According to a story from BioPortfolio, the company Mologic Ltd recently announced that its clinical trial to test HeadsUp, its urine-based diagnostic tool, is starting. The clinical trial will specifically be using HeadsUp in an attempt to detect pulmonary exacerbations in patients with cystic fibrosis. The trial is also meant to confirm the effectiveness of the innovative point-of-care test so that patients can monitor their condition themselves.
About Cystic Fibrosis
Cystic fibrosis is a genetic disorder with wide-ranging effects; however, it is primarily characterized by its impact on the lungs. People with cystic fibrosis experience the abnormal buildup of thick, stick mucus in the lungs, causing progressively worsening breathing problems and increasing their vulnerability to infection. It is caused by a mutation of the CFTR gene. Symptoms of the disorder include poor growth and weight gain, salty skin, thick, sticky mucus in the lungs, lung and sinus infections, clubbed digits, male infertility, coughing, shortness of breath, and fatty stool. Treatment involves therapy to maintain lung function and a constant regimen of antibiotics to fight infection. A lung transplant may be an option in the later stages. Life expectancy is in the 40s or 50s for most patients. At this juncture, there is no cure. To learn more about cystic fibrosis, click here.
About Pulmonary Exacerbations
A pulmonary exacerbation describes an instance in which lung function becomes noticeable worse over a relatively brief period of time, making breathing difficult. These exacerbations are unusual as cystic fibrosis generally progresses fairly slowly. Regardless, these exacerbations can be challenging for the patient and are irreversible. Therefore, it is valuable for patients to understand when such an event has occurred.
About the Clinical Trial
The trial will recruit from West Midlands Adult CF Centre in Birmingham, UK, which takes care of as many as 360 adult patients with cystic fibrosis. The HeadsUp test will analyze five distinct biomarkers found in urine in order to determine whether an exacerbation has occurred and a patient is in need of treatment. If successful, the test will allow patients to monitor their disease using a non-invasive testing platform without the need for a visit to their doctor. This will allow for earlier intervention when necessary and reduce the possibility of unnecessary lung damage.
You can read Mologic’s original announcement here.