When decentralized trials call for the measurement of vital signs and other important metrics, they frequently rely on the patients themselves to handle the devices that do the measuring. If that is the case, study teams may worry about the devices being easy to use, accurate, and reliable.
With the Sight OLO blood diagnostics analyzer, Sight Diagnostics has introduced a testing tool that reportedly builds upon traditional complete blood count (CBC) diagnostics technology to come up with a tool that improves upon the convenience, efficiency, accuracy, and ease of use of previous devices. Sarah Levy, chief technical officer of Sight Diagnostics, spoke with Outsourcing-Pharma about the technology, and why such devices can elevate decentralized trials.
OSP: Could you please 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 testing. Complete blood count (CBC) is one of the most commonly ordered blood tests -- with 4b tests ordered annually -- because it helps healthcare providers accurately diagnose patients. Doctors rely on CBC as the first line of questioning for patients with fevers, low energy, and routine checkups because it helps narrow down the patient’s potential diagnosis.
Despite how ubiquitous and essential CBC tests are, current lab-grade CBC analyzers are large and cumbersome, requiring placement in a traditional lab setting. They also require trained technicians to operate the machines and conduct extensive maintenance, including device washouts, calibration, procuring, refilling, and disposing of liquid reagents or waste. These processes delay getting test results from hours to days, preventing providers from configuring efficient patient care pathways.
Recognizing the need to bring rapid, lab-grade CBC testing to near-patient settings, Sight Diagnostics developed Sight OLO, an AI-based blood diagnostics analyzer that offers accurate CBC results from just two drops of blood in minutes. To develop Sight OLO, the Sight team took on the challenge of taking traditional CBC testing equipment and completely reengineering the underlying technology without compromising the 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 uniquely compact and lightweight and operates from an electrical plug, allowing the analyzer to be easily set up throughout hospitals and in decentralized locations. Sight is making fast, accurate CBC testing accessible at scale, meaning that healthcare providers, across different clinical settings, can leverage lab-grade CBC results to make treatment decisions quickly and effectively.
OSP: Please tell us about Sight OLO, how does it work and what issues does it help users overcome compared to more conventional/traditional blood analysis tools?
SL: Sight OLO takes a novel approach to digital fluorescent microscopy that leverages a patented method of digitizing blood, known as patented live monolayer imaging (LMI), which is an automated, simple, and low-cost method for creating a monolayer of live cells. Sight OLO is built with high-powered microscopes, computer vision, and artificial intelligence, allowing 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 1,000 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 abnormalities. As a result, Sight OLO measures 19 different parameters with 5-part differentials, making lab-grade CBC testing available in various settings.
Other technologies like flow cytometry, for example, distinguishes cell types using indirect measures such as optical or electrical properties, requiring wet reagent management, clean up, liquid disposal, daily quality control checks, and highly trained staff to operate and manage. These analyzers require a large footprint, capital investment, and service fees and are not cost-effective when used in low to medium volume test settings.
Alternatively, flow-cytometry devices for near-patient settings are simply ‘miniature versions’ of these larger devices, so they still require high maintenance and often do not provide the same level of accuracy. These devices are also cost-prohibitive for wide-scale adoption.
Sight OLO simply takes pictures of the blood sample and analyzes it with AI to provide results in minutes, with the same level of accuracy as the renowned 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 plug and uses single-use cartridges without external liquid reagent management and disposal, making it easier to operate than traditional equipment.
Plus, user error is mitigated by the Failsafe system and a touch screen that walks operators through every step. The result is a convenient, accurate analyzer designed for decentralized settings.
Sight has collected close to a petabyte of blood imagery data, which is being used to improve Sight’s AI engine and unlock the unrealized potential of blood as a diagnostic tool. Sight is leveraging the data to research an array of applications, including the early detection of blood cancer, and recently the severity index of COVID-19.
OSP: What are the key applications for Sight OLO (especially in the clinical environment), and what (from your perspective) makes it especially innovative?
SL: Sight is making the treatment paradigm much more efficient by reducing the steps needed to treat patients and, in turn, reducing 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 chemo treatment to monitor their white blood cell count. Instead of having patients go to a central lab, draw vials of blood, and wait days for results, a healthcare worker can take two drops of blood, run the test, analyze the results within minutes during the same office visit.
Sight OLO is so simple to use that anyone with minimal training can administer the test. Plus, the option to offer finger-prick sampling is significant for babies or kids three months and older, elderly patients, and psychiatric patients, all of whom aren’t easy to administer a venous blood sample.
Sight OLO is deployed internationally in 37 countries in centralized settings, like hospitals, and decentralized locations such as physician office labs, urgent care centers, oncology clinics, and rural health clinics. Sight’s technology is also particularly transformative in developing countries, helping reconfigure treatment pathways in areas where skilled labor and supplies are scarce.
There is also enormous potential for Sight OLO in decentralized companion diagnostics. For example, Sight works with pharmaceutical companies like Pfizer to improve patient adherence to therapy and with contract research organizations to support necessary CBC testing in decentralized clinical trials.
OSP: Please share how Sight OLO might help decentralized trial teams optimize their results.
SL: Decentralized clinical trials (DCTs) can potentially shorten the completion timeline of the trial, which ultimately reduces costs and gets new therapies to market faster. During the recruitment of clinical trial patients, organizers need to screen the potential patients to ensure they are healthy enough to receive the new therapy.
Then, during the trial, patients often require frequent patient monitoring to ensure their health and eligibility to continue receiving treatment. When the diagnostic test for that screening or monitoring is delayed, so is the clinical trial as a whole.
Sight OLO’s CBC test ensures screenings happen quickly and accurately. Leveraging Sight OLO, trial organizers can reduce the number of follow-up appointments to enroll patients and reduce overall costs when tests are performed onsite, rather than sent out to a laboratory. For patients, this reduces the number of visits to outside laboratories, which is inconvenient and time-consuming. Plus with results delivered within minutes, Sight OLO shortens the subsequent waiting time after getting blood work done.
Overall, this expedites patient enrollment while increasing the enrollment rate because more tests can be done in a shorter time. Sight OLO can also provide efficient patient monitoring pre and post-treatment, minimizing the risk of adverse events occurring between blood testing and drug administration, speeding up the whole clinical trial.
All of these benefits ultimately improve patient retention, a key factor to control overall costs and meet trial timelines.
OSP: Do you have anything else to add, either about the company, your technology, or the future of decentralized trials?
SL: Sight is, today, focused on CBC testing. However, we envision a reality where more laboratory tests are available in near-patient settings. And we believe patients will soon demand it.
The pandemic has pushed to accelerate trial design and execution, and, as a result, has forced pharmaceutical companies and CROs to reimagine how clinical trials are run. For decentralized clinical trials, the key to improving retention is ensuring the clinical trial process puts the patient first.
The healthcare industry has embraced intelligent, patient-centric technologies, such as telehealth, bringing diagnostic testing closer to the patient, to adapt care delivery during the pandemic. There is an opportunity for technology to support the re-imagined, patient-centric clinical trial approach.
Near patient diagnostics, like Sight OLO that runs complete blood count tests from a finger prick of blood in minutes, will play a vital role in this new decentralized, patient-first design.