Purified Enriched Population Exosomes Derived From Individuals With A Chronic Progressive Lung Disease For Noninvasive Detection, Staging, And Medical Monitoring Of Disease Progression

A method for noninvasively diagnosing and staging a progressive chronic lung disease characterized by disease related lung dysfunction comprising:

• (a) quantifying lung function of a subject with a progressive chronic lung disease characterized by disease-related lung dysfunction;
• (b) diagnosing and determining a stage of the chronic lung disease by:
• (i) collecting a biological sample from the subject with the lung disease and from a healthy control,
• (ii) centrifuging the biological sample at low speed to form a clarified supernatant;
• (iii) ultracentrifuging the clarified supernatant to pellet the purified enriched population of exosomes;
• and
• (iv) characterizing the purified enriched population of exosomes, wherein.
• (1) the population of exosomes expresses two or more exosome biomarkers selected from the group consisting of CD9, CD63, CD81, or HSP70;
• (2) size of the exosomes in the population of exosomes ranges from 30 m to 150 μm, inclusive;
• (3) the population of exosomes comprises a total protein of at least 100-200 μg, inclusive;
• (4) the population of exosomes comprise a total RNA content of at least 100-200 ng, inclusive;
• (5) number of exosomes in the population of exosomes comprises at least 10E10 particles;
• and
• (6) the population of exosomes comprises a cargo comprising dysregulated expression of two or more microRNAs selected from miR-199, miR Let-7a, miR Let-7b, mir-Let-7d, miR-10a, miR-21, miR-29a, miR-34, miR-101, miR-125, miR-145, miR-146a, miR-181a, miR-181b, miR-181c, miR-199, and miR-142,
• wherein expression of the two or more microRNAs, compared to a healthy control, comprises a signature of a fibrotic lung disease;
• and
• (c) medically managing the diagnosed fibrotic lung disease as early as possible in the course of progression of the disease to reduce or slow its progression by
• (1) treating the diagnosed fibrotic lung disease;
• and
• (2) monitoring over time the population of exosomes derived from the biological sample of the subject compared to a population of exosomes derived from a biological sample derived from a healthy control.