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

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 Tests on the Map of Biomedicine


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