[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Commerce that it will issue draft guidance on the regulation of LDTs, and included the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these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)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.

 

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BBC – Future – Should we diagnose rare diseases with smartphones?

English: Biosafety level 4 hazmat suit: researcher is working with the Ebola virus (Photo credit: Wikipedia)

BBC – Future – Should we diagnose rare diseases with smartphones?.

From the 17 October 2014 BBC article

s fear of the Ebola virus escalates, Eric Topol thinks that we’re missing an important weapon. And you just need to reach into your pocket to find it. “Most communicable diseases can be diagnosed with a smartphone,” he says. “Rather than putting people into quarantine for three weeks – how about seeing if they harbour it in their blood?” A quicker response could also help prevent mistakes, such as the patient in Dallas who was sent home from hospital with a high fever, only to later die from the infection.

It’s a provocative claim, but Topol is not shy about calling for a revolution in the way we deal with Ebola – or any other health issue for that matter. A professor of genomics at the Scripps Research Institute in California, his last book heralded “the creative destruction of medicine” through new technology. Smartphones are already helping to do away with many of the least pleasant aspects of sickness – including the long hospital visits and agonising wait for treatment. An easier way to diagnose Ebola is just one example of these sweeping changes.

…

IBM Watson in a Clinical Setting: Replacing Physicians?

Wondering if a computer can ever intuit as a human, no matter how good the programming…

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ScienceRoll

I’m a geek and you know how much I support the inclusion of digital technologies in medicine, healthcare and medical education. At the same time, I always highlight the fact that doctors will be needed for practicing medicine, robots cannot do their job. I know Vinod Khosla thinks otherwise.

Now, after watching the video demonstration of how Watson could help a clinician, I have doubts about a future. We will see how it gets integrated in everyday medicine. I support the IBM Watson project very much, but I hope medical professionals, humans, will always play the major role in the practice of medicine.

See also the Medgadget report.

View original post

Vinod Khosla: Technology Will Replace 80 Percent of Docs

An astonishing proposal.

Yes, computer algorithms are great tools, but they are just that, tools. These tools are only as good as the data and algorithms they include. Our understanding of diseases and diagnosing is not static. Hence these tools will always be imperfect.
Furthermore, I do not believe the workings of the human body can be reduced to algorithms. Individuals are more than the sum of their parts. The relationship between diseases/conditions and wellness is a bit more nuanced than “solving” a problem. Case in point is the relationship of microbes in the gut and how they affect our immune system.

This article so far has drawn 60 comments..many very worth the time of reading.

From the 31 August 2012 post at The Health Care Blog

 I recently viewed health care through the lenses of a technology entrepreneur by attending the Health Innovation Summit hosted by Rock Health in San Francisco. As a practicing primary care doctor, I was inspired to hear from Andy Grove, former CEO of Intel, listen to Thomas Goetz, executive editor of Wired magazine, and Dr. Tom Lee, founder of One Medical Group as well as ePocrates.

Not surprising, the most fascinating person, was the keynote speaker, Vinod Khosla, co-founder of Sun Microsystems as well as a partner in a couple venture capital firms.

“Health care is like witchcraft and just based on tradition.”

Entrepreneurs need to develop technology that would stop doctors from practicing like “voodoo doctors” and be more like scientists.

Health care must be more data driven and about wellness, not sick care.

Eighty percent of doctors could be replaced by machines.

Khosla assured the audience that being part of the health care system was a burden and disadvantage.  To disrupt health care, entrepreneurs do not need to be part of the system or status quo. He cited the example of CEO Jack Dorsey of Square (a wireless payment system allowing anyone to accept credit cards rather than setup a more costly corporate account with Visa / MasterCard) who reflected in a Wired magazine article that the ability to disrupt the electronic payment system which had stymied others for years was because of the 250 employees at Square, only 5 ever worked in that industry.

Khosla believed that patients would be better off getting diagnosed by a machine than by doctors. Creating such a system was a simple problem to solve. Google’s development of a driverless smart car was “two orders of magnitude more complex” than providing the right diagnosis. A good machine learning system not only would be cheaper, more accurate and objective, but also effectively replace 80 percent of doctors simply by being better than the average doctor. To do so, the level of machine expertise would need to be in the 80th percentile of doctors’ expertise.

Is it possible technology entrepreneurs can disrupt health care? He challenged any doctor in the room to counter his points.

Silence.

Was it because everyone agreed? Were the doctors in the room simply stunned? Was there a doctor in the house? And where did he get that 80 percent statistic?…

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Studying How Body Rhythms Can Help Diagnose Diseases

Studying How Body Rhythms Can Help Diagnose Diseases 

Excerpts from the 3 July 2012 Wall Street Journal article

In an effort to develop new ways of diagnosing and treating diseases, scientists are increasingly tracking the various patterns by which the body senses and reacts to stimuli.

Such patterns, commonly referred to as body rhythms, are a constant dynamic. A foot senses a crack in the sidewalk and the brain instructs the muscles to compensate so the person doesn’t fall down. Within the body, when cells detect too much carbon dioxide, the lungs respond by taking a breath. To get the right response, neurons, or nerve cells, communicate by emitting electrical impulses that are picked up by other neurons.

Researchers are finding that measuring these electrical impulses can reveal the presence of disease. Recent studies have shown that children with autism have significantly different brain-wave patterns than children without the disorder. Other studies have found that brain waves in people with epilepsy behave differently shortly before a seizure.

James Collins, a researcher at Harvard University’s Wyss Institute for Biologically Inspired Engineering, in Boston, has been investigating what he calls balance-control rhythms to understand why people are less steady on their feet as they get older and what can be done to correct that.

 

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