Problem Tech Solves

Visby Medical’s molecular diagnostic platform utilizes PCR for the qualitative detection of viral and bacterial infections, such as SARS-CoV-2 virus (COVID-19 test), and chlamydia, gonorrhoea and trichomonas (Sexually Transmitted Infections (STI) test). At the heart of Visby Medical’s focus is the human-centered design methodology, unlocking the power of PCR by making it palm-sized, eliminating the need for large instruments or separate readers, and streamlining the process to three simple clicks – three purple buttons with large visual prompts “1 - 2 - 3” provide user guidance and reinforce the simple steps to initiate the test. Until recently, the two main choices for infectious disease detection weren’t meeting the need for both fast and accurate testing: molecular testing, (PCR is the gold standard) offers high accuracy but low speed; antigen testing offers lower accuracy but high speed. With PCR, doctors must treat empirically without test results, then track patients down later to communicate a diagnosis, often needing to change the prescription. With antigen testing, doctors may potentially begin treatment but often find the tests require additional confirmatory molecular testing. This may ultimately provide a different result due to higher accuracy, requiring doctor and patient to rework the treatment plan. This trade-off isn’t the case in other areas of medicine. For example, an oncologist would never prescribe chemotherapy without an accurate diagnostic result. Yet when it comes to infectious diseases, doctors are forced to trade off accuracy for speed and start a patient on treatment to get the ball rolling.

Tech Brief

Small. Fast. Deployable. Visby’s miniaturized on-demand technology helps create a better way for clinicians to diagnose and manage infectious diseases right where it’s needed, at the point of care. This improves clinical decision-making and patient outcomes, reducing the spread of infection, while providing greater safety for public health by enabling contact tracing before the patient leaves the test setting. These factors ultimately have an impact on reducing healthcare costs. In November 2020, The Lancet, Infectious Disease journal, validated the test and its ability to provide fast, accurate results in under 30 minutes, directly at the point of care. In fact, the Lancet noted that Visby Medical’s device “is potentially the new gold standard for point of care tests for infectious diseases such as STIs and influenza and coronavirus infections, in which rapid turnaround is key.” ​ The platform has now been adapted for two separate applications, using PCR for bacterial infections (clinical studies: chlamydia, gonorrhea, and trichomonas) and reverse transcription (RT) PCR for viral infections (COVID-19). What’s more, Visby plans to adapt it for any number of serious infections. Designed portability means Visby’s test can help increase access — democratize diagnostics — with user-centric design to help ensure ease-of-use for anyone to operate anytime, almost anywhere.

Tech Differentiators

Visby Medical’s diagnostic platform targets healthcare professionals looking for more effective methods of testing for viral or bacterial infections, such as COVID-19 and STIs. The ground breaking technology, covered by 15 patents (and counting), received FDA Emergency Use Authorization (EUA) for use in any laboratory with a CLIA Certificate of Waiver, which includes doctor’s offices, mobile labs/clinics, surgical centers, and nursing homes. In a class of its own, Visby’s platform is the only instrument-free (all-in-one), single use PCR test available to healthcare professionals in CLIA-waived settings. Accurate results can ensure the clinician is able to make informed decisions that can shorten infection duration, prevent transmission, and may lower the risk of complications, all while improving the patient and physician experience. Visby remains steadfast in gaining government and private partnerships to further accelerate the delivery of PCR-grade diagnostics to their customers, designed for use at the point of care. Visby created its diagnostic platform with patients in mind, as patients are central to its mission to change the order of diagnosis and treatment of infectious diseases. Visby is working to eventually provide accessible, fast and accurate testing to patients at home, particularly those who do not have access to testing in high complexity labs.



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