Clinical In Vitro Diagnostics
Transforming precision medicine
Our proprietary technology enables real-time monitoring of biomarkers in exhaled breath condensate (EBC) and blood, providing users with the ability to track treatment progress on a desktop or mobile device. This empowers researchers and clinicians to develop precision medicine and personalize treatments for chronic respiratory and cardiovascular diseases such as asthma, COPD, hypertension, and heart failure. With a point-of-care, low-cost platform, we are revolutionizing healthcare and making a lasting impact on patient lives, in line with our ultimate vision. We currently have two clinical products in our pipeline, the BioSense AMD and BioSense VeNO.
Our 2-pronged approach revolves around scaling custom services and research kits then translating those kits into gold standard clinical tests. Proprietary technology enables real-time monitoring of biomarkers in exhaled breath condensate (EBC) and blood, providing users with the ability to track treatment progress on a desktop or mobile device. This empowers researchers and clinicians to develop precision medicine and personalize treatments for chronic respiratory and cardiovascular diseases such as asthma, COPD, hypertension, and heart failure. With a point-of-care, low-cost platform, we are revolutionizing healthcare and making a lasting impact on patient lives, in line with our ultimate vision. We currently have two clinical products in our pipeline, the BioSense AMD and BioSense VeNO.
A modern approach
IVD Products
BioSense VeNO
BioSense VeNO (Vascular Endogenous Nitric Oxide) – A testing platform to monitor cardiovascular disease
Cardiovascular disease is the leading cause of death worldwide and costs the U.S. $219B+ annually. 47% of Americans are at-risk of developing cardiovascular disease and stroke, and risk factors include high blood pressure, high cholesterol, and smoking.
Vascular endogenous nitric oxide (VeNO) is a fundamentally important gas that the cardiovascular system uses to regulate blood pressure and promote healthy function, but VeNO levels are misregulated in many diseases including heart disease, hypertension, stroke, and erectile dysfunction. Uncontrolled production of NO can lead to the generation of reactive oxygen species like peroxynitrite that damage tissue and lead to tolerance.
BioLum is developing a point-of-care device and assay to measure and monitor VeNO from a finger-prick of blood to help patients identify cardiovascular disease early, manage their condition, and help clinicians personalize treatment to improve patient outcomes and reduce disease progression. Our blood analysis product, the VeNO (vascular endogenous nitric oxide) test, measures nitric oxide and nitrative stress metabolites in the blood.
A remote VeNO test will help guide the development of new therapies that target nitric oxide signaling pathways. The VeNO test will provide physicians, researchers, and patients with a critical, personalized gauge of cardiovascular health, for the identification and treatment of diseases such as hypertension, heart failure, and pulmonary arterial hypertension (PAH), and chronic thromboembolic pulmonary hypertension (CTEPH).
A simple, accurate measure of endogenous nitric oxide (NO) will facilitate:
Early identification and prevention of CVD
Streamline drug discovery and development of new donors
Therapeutic guidance of cardiovascular disease
Stratification of patients in clinical trials
Identification of patients likely to benefit from therapy
BioSense AMD
BioSense AMD (Airway Monitoring Device) – Testing platform to measure lung function for chronic respiratory disease
Chronic lower respiratory diseases including asthma, COPD, emphysema, and pulmonary hypertension are the fourth leading cause of death in the United States, and a leading cause of death worldwide across all countries and income levels. There are approximately 339M people in the world with asthma and 25.2M people in the U.S. There are approximately 251M people in the world with COPD and 15.3M patients in the U.S.
Our breath analysis product, The BioSense AMD (Airway Monitoring Device) is a point-of-care device for rapid and quantitative measurement of hydrogen peroxide in exhaled breath condensate, a biomarker of airway inflammation, eosinophil and neutrophil infiltration in the lungs. Studies show that frequent, objective measurements of lung function offer significant patient benefits, while also providing physicians and researchers a better understanding of disease states through valuable, patient-generated data. Additional clinical endpoints will help further parse out the different disease phenotypes.
Measurement of H2O2 (Hydrogen Peroxide) in condensate enables stakeholders to:
Monitor inflammation on a continuous basis
Predict and prevent exacerbations
Rapidly assess therapy response
Stratify patients
Early diagnosis and disease management
Biomarker Analysis Benefits Multiple Stakeholders
Primary Care & Specialists:
Personalized treatment and improved health outcomes
Clinical decision support for early diagnosis
Personalized – more accurate diagnosis and treatment
Simple, direct measures of drug efficacy to quickly control symptoms
Early ID - prevent exacerbations and repeat office visits
Quantitative understanding of disease
Patients
Remote care technologies enable preventative care
At-home monitoring provides frequent, objective measurements of disease state
Track disease progression, track daily airway inflammation
Identifying warning signs of triggers & exacerbations at home
Optimize treatment more efficiently and improve symptom control
Payers
Discover patients who may benefit from therapies with complementary diagnostics & decision endpoints
Streamline patient care by monitoring drug efficacy to accelerate therapy optimization & improve patients’ quality of life.
Save lives by providing early warning of exacerbation.
Reduce costs by preventing unnecessary hospital & office visits
Value in short & long term outcomes, decisions, disease management – Potential medical guideline changes
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