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Sight Dx Receives FDA Approval for CBC Analyzer, Plans US Commercial Rollout

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NEW YORK – Israeli firm Sight Diagnostics announced on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its OLO complete blood count (CBC) analyzer, and that it plans to start commercializing and selling the platform in the US.

The clearance allows the company to place its analyzer in laboratories run by diagnostic providers and hospitals. The OLO system uses digital fluorescent microscopy and machine-learning algorithms to capture and analyze images of blood drawn from a finger prick. According to the company, the artificial intelligence that conducts the analysis bases its evaluations on around half a petabyte of blood image data amassed over several years of clinical work.

CBC is one of the most commonly performed tests when patients go in for a wellness visit — it measures different components of blood, including red and white blood cells, hemoglobin, hematocrit (proportion of red blood cells to plasma), and platelets. Doctors use these measurements to evaluate a patient's overall health, as well as to diagnose or monitor diseases and infections.

The FDA clearance followed clinical trials at Boston Children's Hospital, Columbia University Medical Center, and Tricore Labs.

As was typical for a 510(k) review, the OLO analyzer was compared to a predicate analyzer that had already received 510(k) clearance in the past. The company placed OLOs in each of the three labs running clinical trials and ran hundreds of blood samples on both the OLO analyzer and the predicate lab-grade analyzers, covering all demographics and races, as well as a list of disorders that might affect blood cells, including leukemia and anemia, according to Sight Chief Technology Officer Sarah Levy.

Carlo Brugnara, director of the hematology lab at Boston Children's and a professor of pathology at Harvard Medical School, said the hospital has been doing studies with OLO for almost a year and a half, and he noted that it seems to perform well in comparison to more traditional CBC analyzers.

"It is really comparable in performance to analyzers that there are 50 times bigger than the small box of the Sight instrument. You get the analytical power of a very high-end instrument, but packaged in a small box that allows you basically to take that power out of the lab and bring it to any kind of setting where you could just perform a CBC in five or 10 minutes at the point of care, or in the pediatrician's office, or in the emergency room, or in oncology clinic," he said. "So, I think that's the huge advancement — the flexibility and easiness to use, and the fact that now this technology can be deployed in a variety of settings that before were not available when we've had these big humongous analyzers that are also quite complicated to operate."

While Sight is planning its move into the US market, OLO has been commercially available as a CE-IVD-marked platform in Europe for the past year. OLO is being adopted by private and public hospitals in Europe, and the company is seeing rising traction and growing customer demand, Levy said.

"We launched first in the UK, where OLO is being used by both private hospitals and the [National Health Service], and also in GP clinics," she said. "And we even initiated a pharmacy pilot with a major pharmacy chain to bring OLO to health clinics in the United Kingdom. Outside Europe, we have signed multiple partnerships and distribution agreements to bring OLO to markets in Asia, South America, Africa, and Australia."

The company has a similar plan for the US — while the FDA clearance only allows it to sell OLO to clinical labs, it intends to pursue a CLIA waiver in the next year that would allow it to place OLO in smaller doctors' offices and pharmacies.

Although CBC is often ordered by doctors through central or hospital labs, there is also a need for CBC testing to be available to doctors in smaller practices through point-of-care applications, to help them diagnose or monitor conditions, or make treatment decisions. Although a CBC test is relatively simple, getting results from an outside lab can take from 24 hours up to a week. In 2017, the FDA granted a CLIA waiver to Sysmex's XW-100 Automated Hematology Analyzer for CBC, which uses a 15 µL sample of venous blood. According to Sysmex, the turnaround time for results on its system can be as little as three minutes.

Brugnara noted that the OLO's ability to test a finger prick's worth of blood is a leap forward, especially for the purposes of testing children and neonates. "Clearly, one of the appealing features is the possibility of using a very small blood sample," he said. "Right now, if we want to do a CBC, we have to draw at least 2 ml of blood. Possibly, we can get away with a very small sample of less than 1 ml. And so, the use of the finger prick, it's really a big advancement for this purpose."

Before Sysmex received a CLIA waiver for its system, it received 510(k) clearance for its XW-100 analyzer as a point-of-care system in 2015. The subsequent CLIA waiver allowed the analyzer to be operated at doctors' offices, clinics, and other healthcare facilities by a wider range of support staff.

"[OLO] was designed to be as simple as possible for a minimally trained user," Levy said. "It's very compact, small, and requires almost no maintenance."

Indeed, Brugnara said, the most useful aspect of the analyzer is that a highly trained medical technologist is not required to operate it.

"I see the possibility down the line of this instrument being operated by a nurse or someone who is not necessarily a lab technologist," he said. "Right now, if you want to run a CBC, it has to be run in the lab, in a hematology analyzer, by a certified technologist. With this instrument, we are now in a kind of paradigm shift, in which we are going away from the highly complex setting of the lab and possibly moving this out in the field."

