AI-based blood analysis tool geared towards decentralized diagnostics

When decentralized trials require measurement of vital signs and other important parameters, they often rely on the patients themselves to manage the devices that take the measurement. If so, study teams may be concerned about the ease of use, accuracy, and reliability of the devices.

With the Sight OLO Blood Diagnostic Analyzer, Sight Diagnostics introduced a test tool that would leverage traditional blood count (CBC) diagnostic technology to provide a tool that improves convenience, efficiency, precision and ease of use of previous devices. Sarah Levy, Technical Director of Sight Diagnostics, spoke to Outsourcing-Pharma about the technology and why such devices can elevate decentralized testing.

OSP: Could you share an overview of Sight Diagnostics: who you are, what you do, key capabilities and what sets you apart from the competition?

SL: Sight Diagnostics aims to decentralize diagnostics through fast, accurate and convenient blood tests. A complete blood count (CBC) is one of the most commonly ordered blood tests – with 4b tests ordered each year – because it helps healthcare providers accurately diagnose patients. Doctors rely on the CBC as the first line of questioning for patients with fever, low energy, and routine exams, as it helps refine the patient’s potential diagnosis.

Despite the ubiquity and bulk of CBC testing, today’s lab-grade CBC analyzers are bulky and bulky, requiring placement in a traditional lab environment. They also require skilled technicians to operate machines and perform extensive maintenance, including washing devices, calibrating, supplying, filling, and disposing of liquid reagents or wastes. These processes delay getting test results from hours to days, preventing providers from setting up effective patient care pathways.

Recognizing the need to bring rapid, lab-grade CBC testing to close-to-patient environments, Sight Diagnostics has developed Sight OLO, an AI-based blood diagnostic analyzer that delivers accurate CBC results from just two drops of blood in a few minutes. To develop Sight OLO, the Sight team took on the challenge of taking traditional CBC test equipment and completely revamping the underlying technology without compromising diagnostic accuracy. To make this technology scalable, the team designed a single-use cartridge that was affordable to manufacture and only required two drops of blood.

Sight OLO is also particularly compact and lightweight and operates from an electrical outlet, allowing the analyzer to be easily installed in hospitals and decentralized locations. Sight makes fast and accurate CBC testing accessible at scale, which means healthcare providers, in a variety of clinical settings, can leverage laboratory CBC results to make treatment decisions quickly and efficiently.

OSP: Tell us about Sight OLO, how does it work and what issues does it help users overcome compared to more conventional / traditional blood testing tools?

SL: Sight OLO takes a new approach to digital fluorescence microscopy that relies on a patented method of scanning blood, known as patented live single-layer imaging (LMI), which is an automated, simple, and inexpensive to create a living cell monolayer. Sight OLO is built with high power microscopes, computer vision and artificial intelligence, which allows it to deliver lab-quality results in a much more compact and efficient format than traditional CBC machines.

The analyzer’s computer vision technology produces over 1000 highly detailed images of blood from each blood sample. It then deploys fully automated AI algorithms to measure, classify and count the different cells and identify anomalies. As a result, Sight OLO measures 19 different parameters with 5 part differentials, making lab grade CBC testing available in various parameters.

Other technologies such as flow cytometry, for example, distinguish cell types using indirect measurements such as optical or electrical properties, requiring wet reagent management, cleaning, liquid removal, daily quality checks and highly qualified personnel for operation and management. These analyzers require a large footprint, capital investment, and service costs, and are not cost effective when used in low to medium volume test environments.

Alternatively, flow cytometry devices for near-patient environments are simply “miniature versions” of these larger devices, so they still require high maintenance and often do not offer the same level of precision. These devices are also prohibitively expensive for widespread adoption.

Sight OLO simply takes pictures of the blood sample and analyzes it with AI to deliver results in minutes, with the same level of precision as the popular Sysmex XN hematology analyzer. Sight’s AI technology and computer vision allow this blood analysis process to take place in a compact analyzer the size of a toaster oven. It operates from an electrical outlet and uses single-use cartridges without external management and disposal of liquid reagents, making it easier to use than traditional equipment.

