Sight Diagnostics today announced it has received US FDA 510(k) clearance to use its patented OLO analyzer, which performs a complete blood count using two drops of blood.
The FDA clearance gives hospital-run laboratories, diagnostic providers, and outpatient clinics the go-ahead to use the device, which captures around 1,000 images that are then interpreted by the company’s proprietary, automated algorithms.
OLO was first designed to detect Malaria and since 2012 has been used in more than 24 countries, according to the company. “Our technology was developed following a decade of research,” says Sarah Levy, Sight’s chief technology officer, noting that the company focuses on one test: the complete blood count, delivering results within minutes.
“Comparatively, using a traditional central laboratory test can take hours or, more often, days to deliver results,” Levy tells Xconomy.
To achieve 510(k) clearance, the company compared OLO’s performance with an FDA-cleared predicate device. Three clinical studies were conducted at Boston Children’s Hospital, Columbia University Medical Centre, and Tricore Labs. Hundreds of samples were run through OLO and the predicate device, Levy explains.
Moving forward, the company hopes to receive a CLIA waiver from the FDA so the device can be used in smaller practices and pharmacies. (The Clinical Laboratory Improvement Amendments, or CLIA, regulate laboratory testing).
“As part of the CLIA waiver application, the FDA requires Sight Diagnostics to run additional studies in the US to further demonstrate OLO’s simplicity and insignificant risk of erroneous results,” says Levy.
In the future, Sight says it also plans to explore OLO’s use as a companion diagnostic to support drug developers and as a tool to help enroll clinical trial participants. Discussions are in the early stages but no concrete plans are in place as of now.
The device is currently commercially available in Europe and is sold across five continents outside of the US. Levy says the feedback has been “overwhelmingly positive.”
Oxford University Hospital Trust’s Surgical Emergency Unit and Oncology Clinic is evaluating the device, and Sight also recently began a pilot program to bring testing to drugstore clinics in the UK.
The company has offices in Israel, the UK, and the US, and is hiring 14 new employees across these locations, according to its website. It also is establishing partnerships in Africa, Asia, and South America.