FDA clearance positions Sight Diagnostics to deliver on two-drop blood testing promise

Today’s news that Sight Diagnostics secured 510(k) clearance for its Olo analyzer certainly will reduce the flow of future patient tears and fears as the system requires just two drops of blood to conduct a range of tests.
However, the clearance — which confirms the Olo works just as well as gold-standard lab-grade systems in completing the Complete Blood Count analysis — also positions the Tel Aviv, Israel–based company to disrupt the collection, analysis and, ultimately, the storage of healthcare data found in blood, creating opportunities for unique partnerships.
The secret lies in how the blood is tested. Rather than trying to simplify and shrink the pumps, tubes and other machinery used in traditional blood analysis — as Theranos infamously claimed it could do — Sight Diagnostics is capturing digital images of the blood.
Then, just as radiologists now do on a larger scale with X-rays and other images, the Olo uses artificial intelligence to characterize the number of red blood cells, white blood cells, and platelets in a patient’s blood sample. The Olo can quickly detect viral infections, bacterial infections, anemia and forms of blood cancer. It’s also been used to screen blood samples for malaria.
Resembling a squat Keurig coffee maker, the Olo — like the Keurig — reduces a complex process into one simple step; insert a disposable cartridge with a blood sample in the machine and get a quick, clean analysis of blood.
“In the end, this Olo is just a box with a computer, a microscope and a cartridge that go in and out,” said Sarah Levy Schreier, the company’s CTO. “There is nothing to maintain, to clean. There are no reagents involved.”
With FDA approval in hand, the company expects to begin selling to hospitals. The Olo could be located in the hospitals’ central laboratories, but they’re small enough to be placed in departments that have high demand but no space for traditional testing equipment.
Outside the U.S., Sight sells into private and public hospitals, pharmacies and outpatient clinics. The company sells units in Europe, South America, Asia, Africa and Australia.
In the U.S., the company is seeking a CLIA waiver to sell directly to doctors’ offices and clinics in the U.S. The company will need to conduct additional clinical trials located in point of care centers to secure that approval, Levy said.
By using digital technology, Sight Diagnostics promises to not only expedite blood screening but also create a new market for blood analysis,  Levy said.
“We have very good quality of images that allow us to see what is in your blood very well,” Levy said. “We’re not aware of another player that collects those images and digitizes blood the way we’re going it.”
But more intriguing, Levy said Sight Diagnostics has been capturing images in its clinical trials to build the largest dataset of blood images in the world. The digital records enable Sight to save much of the data that’s lost with traditional testing, she said.
“When the blood flows through those huge machines, there is a sensor that translates what flows through it to very few parameters so the whole set of information is translated into 10 numbers” used to assess a patient’s overall health, she said.
By saving images of the blood, Sight retains all that data. “We just have all that translated into the images,” she said. “We save the data that is stored in the blood. That the potential, that’s the big advantage of this method.”
To be sure, the company will use the database to look for new diagnostic tests. However, Sight Diagnostics also is looking to partner with clinical institutions that have other applications, like potentially using digital images as part of medical records. “In the future, we will look to collaborate with other partners that will help us develop AI-based applications using that data,” she said.
The company’s founders previously used “computer vision” and intelligence in another revolutionary endeavor – driver-assisting technologies in cars. Yossi Pollak, co-Founder and CEO, previously worked at Mobileye, the world-leader in developing driver-assisting systems. Intel acquired the company for $15 billion.
Pollak sought to bring the power of “computer vision” to medicine and paired with Daniel Levner, PhD, to start the company. Levner was a scientist at Harvard’s Wyss Institute for Biologically Inspired Engineering. He co-founded two other biology and engineering companies, and trained with George Church.
Sight Diagnostics targeted malaria test first because of the huge demand and the fact that the virus presented a clear target for its nascent AI-platform. It proved quickly proved to be an effective way of diagnosing malaria, enabling the company to nearly a million tests in 24 countries.
In 2014, Levy joined to move the company into complete blood count tests. The company employees more than 75 people in offices in Israel, France and the U.S.
Earlier this year, the company secured nearly $28 million, according to VentureBeat, bringing its total raise to over $50 million. Levy said the company will be in the market for more.
“We have always been very capital efficient,” she said. “But we will definitely raise more funds now that we enter our next phase of growth. We are definitely looking at opportunities.”
Levy said the Theranos story certainly could be heard in the background while Sight was developing Olo — but Sight brought in the data scientists, performed the right science, and worked with regulatory agencies to get things right. “We were just taking a different approach from the start,” she said.
Original Article: (https://www.massdevice.com/fda-clearance-positions-sight-diagnostics-to-deliver-on-two-drop-blood-testing-promise/)