The analyzer itself is dry, Levy added. There are no reagents that are sold separately or that have to be added to the machine for its analysis. Instead, the company sells disposable test kits that contain everything that's needed for the testing reaction. All a doctor or technologist would have to do is add the sample and then insert the test kit into the analyzer.

The one area that could use some improvement is the occasional sample preparation step, Brugnara said. Usually, no sample preparation is required for the OLO. A droplet of blood from a finger prick is dispensed onto the surface of the test cartridge, and then the cartridge is loaded into the analyzer. But if more blood is needed — for example, in the case of a child in an oncology clinic getting a CBC test as one of a battery of other tests — and is drawn venously into a tube, there's an intermediate handling step that needs to happen that isn't necessary with other CBC analyzers.

"With current CBC analyzers, you take the tube, you load it into a rack, and then it's done," he said. "With [OLO] you have to agitate the blood so it's mixed, then you have to put an adapter into the tube, dispense a few drops of the blood sample onto the surface of the cartridge, and that then goes into the instrument. So, it requires the person to handle the tube, take out the blood, and then perform this dilution and load the cartridge. Ideally down the line, you want to have a system in which the cartridge is loaded automatically from the tube."

The company is aware this is an area for possible improvement, he added.  

For now, the company's sales targets for OLO are being kept under wraps. Levy said Sight plans to roll out the platform across the US. Although she declined to discuss specific pricing strategies, she noted that setup costs would likely include the one-time purchase of the analyzer and then continual repurchase of the consumable test kits.

"The pricing model changes according to the amount of tests being purchased and being used. But it's a very simple pricing model — we are basically selling all-inclusive tests," she said. "We find that in many clinical settings, adopting OLO can reduce costs significantly, especially in settings where the volume of blood tests per week is relatively low. We've seen specifically in a hospital setting where we ran a pilot, that we can cut the cost by half by placing in a department an OLO analyzer instead of using the service of the central laboratory."

Brugnara concurred. Although he isn't aware of what the company is planning to charge for the instrument, he believes it's likely to be far less than what a standard CBC analyzer would cost. Certainly, the OLO's throughput is different, he noted, so the analyzer wouldn't substitute for other instruments in a central lab that may have to run 100 samples an hour.

"I see it more as being deployed in areas that are turnaround-time sensitive or sample-size sensitive," he said. "So, it's a complement that the lab would certainly consider deploying outside of the lab in areas that years ago we would have thought, 'Can we put the big hematology analyzer in our oncology clinic?' Some institutions have gone that way, but usually it's a very expensive proposition because there's a huge capital investment and you need medical technologists to run it. So, if down the line now, this gives you a possibility of providing that service at a much cheaper cost, I think that's going to be a very appealing proposition for the lab."

Importantly, Brugnara added, this is likely to improve patient care as well. "If you can get something in 15 minutes rather than 45 or an hour, I think that there are some areas [in which this] is quite a change in the practice," he said.

Brugnara and his colleagues are looking at the possibility of using OLO in the hospital's emergency room, the neonatal intensive care unit, the children's oncology clinic, and possibly in associated pediatric practices — some of these uses will have to wait for Sight to receive its CLIA waiver, but they all involve settings where a faster turnaround time for CBC results would be beneficial for patients.

"Our oncology clinic is one that will be suited to have an instrument there, allowing patients to get their CBC results within 10 or 15 minutes from the time the sample is collected. I think, as well, the emergency room is an area in which we may be able to save 20 to 40 minutes from the regular CBC and get patients their CBC data back much faster," Brugnara said. "And in neonatal intensive care, we're doing these very small blood samples. So, anything that allows us to use less blood and to deliver those results faster, I think it's going to be beneficial."

Because the OLO is a CBC analyzer, Sight will use the standard billing code for CBC testing through insurance payors, Medicare, and Medicaid, so there's no need for a reimbursement strategy, even though the technology itself is new, Levy noted.

But OLO isn't Sight's only asset, she also said. An earlier version of the instrument, called Parasight, has been available in 24 countries for diagnosing malaria — the technology underlying both Parasight and OLO digitizes patients' blood samples and turns them into images.

"What we have is a huge amount of data. Just imagine turning blood samples into images — we have so much information on the cells, on their morphology, on the structure of the blood," Levy said. The ability to digitize blood samples has allowed the company to sell nearly 1 million malaria tests, and it's the basis for Sight's plan to sell tens of thousands of OLO CBC analyzers.

In the long term, Levy said, the company is aiming to use its ability to digitize blood and teach an AI to read the images to develop more tests.

"We intend to add more capabilities and applications in the future based on the information in those images that we are collecting in every standard complete blood count scan," she added, "things like identifying different types of anemia, like sickle-cell anemia, or detecting blood cancer at various stages, or novel markers in the blood. So, we're researching and developing more capabilities and applications for the future."