Wednesday, February 26, 2014

Oh, patents! Theranos micro-sample lab testing

Copyright © Françoise Herrmann
For those with needle phobia Theranos might save you, or your small children, from a lot of stress and anxiety!

Theranos, a Silicon Valley biotech company, has changed the face of lab testing allowing for multiple lab tests to be performed with a single tiny drop of blood instead of multiple vials. And what is more, this testing can be performed at Walgreen’s, where a proprietary infrastructure for analyzing samples -- at point-of-service without a skilled operator -- both minimizes the main source of errors and ensures the results of your tests are provided in about 4 hours! 

All that is needed for multiple tests is a micro-sample obtained via finger stick, as small as 1/1000 the size of a typical blood draw. You can say goodbye to “big bad needles” for good!

And perhaps best of all, the Theranos CLIA-certified laboratory testing is performed at a fraction of the costs of traditional testing. The costs of tests are even posted at the Theranos website ( 

For example, consider a lipid panel at the Theranos cost of $9.21 compared to the traditional LabCorp lipid panel price of $100.00.  In fact, the company even expects to save Medicare and Medicaid more than respectively 90 and 60 billion dollars in the next 10 years! It is already billing at 50% under threshold reimbursement levels, and fully believes this low cost access is part of a human rights perspective on health care and health. [Wired Data Life Interview with CEO Elizabeth Holmes, Nov. 27, 2013]


All of the Theranos biotechnology is patented, from sampling to analyses methods and point of service processes. An EPO search for Theranos returns 127 patents! 

The WIPO patent WO2014015191 titled Low-volume coagulation assay is one of these patents. This patent recites compositions and methods for measurement of blood coagulation factors with a very small amount of blood, about 20 µl, compared to the traditional amount of 5 ml collected in a fixed volume vacuum vial, and which also leaves plenty of the drop of blood collected for other Theranos tests! 

The measurement of blood coagulation is important since inadequate coagulation can lead to increased risk of bleeding (hemorrhage), whereas excessive coagulation can lead to obstructive clotting (thrombosis).  Although blood coagulation testing has existed for many years, this low volume assay invention simplifies getting tested, obtaining results, reduces errors and ultimately makes testing accessible to far more people both due to lowered costs and to the simplicity of the neighborhood process.   

Below appears the abstract for WO2014015191 titled  Low volume coagulation assay and images appear above of the 1.29 cm Nanotainer™ vial (smaller than a dime) containing a drop of blood for all the Theranos analyses that your doctor orders!

Compositions and methods for measuring coagulation parameters using very small volumes of blood are provided. Advantageously, the methods described herein can be performed from a single drop of blood (about 20 Ill) while generally leaving enough sample to perform other measurements, optionally in a multiplexed format. The methods and devices do not require a skilled operator and can be performed at the point of service, which can be an important feature for managing blood coagulation disorders and treatments thereof. [Abstract WO2014015191]


Oh, and you must hear Elizabeth Holmes, CEO of Theranos, and Stanford student who dropped out of her sophomore year to build Theranos, speak about how to make it work in the YouTube video below !

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