Amid FDA Concerns, Theranos Revolutionizing US In-Vitro Diagnostics Market

Published By : 23 Dec 2015 | Published By : QYRESEARCH

In-vitro diagnostics are being extensively used for health screening and medical diagnosis as well as for genomics, genetic testing, food testing, veterinary diagnostics, research, and environmental testing. While application segments such as blood glucose monitoring and clinical chemistry are relatively mature, the growing of personalized medical treatment has led to the rapid development of molecular diagnostics. Increasing diabetic population across the globe, accelerating sales of medical technological devices, and development of cardiac troponin assays have boosted the growth of the global in-vitro diagnostics market.

In the U.S. in-vitro diagnostics market, Theranos is disrupting the competitive landscape. The U.S. in-vitro diagnostics market is monopolized by LabCorp and Quest Diagnostics. Together, these nationwide testing groups account for 46% share in the non-hospital independent laboratory market which generates revenues worth US$25 bn annually. The rest of the market is flooded with small independent labs. Theranos, a Silicon Valley business founded in 2003 by Elizabeth Holmes, is trying to revolutionize the market with reduced prices of tests as well as time duration to receive test results. Further, the company is letting patients to bypass their doctors and order their own diagnostics from a menu of over 260 tests available at Theranos outlets. Theranos has its own proprietary diagnostic test devices- a finger-prick vial called nanotainer, and a laboratory machine to give accurate results for the blood samples collected through nanotainer. The government of Arizona has recently passed a law to allow such kind of direct-to-consumer testing.

However, the company has lately received flak from the FDA regarding the usage of its devices to collect blood without the adequate approvals. Though the company has stated that all the FDA concerns have been addressed, industry analysts and investors feel that the company should adjust its strategy and move to simpler ‘point of care’ testing.

Back To Top