Health and Medical News and Resources

General interest items edited by Janice Flahiff

[Report] Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.


In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

 

January 21, 2015 Posted by | health care | , , , , | Leave a comment

Learn to understand and interpret your body’s language (holiday stress example included)

 

From KevinMD.com article  by SUSAN BIALI, MD on September 9th, 2012

A few weeks ago I was brought in to speak to the staff of a local university. I gave a two hour workshop, which is even more fun for me than giving a keynote as I get to interact personally with the audience and draw their stories out. One of the sections of the workshop was about listening to your body. Every person’s body “speaks” to them in a different way; it’s important to pay attention to and learn to understand and interpret your body’s language.

 

When your life is off track, your body will let you know. It starts small, whispering to you through minor ailments such as suddenly developing a rash like eczema, or getting mild tension headaches. If you don’t pay attention and make adjustments it will get louder. You might start catching every cold that’s around, or end up with pneumonia.

This isn’t to say that you necessarily caused any and every medical condition you might end up with; there will always be some health situations that we have no explanation for. Yet there’s no question that when you’re out of balance in your life it’s perceived by your body as a stressor, and that can lead to all kinds of secondary consequences (and physical alarm bells). It’s essential to pay attention to this.

While speaking at that university, I asked the audience members if they had any examples of a time their body let them know that something in their life had to change. A small, pleasant-faced woman raised her hand.

“I got diabetes,” she told us. “There’s absolutely no history of it in our family. It was purely due to stress.”

Chronic excess stress could trigger diabetes in a variety of ways: reaching for sugary snacks or other poor food choices to temporarily calm and comfort; lack of time to exercise and maintain a healthy weight; being chronically sleep-deprived (even brief sleep deprivation triggers a pre-diabetic state); or having constantly elevated stress hormones that raise blood sugar.

I asked her what the circumstances were that had made her life so stressful.

“I’m a victim of the sandwich generation,” she said. “I was taking care of my kids, my parents, and everybody else. When I got diagnosed with diabetes, I knew something had to change. I was the person who everyone else came to for Thanksgiving, Christmas, everything. The year I got my diagnosis I told them that if they wanted to eat turkey they could make it themselves, I wasn’t lifting a finger. They didn’t like it at first, but I had no choice. Everything’s so much better now. I made lots of positive changes that were way overdue, and my blood sugar has gone back to normal.”

 

 

 

September 11, 2012 Posted by | Consumer Health, Psychology | , , , , , | Leave a comment

   

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