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FDA Warns about Unapproved Genetic Testing

Regency Nursing and Rehabilitation Center

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Friday, 24 May 2019 14:11
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FDA Warns about Unapproved Genetic Testing

The humble fruit fly, drosophila melanogaster, is not merely a kitchen pest. Its short lifecycle and large number of offspring have made it a favorite for genetic research, including the massive Human Genome Project (HGP).

The fly’s genes were studied and mapped in the early 1900s, but it was not until the 1990s that international collaboration allowed the mapping all human genes, collectively known as the human “genome.” The project was completed in 2003, with over 20,000 human genes identified.

Since 2003, this new data has allowed the blossoming of genetic research and genetic counseling. It has also produced a new industry: “over-the-counter” genetic testing. With just a small sample of genetic material, usually obtained through a swab of saliva, a variety of companies are ready to sell you a “genetically-based prediction” of your response to a variety of medications. There’s just one problem: the tests are not necessarily accurate.

While genetically tailor-made treatments for various conditions are currently in the research phase, and perhaps one day we truly will be able to find out useful information about our health at low cost, the US Food and Drug Administration (FDA) warns that today is not that day.

The FDA published an alert to consumers and clinicians that the agency has not reviewed many of the claims made by genetic laboratories, and that those claims may not be backed by scientific evidence. The FDA warns of the “inappropriate treatment decisions and potentially serious health consequences” for people who rely on these tests, and recommends that no one change their medication based on an over-the-counter genetic test.

The FDA also announced that they are investigating developers who use misleading advertising to sell genetic tests. The agency requests that anyone who has a problem with any laboratory test files a report via Medwatch, the FDA’s Safety Information and Adverse Event Reporting Program.

At the Regency Nursing and Rehabilitation Centers, we embrace innovation, but do not fall prey to trendy promises. We care for our residents with clinically-proven programming, nutritious and delicious meals, and, of course, compassionate care from specially trained caregivers and therapists.

We pride ourselves on offering the very best of care in a patient-centered environment. This means always listening to our residents and patients and respecting their capabilities, while helping them to achieve maximum functionality and independence. And always maintaining the highest professional and quality standards in our staff and our facilities. Our 25 years of excellent care have led to us being awarded a Best Nursing Homes award by US News & World Today, a 5-Star rating by USA Today, and an A+ rating by the Better Business Bureau, among many other awards.

Contact us by clicking here to see which of our three facilities will best meet your needs or the needs of your loved one.

Judah

The Regency organization has become synonymous with the best in senior healthcare and has garnered a well deserved reputation for its unsurpassed commitment to its patients and residents.

The Regency Nursing and Rehabilitation Centers and Facilities throughout New Jersey have achieved numerous industry ‘gold standard’ benchmarks and have received accolades from all corners of the HealthCare community.

Welcome to our website at www.RegencyNursing.com!

Warm Regards,

Judah

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