ProLung’s mission is to improve outcomes for potential lung cancer patients through early predictive technologies, provide cost savings to patients, payers, and providers, and to provide a fair return on investment to shareholders and other stakeholders.
ProLung is committed to making a positive and significant impact on the healthcare community and to being socially responsible in all its endeavors.
The ProLung Test uses precision proprietary volume-averaging bioconductance technology to measure the difference in conductivity between malignant and benign lung tissue. The data is analyzed to produce a personalized and predictive score indicating the likelihood of malignancy in the lungs.
There is a severe unmet clinical need to reduce the time required to determine malignancy in patients diagnosed with Indeterminate Pulmonary Nodules (IPNs). Patients with IPNs wait months, or even years, receiving multiple CT scans to confirm malignancy in the lungs. This wait often proves fatal.
In 2015, the US Preventative Services Task Force and Centers for Medicare and Medicaid Services (CMS) implemented the first national lung cancer screen utilizing a low-dose CT scan (LDCT) of the chest. The screen will amplify this clinical need as it identifies up to 24 million patients with IPNs who will experience a narrowing treatment window as they wait.
The ProLung Test has the potential to reduce the waiting time from up to 3 years to 1 day.
- No radiation
- 25 minute test
- Immediate results
- Risk stratification
- Peace of mind
In most cases, a nodule is discovered incidentally following a chest x-ray or computerized tomography (CT) scan or through a chest CT screen. The patient then undergoes one of two methods for follow-up:
- The mass is monitored for growth using repeated CT scans every three to six months for 3½ years. This exposes the patient to radiation and carries a high potential for false positive results, which may subsequently lead to unnecessary biopsies and procedures.
- The mass is monitored using Positron-Emission Tomography (PET) scans over a similar period of 3½ years. This method has numerous limitations, however, depending on the size, inflammation levels, and metabolic activity of the tumor.
After sufficient risk is finally confirmed from repeat CT or PET scans, a biopsy is performed and a formal diagnosis is made.
The ProLung Approach
The ProLung Test is indicated to follow a CT scan that has identified an indeterminate pulmonary nodule suspicious for cancer. The Test may provide immediate risk stratification in the form of a predictive composite score which indicates the likelihood of malignancy in the lung tissue.
If the risk score indicates high risk, the physician may be able to accelerate the patient to a biopsy and diagnosis, thus expanding the therapeutic window; or if low risk, to a more relaxed CT surveillance program and greater peace of mind for the patient.
The ProLung Test has the potential to reduce the waiting time from up to 3 years to 1 day, eliminate excess repeat CT scans, and accelerate high risk patients to biopsy and effective treatment options.
The primary study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.
For more on ProLung, visit the company’s website.
Categories: Ideas & Technologies