Sight nabs CE mark for its tabletop complete blood count reader

Sight Diagnostics received a CE mark for its point-of-care blood diagnostic device, OLO, which uses artificial intelligence to optically read small amounts of blood and provide complete blood count tests during a single doctor’s visit, and the company has begun its commercial launch in Europe and other non-U.S. markets.

After taking two drops of blood from a finger prick or venous draw, a physician can place them into a self-contained, disposable cartridge, which is then fed into the tabletop machine. Test results are then displayed on a screen within minutes.

If that sounds familiar, it is: but where Sight differs from the infamous Theranos and its cartridge-based Edison device is that OLO employs digital, multichannel microscopy—using algorithms to visually analyze different cell types by size, shape, count and morphology—while Theranos had attempted to use microfluidics and reactants to perform its blood panels.

The Tel Aviv, Israel-based Sight has already been using its core, AI-based technology to screen over 600,000 samples for malaria infections using digital fluorescent microscopy.

In addition, the company announced that it raised $25 million in equity financing, including from former Google CEO Eric Schmidt’s Innovation Endeavors fund. Sight also employs a number of computer-vision veterans from Mobileye, developers of collision avoidance technology for automated vehicles, which was acquired by Intel in 2017 for $15.3 billion.

The company’s algorithms draw from nearly half a petabyte of blood image data collected over five years of clinical work, the company said, with OLO analyzing 19 parameters to provide a full blood count and flag certain clinical abnormalities.

The move into performing complete blood count tests represents a huge expansion of the device’s potential use: CBC tests are the most prevalent blood diagnostics, and are ordered to diagnose a broad range of common conditions, including in as much as 91% of all baseline testing, Sight estimated. Typically tests are performed at a central lab, and take up to a week before receiving results.

“Having to wait a day or more for the results of basic diagnostic tests after an office visit has always been a challenge to physicians, since these results inform treatment, and physicians would prefer to place patients on the most appropriate treatment right away—during the initial visit,” said Carlo Brugnara, director of the hematology lab at Boston Children’s Hospital and a professor of pathology at Harvard Medical School. “Previous blood analyzers aimed at in-office testing have involved clinical compromises and are difficult to operate or maintain.”

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“The technology to provide full-spectrum analysis with only a finger prick of blood is seen by many as a holy grail in this space, and it’s no secret that others have tried,” said Yossi Pollak, Sight’s co-founder and CEO.

“After implementing our malaria detection technology in India and several African countries and exceeding expectations in multiple clinical trials, we were encouraged to explore our technology’s ability to enter the $35 billion market of CBC testing,” Pollak added.

Sight recently began clinical trials in the U.S. to prepare its FDA submissions, including sites at Boston Children’s Hospital and Columbia University’s Irving Medical Center. In addition, it recently completed a 287-person clinical trial at Israel’s Shaare Zedek Medical Center for its CE mark registration. The company plans to aim for an initial FDA clearance for use in qualified laboratories, before pursuing subsequent waiver applications to allow broader use at the point of care.