In Vitro Diagnostics (IVD)

Transforming precision medicine

Our proprietary technology enables real-time monitoring of biomarkers in exhaled breath condensate (EBC), plasma, blood, cells, and more enabling therapeutic response tracking and/or progress via desktop or mobile.

Point-of-care, low-cost testing empowers researchers and clinicians to develop precision medicine and personalize treatments for chronic respiratory and cardiovascular diseases including asthma, COPD, hypertension, and heart failure.

Our pipeline features two breakthrough tests that outperform existing gold standards, the BioSense AMD and BioSense VeNO, both backed by strong IP & clinical roadmaps for near-term scalability. 

Our 2-pronged approach revolves around scaling custom services and research kits then translating those kits into gold standard clinical tests.

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. Excessive production can generate reactive oxygen species like peroxynitrite, which damages tissue and lead to tolerances. 

BioLum is developing a point-of-care device to measure Vascular Endogenous Nitric Oxide (VeNO) in various samples including blood and cells. By monitoring nitric oxide and nitrative stress metabolites, our test aims to offer a personalized gauge of cardiovascular health, enabling early disease detection, personalized treatment plans, and improved patient outcomes for conditions like hypertension, HF, and PAH.

Beyond clinical care, the VeNO test supports researchers in developing new therapies that target nitric oxide signaling pathways, offering a critical tool for both real-world disease management and pharmaceutical innovation. 

Accurate measurement of endogenous nitric oxide (NO) facilitates:

  1. Early identification and prevention of CVD

  2. Streamline drug discovery and development of new donors

  3. Therapeutic guidance of cardiovascular disease

  4. Stratification of patients in clinical trials

  5. 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 EBC enables:

  1.  Inflammation monitoring on a continuous basis

  2. Prediction and prevention of exacerbations

  3. Rapid therapy-response assessment

  4. Patient stratification

  5. Early diagnosis and enhanced 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 & improve patients’ quality of life.

  • Save lives by providing early warning of exacerbation.

  • Prevent unnecessary hospital & office visits and returns.

  • Value in short & long term outcomes, decisions, disease management – Potential medical guideline changes

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