Health and Medical News and Resources

General interest items edited by Janice Flahiff

[News release] Intestinal gas could be used to diagnose diseases

Intestinal gas could be used to diagnose diseases

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From the 12 March 2015 news release at Medical Xpress

Microbes in the human body are estimated to outnumber human cells by 10 to 1, yet research on how they affect health is still in its infancy. A perspective article published by Cell Press on March 12th in Trends in Biotechnology presents evidence that gut microbes produce gases that may contribute to gastrointestinal diseases and could be used as biomarkers for one’s state of health. As means to measure these potential biomarkers, the authors suggest two novel gas-sensing systems, one of which is an electronic gas sensor in the form of a pill you can swallow. These systems may offer a reliable and economical way to understand the impact of intestinal gases on human health, paving the way for the development of new diagnostic techniques and therapies.

March 16, 2015 Posted by | Medical and Health Research News | , , , , | Leave a comment

[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.

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 20, 2015 Posted by | Consumer Health | , , , , , , , , | Leave a comment

[Press release]Paper electronics could make health care more accessible

aPaper electronics could make health care more accessible.

From the 19 November 2014 EurekAlert

Flexible electronic sensors based on paper — an inexpensive material — have the potential to some day cut the price of a wide range of medical tools, from helpful robots to diagnostic tests. Scientists have now developed a fast, low-cost way of making these sensors by directly printing conductive ink on paper. They published their advance in the journal ACS Applied Materials & Interfaces.

Anming Hu and colleagues point out that because paper is available worldwide at low cost, it makes an excellent surface for lightweight, foldable electronics that could be made and used nearly anywhere. Scientists have already fabricated paper-based point-of-care diagnostic tests and portable DNA detectors. But these require complicated and expensive manufacturing techniques. Silver nanowire ink, which is highly conductive and stable, offers a more practical solution. Hu’s team wanted to develop a way to print it directly on paper to make a sensor that could respond to touch or specific molecules, such as glucose.

The researchers developed a system for printing a pattern of silver ink on paper within a few minutes and then hardening it with the light of a camera flash. The resulting device responded to touch even when curved, folded and unfolded 15 times, and rolled and unrolled 5,000 times. The team concluded their durable, lightweight sensor could serve as the basis for many useful applications.

November 25, 2014 Posted by | health care, Uncategorized | , , | Leave a comment

   

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