/An Early Mark Blog/

February 2019

Theranos, the FDA, and the Laboratory-Developed Test (LDT) loophole

By |2019-02-13T12:00:30+00:00February 13th, 2019|

Cover of Forbes 400 Sept 2015 issue: "The Freshman: Elizabeth Holmes leads the class of 2014" Theranos, the FDA, and the Laboratory-Developed Test (LDT) loophole How could Theranos get away with fraud for such a long time? The American television news broadcaster ABC has produced an excellent six-part audio podcast called “The Dropout” [...]

Raising colorectal cancer screening rates is a tough task

By |2019-02-11T18:29:32+00:00February 11th, 2019|

Raising colorectal cancer screening rates is a tough task An accurate blood-based test to detect colorectal cancer is the key to lowering the mortality from this devastating disease Screenshot from USPSTF CRC screening video     In 2018 there were an estimated 140,250 new cases of colorectal cancer (CRC), and 50,630 estimated deaths, [...]

Why is stool such a difficult non-invasive starting material for early colorectal cancer detection?

By |2019-02-06T10:10:38+00:00February 6th, 2019|

Why is stool such a difficult non-invasive starting material for early colorectal cancer detection? Fecal Immunohistochemistry Tests (FIT) and guiac-based Fecal Occult Blood tests (gFOBT) are inexpensive and widely available tests for colorectal cancer screening. However there remains a clear need for an accurate blood-based colorectal screening test. A stool collection vial for colorectal [...]

The difference between plasma and serum for cell-free DNA liquid biopsies

By |2019-02-04T15:48:12+00:00February 4th, 2019|

Blood collection tubes prior to centrifuging The difference between plasma and serum for cell-free DNA liquid biopsies Important pre-analytical sampling considerations for DNA and protein biomarker work Using plasma or serum for analysis of novel biomarkers for the early detection of cancer is an effort that spans decades. Thanks to its minimally-invasive nature, [...]

January 2019

The power of methylation haplotypes

By |2019-01-31T14:24:19+00:00January 31st, 2019|

The power of methylation haplotypes How NGS technology informed biology and now transforming cancer diagnostics with an epigenomics Cambrian Explosion Finding a cell-free cancer signal is like finding a needle in a haystack... Of the 28 million CpG residues in the human genome, 60% to 80% of them are methylated at the 5’ [...]

Five Phases of Biomarker Development for Early Detection of Cancer

By |2019-01-28T06:37:54+00:00January 28th, 2019|

Five Phases of Biomarker Development for Early Detection of Cancer Where are the retrospective studies? Collecting samples About two decades ago was an exciting time in biology, and optimism reached a peak with the first draft of the Human Genome Project announced in 2000 (“A revolution in preventing, diagnosing, treating, and curing disease” [...]

December 2018

Optimum plasma sample collection and handling for cell-free DNA liquid biopsies

By |2019-01-28T06:02:21+00:00December 13th, 2018|

Optimum plasma sample collection and handling for cell-free DNA liquid biopsies A recent publication indicates the best way to preserve intact cell-free DNA for any minimally-invasive genomic assay Liquid biopsy, whether examining cell-free DNA or circulating tumor cells (CTCs), is a very promising approach for non-invasive cancer management. In particular, cell-free DNA approaches in plasma [...]

Singlera ASHG Presentation now available

By |2019-01-28T14:04:53+00:00December 5th, 2018|

Screen capture from Dr. Gore's video presentation of the Singlera early-detection technology. Singlera ASHG Presentation now available A video presentation by Dr. Athurva Gore, Assoc. Director of Bioinformatics Singlera Genomics, is now available. The title of his talk is "Circulating tumor DNA methylation haplotypes in plasma can detect cancer four years prior to [...]

November 2018

The four fundamentals of early warning systems

By |2019-01-28T14:06:38+00:00November 26th, 2018|

Hurricane Katrina as seen from space The four fundamentals of early warning systems A way to look at early cancer detection A hurricane afflicts damage across Florida. Wildfires rage through California. A deadly typhoon afflicts central Japan after weeks of flooding. These natural disasters occur with disturbing regularity. An individual's health can also [...]

Current screening approaches for early cancer detection

By |2019-01-28T14:19:26+00:00November 20th, 2018|

Mammography, a common cancer screening test Current screening approaches for early cancer detection The American Cancer Society screening recommendations and a thought experiment A recent article by a Stanford professor (and Andreessen Horowitz venture fund general partner) Vijay Pande in The Scientific American, entitled "How to Engineer Biology", subtitled 'Billion-dollar bridges rarely fail—whereas [...]

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