Mar 9, 2016 | Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
High rates of variability from one drop to another raise questions about the reliability of point of care testing equipment and companies that collect lab specimens only with finger sticks
Since last fall, one news report after another has come out with bad news for Theranos Inc., the high-profile medical laboratory company. The reports have ranged from dissatisfaction among Theranos’ partners, such as Walgreens and Capital BlueCross, to failed inspection reports from the federal Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA).
In response, the embattled lab company in Palo Alto, Calif., has maintained that it is doing everything it can to correct any deficiencies in its clinical laboratory testing methods and to ensure its partners that its processes are scientifically sound and its methods valid. (more…)
Sep 21, 2015 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Pathology, Laboratory Testing
This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology
Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.
One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.
The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility. (more…)
