Israeli fingerprick blood testing company gets FDA clearance for CBC analyzer

With the regulatory nod, Sight Diagnostics can have its computer-vision powered blood analyzer be sold to hospital labs to provide lab-grade results within 10 minutes on just two drops of blood.

The opportunity presented in fingerprick blood testing is one that many companies are chasing.

Among these is Israeli diagnostics firm Sight Diagnostics, which announced that the Food and Drug Administration has cleared its Olo blood analyzer to perform a complete blood count(CBC) test on just two drops of blood. The complete blood count test –which calculates and characterizes the number of red blood cells, white blood cells, and platelets in a patient’s blood sample – is one of the most routine tests prescribed.

The clearance allows for fingerprick testing and the more traditional venous blood draws to enable complex testing using the Olo analyzer that can now be used in laboratories run by hospitals. The regulatory action was based on data from clinical trials run on the device that showed lab-grade results at Boston Children’s Hospital, Columbia University Medical Centre and Tricore Labs.

While in the U.S., the clearance is only for hospital lab use, in Europe the technology can be used more broadly. Sight Diagnostics has initiated a pilot program with a major U.K. health and beauty retailer — Superdrug — to bring blood testing to its health clinics.

In a phone interview from Israel, Sarah Levy, chief technology officer of Sight Diagnostics, said that the company has already received orders from U.S. hospitals but she declined to name them. Nicklaus Children Hospital in Miami is testing the device.

The Olo analyzer from Sight Diagnostics

Olo represents a major innovation in our laboratories’ CBC analysis: introducing finger-prick and venous sampling, five-part differential and flagging. It’s a truly welcome development,” said Dr. Steven Melnick, chief of pathology at Miami’s in a news release announcing the clearance. “At current volumes, we believe OLO will substantially reduce our costs.”

The Olo prep kit

The CBC test is the second test being on the Olo platform — the first was a malaria test for developing nations in Asia and Africa. Till date, Sight Diagnostics has sold nearly a million malaria of this test, Levy said.

So how does the platform work? Sight Diagnostics takes images of blood samples, thereby “digitizing blood” and then uses computer vision and deep learning algorithms the company has developed over 10 years to “analyzes those images as fast as they are being captured to identify the different components, to measure them to classify them and so on,” Levy explained.

Results are delivered on two drops of blood within 10 minutes.

Computer vision — hence the name Sight Diagnostics — is what is truly important and that is one reason the company’s press release announcing the FDA clearance steers clear of any mention of artificial intelligence.

The actual thing is convolutional [neural] network, machine learning, computer vision — these are accurate terms to describe what we are doing and AI is much more general and high-level, so it sounds more like a buzzword,” Levy said.


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