Israeli startup Sight Diagnostics has received US Food and Drug Administration clearance to market a blood test device that can extract the results of a standard complete blood count test from just a drop of blood in minutes.
The FDA approval was given following clinical trials held at Boston Children’s Hospital, Columbia University Medical Center and TriCore Labs. The nod will allow hospital labs, diagnostic providers and outpatient clinics to use its OLO blood analyzer, Sight said in a statement.
Today, blood samples are taken from patients in medical centers and sent to centralized labs for analysis, in which — depending on the nature of the test requested – they are handled by either automated machines or professional lab technicians. Eventually, results are sent back to the referring physician.
These automated machines are expensive, and the processing of samples in labs is slow, said Yossi Pollack, the co-founder and CEO of Sight Diagnostics, which seeks to improve blood testing methods, earlier this year.
Sight’s OLO is a new type of blood analyzer that promises the same accuracy as large laboratory machines but is cost effective and can be used at the point of care, giving physicians the results “in minutes,” the company said.
The complete blood count test (CBC) — which counts red blood cells, white blood cells, and platelets in a patient’s sample — is one of the most basic, informative tests a doctor can conduct.
“The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial,” said Dr. Carlo Brugnara, director of the Hematology Lab at Boston’s Children’s Hospital and professor of Pathology at Harvard Medical School, in the statement. “In rarer cases — involving acute leukemia, for instance — a CBC can make the difference between life and death.”
To use Sight’s product, the physician or nurse pricks the patient’s finger and places a drop of blood into a disposable plastic cartridge that is inserted into the OLO, which looks like a small home printer. The machine, equipped with a camera, takes thousands of images of the millions of cells within the sample. Software developed by the firm based on machine learning algorithms analyzes the images and provides the results in a printout or via email.
OLO’s FDA approval confirms its lab-grade performance using just two drops of blood — either a finger-prick or venous sample, the statement said. This, together with its compact size, makes the analyzer attractive in many clinical settings, the statement added.
“To treat children in our urgent care centers, a CBC is essential. OLO represents a major innovation in our laboratories’ CBC analysis,” said Dr. Steven Melnick, chief of Pathology at Miami’s Nicklaus Children Hospital, which is evaluating the technology. “At current volumes, we believe OLO will substantially reduce our costs.”
Sight’s success evokes the specter of another blood diagnostic firm — US-based Theranos, founded by Elizabeth Holmes. Theranos claimed it was able to perform a whole variety of blood tests — and not just the CBC analysis — using a small sample of blood from the finger, producing results in just a few hours and at a cheaper price than in labs.
But in 2018, the SEC charged Theranos, Holmes and a former company president with massive fraud following revelations by Wall Street Journal investigative reporter John Carreyrou that questioned the validity of the firm’s technology, claiming the US firm was using hacked traditional blood testing machines to run its tests instead of its own devices and alleging that the company’s own machines might provide inaccurate results.
In the Theranos case, FDA investigators concluded that, at the time of their research, there was not strong enough proof that the device could do what it was said to be able to do, according to a report by Business Insider.
How does Sight differ from Theranos, The Times of Israel asked Pollack, the CEO.
“We do not have firsthand knowledge of the Theranos case — so we refrain from drawing any direct comparisons,” he said in an email message.
“Sight is a technology-first company,” Pollack added. “We are driven by evidence and science — obtaining regulatory support along every step of our journey. Our recent FDA 510(k) clearance, for OLO, followed extensive clinical trials conducted at Boston Children’s Hospital, Columbia University Medical Center and TriCore Labs.
“Furthermore, our latest product was developed following almost a decade of research, and was preceded by our malaria product, which conducted almost 1,000,000 tests in the field, across 24 countries.”
Sight started its work with a machine that detected malaria via a finger prick of blood. The firm launched its first product, Parasight, in 2015. The device has received the European Union’s CE mark of approval.
Sheba Medical Center at Tel Hashomer will shortly start evaluating the Sight Diagnostic CBC analyzer in its lab, comparing its results with those of the Blood Counter DxH900 machine by Beckman-Coulter LTD which the lab generally uses, said Ram Doolman, director of the Laboratories Division and the Automated Mega-Laboratory at Sheba.
According to Sheba’s preliminary tests with the new technology, Sight’s solution “looks very promising,” Doolman told The Times of Israel.
“From what I know, Theranos never revealed its tech to anyone. They used to take the blood samples to their facility and issued the results without revealing the tech behind,” he said.
“To avoid similar analytical aberrations,” he said, labs must validate the technologies versus the original reference lab methods and see “if the results match the preliminary defined acceptance range.”
In general, “people should avoid companies that refuse to reveal their tech, even due to patent issues,” he added. In addition, he said, the Theranos claim that it could do all tests with just a small amount of blood was “not terribly credible from the beginning. Lab experts would suspect that it sounds too good to be true,” because different tests need different blood collections that need to be processed with “dissimilar anticoagulants.”
“Theranos never delivered,” and that was the alleged fraud, said Jon Medved, the CEO of OurCrowd, by phone. OurCrowd is a Jerusalem-based crowdfunding venture capital firm that invests in health technologies directly and via its Qure Ventures fund and its new Medtech fund.
Sight Diagnostics is one of the firms OurCrowd has invested in. “These guys are delivering,” he said, and the FDA clearance shows that the startup is “living up to its promise.”
The OLO analyzer is commercially available in Europe. Oxford University Hospital Trust is currently evaluating it in both its Surgical Emergency Unit and Oncology Clinic. Recently, Sight also initiated a pharmacy pilot program with major UK chain Superdrug to bring blood testing to its health clinics, the company said in its statement.
The Tel Aviv-based startup is also setting up partnerships in Africa, Asia, and South America, the statement said. The firm has been granted six US patents, with others pending, the statement said.
Sight also plans to ask the FDA to certify OLO for use in smaller practices and pharmacies in the United States, the statement said.