Plus, user errors are mitigated by the Failsafe system and a touchscreen that guides operators through every step. The result is a convenient and accurate analyzer designed for decentralized settings.

Sight has collected nearly a petabyte of blood imaging data, which is used to improve Sight’s AI engine and unleash the unrealized potential of blood as a diagnostic tool. Sight is using the data to research a range of applications, including early detection of blood cancer and, most recently, the COVID-19 Severity Index.

OSP: What are the key applications of Sight OLO (especially in the clinical environment) and what (from your point of view) makes it particularly innovative?

Sarah Levy, Technical Director, Sight Diagnostics

SL: Sight makes the treatment paradigm much more efficient by reducing the steps required to treat patients and, in turn, lowering the overall cost to the healthcare system.

For example, oncology departments can use Sight OLO for cancer patients who need a CBC test before each chemotherapy treatment to monitor their white blood cell count. Instead of having patients go to a central laboratory, collect vials of blood, and wait days for the results, a healthcare professional can take two drops of blood, perform the test, analyze the results by a few minutes during the same office visit.

Sight OLO is so easy to use that anyone with minimal training can administer the test. In addition, the ability to offer a finger prick sample is important for babies or children three months and older, elderly patients and psychiatric patients, not all of whom are easy to administer a venous blood sample.

Sight OLO is deployed internationally in 37 countries in centralized environments, such as hospitals, and decentralized locations such as doctor’s office laboratories, emergency care centers, oncology clinics and clinics rural health. Sight’s technology is also particularly transformative in developing countries, helping to reconfigure treatment pathways in areas where skilled labor and supplies are scarce.

There is also huge potential for Sight OLO in decentralized companion diagnostics. For example, Sight works with pharmaceutical companies like Pfizer to improve patient adherence to treatment and with contract research organizations to support CBC testing needed in decentralized clinical trials.

OSP: Please explain how Sight OLO could help decentralized testing teams to optimize their results.

SL: Decentralized clinical trials (DCT) have the potential to shorten the time to trial completion, which ultimately lowers costs and speeds time to market for new therapies. When recruiting patients for clinical trials, organizers should screen potential patients to ensure they are healthy enough to receive the new treatment.

Then, during the trial, patients often need frequent monitoring of patients to ensure their health and their eligibility to continue receiving treatment. When the diagnostic test for this screening or surveillance is delayed, so is the clinical trial as a whole.

Sight OLO’s CBC test ensures screenings run quickly and accurately. By leveraging Sight OLO, trial organizers can reduce the number of follow-up appointments to enroll patients and lower overall costs when tests are performed on-site, rather than sent to a lab. For patients, this reduces the number of visits to outside laboratories, which is inconvenient and time-consuming. In addition, with results delivered in minutes, Sight OLO shortens the waiting time following a blood test.

Overall, this speeds up patient enrollment while increasing the enrollment rate, as more tests can be done in less time. Sight OLO can also provide effective monitoring of patients before and after treatment, minimizing the risk of adverse events occurring between blood tests and drug administration, thereby speeding up the entire clinical trial.

All of these benefits ultimately improve patient retention, a key factor in controlling overall costs and meeting trial deadlines.

OSP: Do you have anything else to add, whether it’s about the business, your technology, or the future of decentralized testing?

SL: Sight is now focusing on CBC testing. However, we envision a reality where more lab tests are available in environments close to the patient. And we think patients will be asking for it soon.

The pandemic has driven the design and execution of trials to accelerate and, as a result, has forced drug companies and CROs to reimagine how clinical trials are conducted. For decentralized clinical trials, the key to improving retention is to ensure that the clinical trial process prioritizes the patient.

The healthcare industry has adopted smart, patient-centric technologies, such as telehealth, bringing diagnostic tests closer to the patient, to tailor the delivery of care during the pandemic. There is an opportunity for technology to support the reinvented, patient-centered approach to clinical trials.

Diagnostics close to the patient, like Sight OLO which performs complete blood count tests from a finger prick in minutes, will play a critical role in this new decentralized, patient-centric design.

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