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Blood Biomarkers Determine Response in Cystic Fibrosis Patients

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NJH ID: #08-22

Cystic fibrosis (CF) is a genetic disorder that affects approximately one out of every three thousand newborns in populations of European descent. It is the most common lethal inherited disease in the western world. The median life expectancy for this disease has increased to 46 years, for patients born between 2015-2019 (Cystic Fibrosis Foundation 2020 Patient Registry). Respiratory failure continues to be the main cause of death in this patient population.

The major complications in CF are airway obstruction with mucus, chronic endobronchial infection with pathogens such as Pseudomonas aeruginosa, and severe airway inflammation. Acute pulmonary exacerbations are also common in CF and contribute to loss of lung function.

There is a critical need for new effective anti-microbial and anti-inflammatory therapies to mitigate the progression of this disease. However, assessment of treatment outcomes is currently limited to standard practices based on Forced Expiratory Volume (FEV1) and C-Reactive Protein (CRP) measurements. This approach lacks sensitivity and therefore is not suitable to reliably determine the efficacy of drug treatments in CF patients or other diseases associated with airway inflammation.


Physician scientists at National Jewish have identified a novel panel of leukocyte gene biomarkers associated with CF pulmonary inflammation. A clinical study performed in CF patients at National Jewish showed that circulating leukocyte expression of this gene panel is particularly useful in quantifying therapeutic response and predicting disease resolution in response to treatment of acute pulmonary exacerbations. This blood-based diagnostic test is highly reproducible across patient groups and can differentiate between acutely ill and subsequently treated patients. This test is able to quantify reduction in pulmonary infection and inflammation following treatment with greater accuracy than standard measurements such as FEV1 and CRP.


Potential Applications
Diagnostic test for measuring drug response in any lung related disease where inflammation, exacerbation or pulmonary infection is present


State of Development
The test has been validated in CF




Patent Status
Issued U.S. Patents #9,624,543 (Opens in a new window) (Opens in a new window), #8,101,361 (Opens in a new window) (Opens in a new window), and #8,465,923 (Opens in a new window) (Opens in a new window). Other US patents pending


Milene Saavedra, MD and Jerry Nick, MD


Licensing Status
This technology is available for licensing


For Further Information, Contact:
Emmanuel Hilaire, PhD
Technology Transfer Office
National Jewish Health
1400 Jackson St., Room M206b
Denver, CO 80206
Voice: 303.398.1262
Fax: 303.270.2352