What is the common denominator between urinary tract infections (UTIs), kidney stones, and heart failure? Detecting these potential health problems is possible through the analysis of urine. 80% of all women will have a UTI at some point in their lives, and they are often recurring. Moreover, women over the age of 70 are 70% more likely to suffer from an infection. In the U.S., 1 in 10 men will suffer from kidney stones, and for men over the age of 70, the chances increase by 6-fold. Heart failure on the other hand is the cause of death of almost 15% of people in the U.S.

Many times, the detection of these health problems only happens after the onset of symptoms, when patients feel some sort of discomfort and therefore go to get it checked out. But early detection is possible. For example, in men, kidney stones can be detected weeks before the onset of pain, and women can avoid the advancement of a UTI to a full-blown infection by drinking cranberry juice. With early detection of these conditions, simpler treatments, such as the use of antibiotics, can easily be administered before they escalate. If early detection does not occur and such conditions worsen, patients often experience immense pain, trouble walking, eating, and drinking, and often need to be hospitalized for weeks on end. Olive Diagnostics invented a device that helps detect the early onset of these diseases through urine analysis.

Olive Diagnostics has developed an affordable Internet of Medical Things (IoMT) device, called KG, that mounts to any toilet. It detects urine's molecular composition and generates secure and personalized diagnostic data in real-time. It is a purpose-built, multi-frequency spectrometer made from off-the-shelf components that can identify 3,100 molecules in urine. Using cloud-based AI technology, KG calculates molecule concentrations through proprietary algorithms, analyses and tracks collected data, and alerts users to any changes or anomalies in real-time. The system generates information on molecular factors such as red blood cells, protein, ketone, creatinine, etc., as well as other urine characteristics such as volume, pressure, colour, and frequency. It can accurately detect biomarkers for prominent medical conditions and diseases that include certain types of cancers related to the prostate, ovaries, and kidneys; heart failure; dehydration; kidney stones; inflammation in the urinary bladder, and other conditions. If there are biomarkers detected that signal urgent attention or pre-symptomatic issues, the device alerts users, sometimes weeks before symptoms.

KG illustration. Credit: Olive Diagnostics 

The KG device can be used at home, or in any clinical environment such as assisted living facilities, outpatient facilities, and hospitals. It can even detect more mundane issues, such as dehydration or provide insights regarding bowel movements, and is, therefore, an invaluable tool for both patients, their family members or caretakers, and medical staff. These kinds of diagnoses can be particularly important for the elderly, where early detection of certain diseases can really improve the quality of life and of care. No to mention, it also saves money because it can lead to reduced hospitalization.

The greatest value the KG device offers is its ability to monitor urinations continuously; every time a person urinates, data is collected which leads to the creation of a highly granular, personalized individual profile. As Dr. Joseph Rosenblum, Medical Director at Maccabi Entrepreneurship said, “Urine is a central part of medicine and health monitoring, but current solutions are cumbersome and offer limited tracking analysis or access to medical history.” Olive diagnostics is looking to change that.

This week (Feb. 1st), Olive Diagnostics announced that it has completed a successful clinical trial for their KG product by TechnoSTAT Clinical Services, an international clinical trial management and monitoring company, in Hadassah Ein Kerem Medical Center in Jerusalem. The clinical trial was designed to correctly check the system's ability to detect protein in urine in more than 900 samples. TechnoSTAT performed third-party validation on its models. The trial showed that the KG delivered a sensitivity rating of 92.8% (positively identifies the specific molecules present) and a 95.5% specifically rating (identifies specific molecules that are not present) on a single test, and a 98.7% sensitivity rating and a 100% specificity rating of on 5 ‘daily simulated’ urinations. It is, therefore, more accurate than urine sticks that constitute the gold standard for home-based diagnosis. The company has also completed its ISO 13485 certification, which is a critical milestone necessary for CE certification that will enable Olive Diagnostics to commercialize its technology and commence sales in the European Union, while they are also in the FDA pre-submission phase for the United States.

Olive Diagnostics was founded in 2019 by Guy Goldman (CEO) and Corey Katz. The startup’s team includes experts in biochemistry, chemistry, physics, data analytics, optics, and business development for the health and wellness markets. They have raised $4 million in pre-seed and seed funding from Maccabi Healthcare Services, Cleveland Clinic, the Israel Innovation Authority, eHealth Ventures, Amgen Ventures, alongside private European and American investors, and hope to raise more in a Series A round during the first half of 2022.