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Sight Diagnostics Receives FDA Clearance For Blood Test Device

By Benjamin Ross 

December 6, 2019 | Since Theranos' fraudulent blood test was exposed in 2015, companies developing similar tests meet a certain level of skepticism. But Sight Diagnostics' CTO, Sarah Levy, is unfazed.  

"[Theranos] tried to solve an important problem," she tells Diagnostics World. "An accessible, pain-free blood test is a real need and it's a big challenge." 

Sight approached the blood test the old-fashioned way, says Levy. No hype, just science. 

"There's scientific DNA embedded in the company," she says. "We're driven by data, clinical evidence... and we've taken a patient, step-by-step approach [to our work]." 

That patience appears to have paid off, as the company's AI-based blood diagnostics device—called OLO—recently received 510(k) clearance for the US Food and Drug Administration (FDA), allowing the device to be marketed and sold in the US. Sight has previously established partnerships in Africa, Asia, South America, and the UK. To date, the company has conducted nearly 1 million tests in 24 countries, according to Levy. 

The next stage for Sight is to receive a CLIA waiver from the FDA, which would certify OLO for use in smaller practices and pharmacies in the US. 

OLO performs a Complete Blood Count (CBC) in minutes, while also providing lab-grade results. The company says the device is compact, easy to use, and cost effective in low-volume settings—ideal for moderately complex labs. 

Prior to the 510(k) clearance, Sight had been conducting clinical trials at Boston Children’s Hospital, Columbia University Medical Center and Tricore Labs after spending over a decade developing the technology. 

The process is straightforward, says Levy. "We've digitized microscopy, building an analyzer that takes images of the patient's blood and analyzes those images in real-time to detect, measure, and count the different blood cells." 

This analysis is done using just two drops of blood from a fingerprick, she explains, which are loaded into disposable cartridges. The entire process takes around 15 minutes. 

Levy says capturing CBC provides a wide range of research possibilities, making an effective test highly valuable. Around 4 billion CBC tests are run worldwide every year, she says. 

"[CBC tests] count the different cells and components in the blood, and it's a critical ingredient in almost any diagnostic process," says Levy. "For instance, it can provide numbers for white blood cells, which can present an image of how the immune system is working. First indications of leukemia are also found in CBC." 

Despite CBC being a somewhat prevalent globally, Levy says an automated version of the test has not been widely available. Most CBC, especially for infectious diseases like malaria, have been done manually in recent years, increasing the demand for devices like OLO as the number of tests for diseases continue to rise. In fact, malaria was the focus for Sight as they began the initial development of their test. 

"There're over 500 million tests for malaria, globally, and it's still the number one fatal infectious disease in the developing world," says Levy. "An accurate diagnostic tool seems like something we will be able to implement relatively easily using computer vision technology [such as what we offer with OLO]." 

Levy is optimistic about the future for Sight, with regulatory support giving the company confidence as they continue to build their infrastructure for future capabilities. 

"Our mission now is to place tens of thousands of these analyzers throughout the US and in developing countries," she says. "It's a very exciting time for us."

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