In a technique called spindle nuclear transfer, the nucleus of a donor egg is removed and the DNA of another woman’s egg is injected.
The FDA is taking a hard stance on a controversial fertility technique that involves genetically modifying embryos.
The New York-based doctor who helped a couple have a child using DNA from three people has been told by the U.S. Food and Drug Administration to stop the clinical trials meant to test the technique.
Last year, John Zhang, the founder of New Hope Fertility Center, pioneered a new type of in-vitro fertilization that involves transferring DNA from the mother’s egg into a hollowed-out egg donated by a younger woman. But the work violates federal legislation that forbids implanting genetically modified embryos, so after fertilizing the egg with the father’s sperm, Zhang went to Mexico, where he inserted the embryo into the mother’s womb. A healthy baby boy was born in April 2016.
FDA sends Zhang a letter
Zhang then requested a meeting with the agency to ask permission to carry out a clinical trial using the technique in the U.S. The agency subsequently denied the meeting. Zhang has since been marketing his fertility procedure to women with certain genetic diseases and older women having trouble conceiving through a new company called Darwin Life. Modifying embryos in a lab is not illegal under U.S. law as long as federal funds are not used to carry out the work. But implanting one in a woman’s womb so that a baby can develop is prohibited.
23andMe first debuted direct-to-consumer tests meant to predict disease in 2013, but the U.S. Food and Drug Administration quickly clamped down on that and told the company to stop marketing the tests, saying they could be inaccurate and confusing to consumers.
However, the company was vindicated earlier this year when the FDA revised that decision, declaring 23andMe could sell tests that estimate customers’ risk of certain disease, as long as they don’t purport to diagnose any disease.
Early this year, Illumina, the manufacturer of most of the world’s DNA sequencers, unveiled its newest, most efficient machine, NovaSeq, which can sequence as many as 48 entire human genomes in two and a half days, according to the company. Illumina claims the ultra-fast machine will usher in the $100 genome and will open the door for researchers to cheaply sequence DNA in search of rare genetic variants that cause disease.
Sophia Genetics is taking a big-data approach to DNA. The Swiss company is using AI algorithms to continuously learn from thousands of patients’ genomic data. Partnering hospitals take patient samples and run them through a DNA sequencer. The Sophia system sifts through that genetic information to identify mutations in a patient’s genome. The technology is said to quickly and more accurately diagnose conditions like cancer, metabolic disorders, and heart disease.
This is not science fiction folks. More Here
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Apple is working with U.S. researchers to launch apps that would offer some iPhone owners the chance to get their DNA tested, many of them for the first time, according to people familiar with the plans.
The apps are based on ResearchKit, a software platform Apple introduced in March that helps hospitals or scientists run medical studies on iPhones by collecting data from the devices’ sensors or through surveys. ResearchKit launched with apps aimed at studying asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease, but now scientists can develop programs that gather information about other medical conditions. Tens of thousands of users have already submitted data to ResearchKit, including 11,000 to a Stanford University cardiovascular trial in the app’s first day. The raw data and interest is there, though the quality of the information sent via ResearchKit is still up in the air, for now.
In two initial studies planned, Apple will not directly collect or test DNA itself. That will be done by academic partners. The data would be maintained by scientists in a computing cloud, but certain findings could appear directly on consumers’ iPhones as well. Eventually, it’s even possible consumers might swipe to share “my genes” as easily as they do their location. Apple is closely involved in shaping initial studies that will collect DNA. One, planned by the University of California, San Francisco, would study causes of premature birth by combining gene tests with other data collected on the phones of expectant mothers. A different study would be led by Mount Sinai Hospital in New York.
Apple is concerned whether consumers are even interested in their DNA. So far, most people still have no real use for genetic data, and common systems for interpreting it are lacking as well.
I wonder how far will they go. Right now you have scientists editing human embryos using CRISPR to correct DNA of the BRCA1 gene. Whats next, the so called perfect baby with high intelligence and hair color.. There are three centers in the United States currently working on human germ-line engineering., as are scientists in China, in the U.K., and at a biotechnology company called OvaScience, based in Cambridge, Massachusetts, that boasts some of the world’s leading fertility doctors on its advisory board. Some have dropped out of the research. Some say people might pick and choose eye color and eventually intelligence causing a public uproar. A dozen countries have banned Germ-line engineering