The promising story of Theranos, the Palo Alto, California-based health-diagnostics company that managed to raise a total of US$686.3 million in investment pushing its value to $9 billion, took an unfortunate turn in 2016. What had been a media love-affair with Theranos and its founder/CEO Elizabeth Holmes, celebrating the company's much-hyped technology that claimed to allow 30 diagnostic tests to be run on a single drop blood from a finger-prick, soured considerably when the bold claims could not be substantiated. Not only were they not backed up with proof that their technology worked, it started to appear that they were in violation of a number of federal regulations in place to protect the public's well-being. When federal regulators barred Holmes from owning or operating a medical laboratory for at least two years, the future of Theranos was thrown into chaos. Silicon Valley investment banker Robert Colman filed a lawsuit against Theranos, alleging fraud. He accuses Holmes and Theranos president Ramesh Balwani of soliciting investment "built on false statements and omissions."
How so much money managed to find its way to Theranos, when in the latest analysis, they have never proven the technology at the core of their business model, is for many in the venture capital game, puzzling. One thing is certain -- The first company to successfully bring to market a product that allows a battery of blood-diagnostics to be run on a single drop of blood, will make a lot of money. How much? Probably many billions of dollars. Perhaps investors were so intoxicated by the potential upside of investing in a company with such disruptive technology, they simply forgot the customary due-diligence.
Theranos, however, is not the only participant in this billion dollar "Blood Rush" -- On November 21, 2016 another company in the blood-testing space, Genalyte announced a funding round of $36 million. “We are pleased to see continued commitment from the investor community for cutting edge technologies in the diagnostics sector,” said Genalyte founder and CEO Cary Gunn. “Genalyte will be using these funds to fully develop our platform, and to prove performance through additional clinical studies.”
Another horse in this race, is DMI (DNA Medicine Institute) in Cambridge, Massachussets. In 2014, its CEO and Head Scientist Eugene Chan led a team to win Nokia's prestigious xPrize, the $2.25 million global competition to accelerate the development of sensors and sensing technology that is smaller, lighter and able to capture true clinical data on a personalized scale.
As of this writing, the quest to develop accurate diagnostics for a single drop of blood derived from a finger-prick remains elusive.
HUMAGNA asked Dr. Julia Gleize MD, who has done research in blood-diagnostics, whether or not it's even feasible to produce a blood sample with a finger-prick that will allow accurate diagnostics.
Dr. Gleize explains, "The primary issue would be contamination from the finger-prick, which is essentially a puncture wound. You would expect to find both interstitial fluid and damaged tissue in such a sample. With a sample size of a single drop of blood, which by modern definition is fifty microliters, the contamination ratio may be too high to yield a diagnosable sample.