Pulmolisa is intended to be used as an aid by physicians for the differential diagnosis of suspected cases of lung cancer.
How does the test work?
Pulmolisa is a multiplex ELISA that uniquely detects protein epitopes in the blood plasma that suggest the presence of lung cancer.
It is the result of 15 years of development1 and is patent protected2
In total, almost 1600 subjects participated in two independent clinical trials during the discovery and clinical validation and regulatory approval phases. To learn more about the clinical trials click here. (link to technology page)
Pulmolisa combined with LDCT significantly improves specificity over the use of LDCT alone.
When combined with LDCT (low-dose pulmonary CT), Pulomolisa has a calculated sensitivity of 92.9% (7% false negative) and specificity of 87.1% (13% false positive)
The use of Pulmolisa combined with LDCT can potentially reduce the number of LDCT examinations by up to 50% in the long term. More importantly for patients, it has the potential to equally reduce the number of unecessary biopsies by up to 50%, sparing patients from unecessary risk.
For whom is the test intended?
- Patients with symptoms of lung cancer for whom LDCT imaging shows ambiguous nodule(s).
- Patients with symptoms of lung cancer whose condition does not allow diagnostic bronchoscopy or biopsy due to their age or other health condition.
What are the results and how are they intepreted ?
Based on the results of the blood test, the samples are classified into “high”, “medium”, and “low lung cancer risk” categories according to two thresholds.
- Low risk:
“Low lung cancer risk” samples, with a score below threshold 1, define the group of patients who have a minimal or zero risk of lung cancer at the time of the study. Depending on the circumstances, it is recommended to repeat the test after 12 to 24 months, supplemented by an LDCT test, depending on the test result.
- Medium risk:
Between the two thresholds, the risk of lung cancer is “medium”. Depending on the circumstances, it is recommended to repeat the test after 3 to 12 months. In this category, we define several risk subgroups based on test values, medical history, smoking habits, carcinogenic exposure, age, and family cancer data.
- High risk:
“High lung cancer risk” samples, with a score above threshold 2, define the group of patients who have a very high risk of lung cancer at the time of the test. Immediate histological biopsy is recommended for LDCT nodules > 7 mm and repeat testing after 3 to 6 months is recommended for nodules < 7 mm.
How to order a test
The test is performed in our own laboratory from a blood sample taken from the patient during routine blood testing.
Blood samples require specific preparation/treatment so please consult with us first.
The results of the blood test are delivered to the ordering doctor within 1-2 weeks.