ASCP Comments on Theranos’s Decision to Throw Out Two Years’ Worth of Diagnostics

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Inaccuracies in testing can lead to misdiagnosis or ineffective treatment in patient care

Quality clinical laboratory testing is the key to improving healthcare outcomes. That message is underscored by a recent decision by Theranos, the $9 billion company known for its fingerprick blood draw for dozens of tests, to throw out two years’ worth of diagnostic testing done with its highly-touted technology (http://www.bloomberg.com/news/articles/2016-05-19/theranos-corrects-tens-of-thousands-of-blood-testing-results). The company has voided all of its 2014 and 2015 test results from its Edison blood-testing devices, which was said to be capable of running multiple tests on a few drops of blood. Theranos marketed the test directly to consumers at a fraction of the cost of tests conducted in laboratories.

“This clearly demonstrates the value of quality laboratory testing,” said ASCP Chief Executive Officer E. Blair Holladay, PhD, SCT(ASCP)CM. “For patients, accurate test results matter in order to get the right diagnosis and the right treatment. If it were my life on the line, I’d want a test that was performed in a clinical laboratory by a pathologist or certified medical laboratory professional.”

Inaccuracies in testing can lead to misdiagnosis and ineffective treatment, said Jack Hager, MS, MT(ASCP)SBB, former CEO of the American Red Cross National Testing Laboratory, in Portland, Ore., and a past Chair of the ASCP Council on Laboratory Professionals. The greater the inaccuracy, the more likely a misdiagnosis or ineffective treatment, he added. Additionally, false negative results will mean the results indicate the patient doesn’t have a problem, when they actually do. If the condition affects the patient’s health, they may find out later the test was falsely negative. False positive results communicate to the patient and their healthcare providers that they have a condition when, in actuality, they do not. This can cause anxiety and unnecessarily treatment or further testing. The false positive can be avoided if more specific testing methods are used.

“Any process adjustment that a manufacturer implements that does not maintain the quality associated with the license of the original product puts the accuracy of the testing and by extension, patients at risk,” said Hager. “Changes that affect quality are counterproductive in providing therapeutic and diagnostic testing services to patients.”

Laboratory tests drive most medical decisions, which underscore the important role that medical laboratory professionals play in the delivery of health care. Laboratory tests are medical procedures that involve testing samples of blood, urine, or other tissues or substances in the body. Doctors use laboratory tests to help identify changes in a patient’s health condition before any symptoms occur, diagnose and plan treatment for a disease or condition, evaluate a patient’s response to treatment and monitor the course of a disease over time.

For reasons of patient safety and quality laboratory testing, the American Society for Clinical Pathology (ASCP) supports personnel standards for laboratory professionals. These standards could take the form of practice requirements, certification requirements, or licensure.

Hager said, “There is great value in following the process of test development with transparency to all stakeholders: scientists, clinicians, consumers, and investors. The scientific and medical profession’s scrutiny of diagnostic testing is a long and thorough process, as it should be if we are to ensure patient outcomes.”

About ASCP
Founded in 1922 in Chicago, ASCP is a medical professional society with more than 100,000 member board-certified anatomic and clinical pathologists, pathology residents and fellows, laboratory professionals, and students. ASCP provides excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals. To learn more, visit http://www.ascp.org. Follow us on Twitter at http://www.twitter.com/ascp_chicago and connect with us on Facebook at http://www.facebook.com/ASCP.Chicago.

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Susan Montgomery
American Society for Clinical Pathology
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