpose of this study was to review the outcome of requests for clinical confirmation of DTC results that were received by our laboratory and to analyze variant classification concordance.
March 29, 2018 9:00 am
The goal is to find one million people in the United States, from all walks of life and all racial and ethnic groups, who are willing to have their genomes sequenced, and to provide their medical records and regular blood samples.
They may choose to wear devices that continuously monitor physical activity, perhaps even devices not yet developed that will track heart rate and blood pressure. They will fill out surveys about what they eat and how much.
If all goes well, experts say, the result will be a trove of health information like nothing the world has seen. The project, called the All of Us Research Program, should provide new insights into who gets sick and why, and how to prevent and treat chronic diseases.
February 26, 2018 9:00 am
The next step is to implant human stem cells into sheep embryos which have been genetically modified so they cannot grow a pancreas, in the hope that human DNA will fill in the missing code. If successful a human pancreas should appear inside the animal’s body. The team is about to apply for permission from regulators to lengthen their experiment to 70 days to see if the human cells really can create an organ.
February 12, 2018 9:00 am
New research is defining the similarities and differences between brain gene expression profiles involved in neuropsychiatric conditions.
January 5, 2018 9:00 am
Technique to knock out mutant gene relies on fatty molecules to deliver CRISPR components to inner-ear cells.
December 19, 2017 9:00 am
In preclinical studies, a vaccine has been shown to induce antibodies that bind to heroin and keep it from crossing the blood–brain barrier. The vaccine, a haptenic heroin surrogate, was conjugated to tetanus toxoid and mixed with liposomes containing monophosphoryl lipid A as an adjuvant. It reduced heroin-induced antinociception and locomotive behavioral changes following repeated subcutaneous and intravenous heroin challenges in mice and rats.
December 14, 2017 9:00 am
Konduros, 53, who runs a bakery and cafe in southeastern Ontario, is one of 10 men in an early-stage trial sponsored by Spark Therapeutics. (The disorder is much more common in men than women.) On Wednesday, researchers reported that a single intravenous infusion of Spark’s novel gene therapy enabled patients to safely produce sufficient clotting factor to prevent dangerous bleeding episodes.