Up at 5AM: The 5AM Solutions Blog

Direct-to-Consumer Diagnostics vs. Regulatory Mechanisms

Posted on Tue, Dec 02, 2014 @ 04:15 PM

Today, I’m going to broaden the topic of diagnostics to talk about the most important person in this discussion - you! 

I’ve been focusing on diagnostic tests that your doctor orders for you. But there are some tests that you can buy yourself. For instance, you can go to a drugstore right now and buy a pregnancy test, a diabetes blood sugar test, or even a home drug test. These are often called direct-to-consumer tests. For a test to be direct-to-consumer, it has to be easy to take and the results have to be easy to understand.

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Tags: map of biomedicine, diagnostics, LDT

Psychology of Diagnostics Not Always Aligned With Best Care Decisions

Posted on Thu, Nov 06, 2014 @ 03:00 PM

In my last post I talked about accessing your health information, including the results of diagnostic tests. In general I think people should be more aware of what their test results mean, and how their physicians use those results to make decisions about treatments and other tests.

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Tags: map of biomedicine, diagnostics

MoB: Your Health Data Belongs to You

Posted on Thu, Oct 23, 2014 @ 03:00 PM

Lab results must be returned to patients who request them

These Map of Biomedicine blog posts have been focused on how diagnostic tests get to market, from an interesting biological discovery to a test that your doctor can order to help guide your treatment or diagnose disease. We saw that there were different ways this could happen, with or without the involvement of the Food and Drug Administration.

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Tags: map of biomedicine, electronic health record, electronic medical records, health data

The Business of Developing Tests for Diagnostics

Posted on Thu, Oct 02, 2014 @ 03:00 PM

As we’ve seen in previous posts, the world of diagnostic test development is quite complicated. In addition to the multiple ways a diagnostic test can get to market, there are many different types of organizations that develop and run tests. Take a look at this zoomed-in view of the Map of Biomedicine:

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Tags: personalized medicine, map of biomedicine, diagnostics

Ebola Vaccine in Clinical Trials

Posted on Tue, Sep 09, 2014 @ 03:30 PM

Twenty human subjects became participants in clinical trials for an Ebola vaccine. Almost 2300 people have died from the disease since January 2014 when an outbreak of the disease began and spread through western Africa. In an animal study, four crab eating macaques showed immunity to lethal doses of the virus when they were inoculated with a vaccine.

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Tags: clinical trials, map of biomedicine, ebola

Next Gen Diagnostics

Posted on Tue, Sep 02, 2014 @ 03:00 PM

The Sixth Annual Next Generation Dx Summit (NGDx) was the first conference I have attended in quite a few years. I was drawn to it by its emphasis on new research areas in clinical assay development and how the biomedical industry can bring these potentially life-saving diagnostics to market to fight diseases and benefit personalized medicine (PM). I decided to focus on two tracks for the conference. Companion Diagnostics: Strategy & Partnerships appealed to my personalized medicine interests and Clinical Application of Cell-Free DNA allowed me to see new research on a specific application of a potentially game-changing diagnostic approach.

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Tags: cancer, map of biomedicine, diagnostics

Traditional Diagnostics vs. Genomic Testing

Posted on Thu, Aug 28, 2014 @ 03:00 PM

In my last Map of Biomedicine blog post, I discussed companion diagnostics and the FDA approval process for such tests. In this post, I’ll be talking a little bit about research use only (RUO) tests and use that to segue into a discussion about a kind of test that is going to turn diagnostic testing on its head.

The distinction between RUO tests and the clinical tests we’ve been discussing is pretty simple. RUO tests are used only in research studies with consenting participants. The big catch is that the results of the tests won’t be used to change the patient’s treatment. On top of that, the results are often anonymized so that the researcher doesn’t even know who the participants are.

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Tags: map of biomedicine

Map of Biomedicine: Premarket Approval for Diagnostic Products

Posted on Thu, Jul 31, 2014 @ 12:00 PM

In the last few Map of Biomedicine blog posts I’ve talked about several different ways that diagnostic products can get to market. Laboratory-developed Tests (LDTs) and tests that get 510(k) approval (for tests that are similar to existing tests) are two ways.

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Tags: map of biomedicine, diagnostic test development, 510(K), LDT, PMA, Premarket Approval

Map of Biomedicine: Getting Diagnostic Products to Market

Posted on Thu, Jul 10, 2014 @ 12:00 PM

In my last post, I talked about the laboratory-developed tests (LDT), or “home brews.” LDTs are run in individual labs whose operations are regulated under Clinical Laboratory Improvement Amendments (CLIA). The home brews, however, are essentially unregulated, except in the sense that physicians and hospitals won’t recommend tests that aren’t good for their patients.

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Tags: map of biomedicine, diagnostic test development, 510(K), LDT, PMA

Diagnostic Test Development on the Map of Biomedicine

Posted on Thu, Jun 26, 2014 @ 06:39 PM

As I said in my introductory post to this series on the Map of Biomedicine, there’s incredible value in being to able to understand how things operate at a high level and also be able to drill down and see details. At the end of that post I showed a picture of the Map of Biomedicine that I’ve been working on. We’ll get back to talking about the overall map later, but for now I want to talk about some parts of the map in more detail. And just to answer one question up front: I’m sure this map will change. I’m guessing that in the process of writing these blog posts and fielding questions and comments, I’ll identify gaps and adjustments that will make the map more complete.

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Tags: map of biomedicine, diagnostic test development, diagnostics, BRCA

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