Elizabeth Holmes was a dynamic, visionary and committed scientific entrepreneur—but there was just one problem—she didn’t have the science to back her claims and ultimately succumbed to the darker side of human nature, exhibiting bad morals in an orchestrated cover-up to protect her lofty valuation. You see, all of the money, prominent people, and big talk can’t take you to the research, development and commercialization promised land. That takes real intellect and thoroughly vetted science as well as openness to scientific scrutiny. Enter Israel’s Sight Diagnostics.
Founded in 2011 by a Hebrew University alum Yossi Pollak, previously at Intel subsidiary Mobileye, and Daniel Levner, former scientist at Harvard’s Wyss Institute for Biologically Inspired Learning, the Sight Diagnostics team first developed a niche blood test apparatus for malaria. Apparently, the Tel Aviv-born technology could perform a test to determine if an individual had malaria within minutes.
Now the Tel Aviv team has released the OLO analyzer—a device about the size of a toaster, reports From the Grapevine, that requires a couple blood drops from a finger prick. Within 10 minutes thereafter the device’s output: a Complete Blood Count—known as CBC in the profession. This test can generate the number of red blood cells, white blood cells and platelets in patient blood samples.
A compelling advancement, it represents a breakthrough for physician-ordered tests and a play for a $2.7 billion leader Sysmex. For example, Dr. Carlo Brugnara, Director of the Hematology Lab at Boston Children’s Hospital and Professor of Pathology at Harvard Medical School starts, “The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial.” He continued that “in rarer cases—involving acute leukemia, for instance—a CBC can make the difference between life and death.”
Brains, Phased Approach & Humility
Silicon Valley is a place of big dreams and big bets. The right outcomes can lead to home-run returns. That was the world of Ms. Holmes at Theranos. On the other hand, Israel is a small country and although known as a startup nation with a lot of very smart, hard-working people, many of its’ ventures can’t help but take things in smaller steps. This surely is the case for the Sight Diagnostics’ crew: start small and work the way up the value chain. For example, while Sight focuses on a subset of hematology—intense intellectual focus on solving the scientific problems at hand on a subset of hematology at this stage—Ms. Holmes didn’t hold back selling the big vision as ready to rule the world: a test that could execute hundreds of tests across the four main classes of blood tests including hematology, immunoassays, general chemistry and DNA amplication. High profile figures in government, military and investor circles bought in hook line and sinker—duped by marketing-driven, “Steve Jobsesq” grand vision and some hubris.
Already available commercially in Europe and other international markets, this week the Israel-based venture publicly disclosed their device had been cleared by the U.S. Food and Drug Administration (FDA). The clearance followed clinical trials that occurred at Boston Children’s Hospital and Columbia University Medical Center.
A key study commenced June, 2018 where the sponsor and clinical research site lead, Columbia University, conducted clinical and analytics tests to assess the risk and verify the performance of the investigational device in accordance with its specifications.
Now armed with FDA clearance, the small, incrementally focused venture can now do much bigger things than Ms. Holmes could only dream about—legally market and sell a potential game changing technology in the blood test market. If the product works as promised, laboratory costs can be cut with lower blood volumes. For example, the conventional CBC tests depend on flow cytometry technology, hence requiring costly personnel maintenance while the standard procedure takes at least a day to process. Now OLO analyzer, based on sophisticated algorithms, digitizes such samples into images and compresses the time for blood sample analysis. Sight Diagnostics has bigger targets in sight now—such as Quest Laboratory and Laboratory Corp of America Holdings—multi-billion dollar players in the testing and diagnostics market.
Sight Diagnostics raised at least $52.8 million according to CrunchBase. Key investors include Go Capital, Jack Nicklaus (angel), Longliv Ventures, Steven Esrick (angel) and ForMED Ventures.
Jane Netterwald, Columbia University
Eldad Hod, MD, Columbia University
Call to Action: For more information see the company’s contact information.