Saturday, January 28, 2017

HHS Innovation Report Executive Summary

Executive Summary 

[Highlights added]

What are the critical ingredients that drive change and fuel a culture of innovation and entrepreneurship in large, complex organizations like the U.S. Department of Health and Human Services (HHS)? 

HHS Innovation Report Jan 2017

January 15 2017

Thursday, January 19, 2017

MolDX Q&A Version 11 (November 11, 2016)

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V11  (November 11, 2016)

2016 MOLDX 1111 Q and A V 11

MolDX General Questions (M00086, V11) - + 
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Wednesday, January 18, 2017


Direct Translation Google Translate German >> English

12/2016: German Newspaper TAGESSPEIGEL

Debate over Gentest in breast cancer continues

Chemo yes or no? This decision to make due to a gene expression test is too uncertain for breast cancer patients, writes the IQWiG - and thus fires again the dispute. 


Difficult Decision. It is not always clear which breast cancer patient really needs chemotherapy. Gene expression tests should help

"Overall, the IQWiG concludes that there is currently no evidence for a benefit or harm to a biomarker-based strategy to decide whether or not to undergo adjuvant chemotherapy for primary breast cancer."


WDR DE WISSEN / Breast Cancer: After Surgery?

Direct Google Translate, German > English

Breast Cancer: After surgery, chemotherapy - or not?  December 2016
By Christina Sartori

In determining whether chemotherapy is necessary after a breast cancer operation, biomarker tests could help. The Institute for Quality and Efficiency has now analyzed their usefulness and published the results on Monday (05.12.2016).

For some women with breast cancer, the question arises after the operation: Now a chemotherapy - or rather not? In many cases, the doctor can give a clear recommendation depending on clinical factors such as age of the woman, size and shape of the tumor, and state of the lymph nodes: if these clinical factors give a certain risk that the cancer might return in a few years, then He will advise his patient to chemotherapy - otherwise not.


German Tech Assessment of Breast Cancer Molecular Prognostics

Direct Google Translation

Cited in my January 2017 blog:

[This study focuses on MINDACT because a prior broader review of the field was negative.  The question was whether MINDACT would significantly update the 2015 review.]

See responses in German press at:

Biomarker tests in breast cancer: decision about chemotherapy remains difficult

Preliminary MINDACT results make it possible to estimate the disadvantages of a therapy disability / scarcely practical advantage

The Institute for Quality and Efficiency in Health Care (IQWiG) has examined the utility that certain breast cancer patients have in biomarker tests to decide for or against adjuvant systemic chemotherapy. These are women with primary hormone receptor-positive, HER2 /neu-negative breast cancer and up to three infected lymph nodes.

When the Institute presented its preliminary report in November 2015 [one year ago], the data was not sufficient to prove the benefit or damage of such tests.

However, results of further relevant studies were announced for early 2016. At the request of the Joint Federal Committee (G-BA), the IQWiG therefore waited after the scientific discussion on the preliminary report.