Serum nucleic acid sampling to screen for malignancies has a few problems. One issue is that it runs into the realities of Bayes theorem.<p>You may want to consider what happened to Pathway Genomics.
Their screening test claiming to detect 10 cancers in healthy people drew the ire of the U.S. Food and Drug Administration past year, which sent the company a letter saying:<p>&quot;We have [...] examined published literature and have not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high risk individuals,&quot; the letter states.<p>... We have reviewed the information presented on your website in the white
paper, entitled “Liquid Biopsy for the Detection and Monitoring of Cancer: Analysis of 96
Hotspot Mutations via Plasma Derived Circulating Tumor DNA,” dated September 2015. It is
unclear how the literature that you cited, addressing the presence of circulating tumor DNA
(ctDNA) in already-diagnosed patients, is adequate to support the expansive claims of screening
for early cancer detection using ctDNA in undiagnosed patients for up to 10 different cancers
with the CancerInterceptTM Detect...<p>We believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health..&quot;<p>For the full letter from the FDA, see <a href="http:&#x2F;&#x2F;www.fda.gov&#x2F;downloads&#x2F;MedicalDevices&#x2F;ResourcesforYou&#x2F;Industry&#x2F;UCM464092.pdf" rel="nofollow">http:&#x2F;&#x2F;www.fda.gov&#x2F;downloads&#x2F;MedicalDevices&#x2F;ResourcesforYou&#x2F;...</a> ( it is a pdf )