We all know the story of Elizabeth Holmes and the demise of Theranos, a company that claimed to have created a device that could provide fast and efficient blood tests. Theranos ended being a company based on hubris, imagination, and vapor. It eventually collapsed being charged with massive fraud.
Today, leading crowdfunding platform OurCrowd is sharing the news that their portfolio company Sight Diagnostics is succeeding where Theranos failed.
According to OurCrowd, Sight Diagnostics’ patented OLO blood analyzer that can perform most common blood test in minutes, has received clearance from the U.S. Food and Drug Administration.
The clearance of its OLO analyzer is for a “ubiquitous and essential blood test, the “Complete Blood Count” (or CBC). OLO provides lab-grade CBC results in minutes.”
The FDA clearance follows clinical trials performed at Boston Children’s Hospital, Columbia University Medical Centre and Tricore Labs.
The complete blood count, a test that enumerates and characterizes the number of red blood cells, white blood cells, and platelets in a patient’s blood sample, is said to be is one of the most informative tests a doctor can conduct.
Dr. Carlo Brugnara, Director of the Hematology Lab at Boston’s Children’s Hospital and Professor of Pathology at Harvard Medical School, explains that the CBC is an important data point for determining whether an illness is viral or bacterial.
OLO’s FDA approval is said to confirm its lab-grade performance while operating from just two drops of blood.
The OLO analyzer is already commercially available in Europe and other international markets – now it will enter the US market.
Sight Diagnostics has received six U.S. patents with more pending.
In the future, Sight intends to pursue a CLIA waiver from the FDA to certify OLO for use in smaller practices and pharmacies in the United States.
The FDA approval foreshadows future blood tests that may be able to be performed quicker and at a lower cost as Medtech gains traction.
Sarah Levy, Sight’s CTO, says:
“Our end-goal is to offer diagnostics for any disease with visible signatures in the bloodstream. We are confident Sight can continue to improve patient outcomes through new, faster, less costly, and more convenient testing.”
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