It’s finally here: the Map of Biomedicine ebook!
Last year, 5AM’s Chief Science Officer Will FitzHugh started to make notes about the vast -- and expanding -- field for which we develop software: biomedicine. Originally, his purpose was keeping all of the players straight so that he and 5AM’s software development teams could have a big-picture view of the context that our clients work in, as well as details like the regulatory processes and technological shifts that impact human health.
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Tags:
biomedicine,
map of biomedicine,
diagnostic test development
The New York Times reported today that Color Genomics, a Silicon Valley startup has raised $115 million to make a $249 genetic test a reality. The test identifies faulty BRCA, as well as more than a dozen other cancer-related genes. BRCA1 and BRCA2 mutations are responsible for increasing women’s risks for developing certain breast and ovarian cancers. Filmmaker and actress Angelina Jolie has made headlines over the past few years for her decisions to undergo a preventive mastectomy, and more recently, a preventive oophorectomy in response to her own gene-related disease risks.
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Tags:
cancer,
biomedicine,
23andMe,
diagnostic test development,
diagnostics,
BRCA
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
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
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
