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FDA clears upstart Theranos' test system

Jul. 02, 2015 4:07 PM ETAbbott Laboratories (ABT) StockQDEL, ABT, RHHBY, QGEN, TMO, CPHD, BIO, TRIB, CBMX, CEMI, AXDXBy: Douglas W. House, SA News Editor
  • The FDA issues 510(k) clearance for privately-held Theranos' diagnostic testing system and its test for herpes simplex 1 IgG, the 153rd test that the company provides for less than $10 in its service offering. The automated system the company has developed utilizes microfluidics to perform a wide array of tests on small volume blood samples, including those from a finger stick. Some observers believe Theranos will upend the clinical diagnostics industry with its modest costs. The herpes test, for example, will sell for only $9.07 compared to ~$175 from leading reference labs.
  • Theranos founder and CEO Elizabeth Holmes is one the newest celebrity entrepreneurs. Based on the company's current valuation, she is the youngest self-made female billionaire in U.S. history.
  • Some diagnostics-related tickers: (NYSE:ABT) (OTCQX:RHHBY) (NASDAQ:QDEL) (NYSE:BIO) (NASDAQ:QGEN) (NASDAQ:CPHD) (NASDAQ:CEMI) (NASDAQ:TRIB) (NASDAQ:AXDX) (NASDAQ:CBMX) (NYSE:TMO)

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