Natera (NASDAQ:NTRA) announces the termination of a distribution agreement with Bioreference Laboratories. With the ending of the distribution agreement, Natera intends to promote prenatal screening test Panorama directly to clinicians, who previously ordered this test through Bio-Reference (NASDAQ:BRLI).
Natera also plans to promote its Horizon carrier screen test to clinicians, which it had not done previously.
The FDA grants a Clinical Laboratory Improvement Amendments (CLIA) Waiver to privately-held Theranos for its diagnostic test system. The waiver allows the testing to be performed in non-traditional locations such as Theranos Wellness Centers, currently 42 in Arizona, one in Palo Alto, CA and one in Harrisburg, PA.
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 company's 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.