GET OUR BLOG IN YOUR INBOX

Your email:

Follow Us

FREE Biobanking Ebook

Biobanking Free Ebook
Get this 29 page PDF document on how data science can be used to advance biorepositories.

Free NGS Whitepaper

NGS White Paper for Molecular Diagnostics

Learn about the applications, opportunities and challenges in this updated free white paper. 

Up at 5AM: The 5AM Solutions Blog

Current Articles | RSS Feed RSS Feed

Map of Biomedicine: Premarket Approval for Diagnostic Products

  
  
  
  
MoB Information Architecture Companion Dx Hilite

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.

Skin Cancer - Tales from Two Hemispheres

  
  
  
  
sidtheseagull

Experts around the globe agree that most skin cancers are preventable. They disagree, however, on what skin cancer prevention looks like.

Long Commute? Update Your Software.

  
  
  
  
5AMers think about software a lot.

5AMers think about software. A lot.

Practicing Our Craft - Developing Great Software

  
  
  
  
craftsmanship s

The clock shows a minute past noon. The stragglers of a steady stream of 5AMers finish sneaking in the conference room door and quickly take their seats. Someone dims the lights while another finishes pulling the shades. A hush comes over the room. “Everybody ready?” Nods answer. A mouse cursor clicks the play button. The frozen bespectacled figure on the projector screen comes to life. In a stern voice, he declares, “Integrated tests are a scam – a self-replicating virus that invades your projects! It threatens to destroy your codebase, to destroy your sanity, to destroy your life.” Another 5AM Tech Talk begins…

FDA: "Get More Men in Breast Cancer Trials"

  
  
  
  
HIS

This year, 2000 men in the U.S. will be diagnosed with breast cancer. Fewer than 500 of them will die from the disease. In general, men's chances of developing the disease are about 100 time less that of women's. Comparatively, about 200,000 women will receive a breast cancer diagnosis.

EMR Data + Clinical Trials = 21st Century Cures

  
  
  
  
Researcher

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a hearing entitled "21st Century Cures: Modernizing Clinical Trials" last week.

Map of Biomedicine: Getting Diagnostic Products to Market

  
  
  
  
MoB DXTESTINGMarket

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.

Taking Pharma to Where the Patients Are

  
  
  
  
twitter 512

According to Murray Aitken, Executive Director of the IMS Institute for Healthcare Informatics “Social media is where the patients are.” 

Sky Lab: Is the Future of Life Sciences Research in the Cloud?

  
  
  
  
National Physical Laboratory  Science and Technology in Wartime, Teddington, Middlesex, England, UK, 1944 D23194

The Wall Street Journal reported on an in interesting development in life sciences research. Silicon Valley has begun sprouting cloud-based laboratories that could lower one of the highest barriers to entry for researchers: the cost of setting up a lab.

Open to the Public: Making Health Data Mainstream

  
  
  
  
simple.b dis jpg.ha7893bb390265f06e0cf2b2789e466c7

It isn’t exactly a problem; but it is a thing. 

All Posts