The origin of the FDA and the Elixir Sulfanilamide disaster of 1937 Safe and effective means just that to the Food and Drug Administration A bottle of the Elixir of Sulfanilamide The Pure Food and Drug Act of 1906 The early 1990’s was the age of the Progressive Era, and one key piece [...]
For colorectal cancer, the only good screening test is one that is taken Tests for detecting hidden (“occult”) blood in stool is widely available Screenshot from USPSTF CRC screening video We have discussed before the challenge of raising colorectal cancer screening rates, and the fact that there are many options in addition to [...]
The high standard of reimbursed diagnostic tests The difference between the standards of the FDA and CMS Figure from NAMSA CMS Reimbursement Webinar For a diagnostic test to get the imprimatur of FDA approval, the manufacturer has to cross a number of hurdles. Last week, the IVD consultancy NAMSA gave a web presentation [...]
Calculating the odds of undetected colorectal cancer In a group of 200 adults aged 50 to 75, what are the chances of finding someone with undetected CRC? Many take chances with their health, in particular CRC screening The unscreened population for colorectal cancer is large. According to Exact Sciences (the manufacturer of the [...]
DNA Methylation Biomarkers for Cancer – a Measurement Challenge Although studied for decades, the study of methylated cytosine DNA residues is not a trivial task for clinical in vitro diagnostics The challenge of methylation analysis in clinical diagnostics In the world of diagnostics, the measurement of biological analytes for clinical use trace its [...]
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 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? 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 [...]
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, [...]
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’ [...]
