IP Library Granted Patent US 11,913,957
Granted Patent B2
US 11,913,957 · App. 15/786,924 · Granted Feb 27, 2024

Compositions, methods and kits for diagnosis of lung cancer

Inventors: Paul E. Kearney (Seattle, WA); Kenneth C. Fang (San Francisco, CA); Xiao-Jun Li (Bellevue, WA); Clive Hayward (Seattle, WA); Douglas Spicer (Enumclaw, WA)
Assignee: Biodesix, Inc.
G01N33/57423G01N33/6893G01N33/53G01N33/6848G16B20/00G16B40/00
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Quick Facts
Patent No.
US 11,913,957
App. No.
15/786,924
Granted
Feb 27, 2024
Kind
B2
Abstract

Methods are provided for identifying biomarker proteins that exhibit differential expression in subjects with a first lung condition versus healthy subjects or subjects with a second lung condition. Also provided are compositions comprising these biomarker proteins and methods of using these biomarker proteins or panels thereof to diagnose, classify, and monitor various lung conditions. The methods and compositions provided herein may be used to diagnose or classify a subject as having lung cancer or a non-cancerous condition, and to distinguish between different types of cancer (e.g., malignant versus benign, SCLC versus NSCLC).

Claims (15)

1. A method of treating a pulmonary nodule in a subject, comprising:

(a) performing an immunoassay to measure expression levels of a panel of proteins present in a blood sample of the subject, wherein the panel comprises LG3BP and C163A;

(b) determining a probability of lung cancer score based on the measurements of step (a); and

(c) treating the subject having a score in step (b) that is equal to or greater than a predetermined score by surgery, chemotherapy, radiotherapy, or any combination thereof.

2. The method of claim 1 , wherein the immunoassay is enzymelinked immunosorbent assay (ELISA).

3. The method of claim 1 , wherein the panel of proteins further comprises at least one of ALDOA, FRIL, TSP1, COIA1, PEDF, MASP1, GELS, LUM, PTPRJ, IBP3, LRP1, ISLR, GRP78, TETN, PRDX1, CD14, BGH3, FIBA, and GSLG1.

4. The method of claim 1 , wherein the pulmonary nodule of the subject has a diameter of less than or equal to 3 cm.

5. The method of claim 1 , wherein the pulmonary nodule of the subject has a diameter of about 0.8 cm to 3.0 cm.

6. The method of claim 1 , wherein the subject is at risk of developing lung cancer.

7. The method of claim 1 , wherein the subject is 40 years or older.

8. The method of claim 1 , further comprising a clinical assessment.

9. The method of claim 8 , wherein clinical assessment comprises a procedure selected from a PFT, pulmonary imaging, a biopsy, a surgery, and any combination thereof.

10. The method of claim 9 , wherein the pulmonary imaging is an x-ray, a chest computed tomography (CT) scan, or a positron emission tomography (PET) scan.

11. The method of claim 1 , wherein the panel of proteins consisting essentially of, or consisting of LG3BP and C163A.

12. The method of claim 1 , wherein the step (a) comprises contacting the blood sample with a LG3BP antibody and a C163A antibody.

Assignments (5)
SECURITY AGREEMENT Recorded Nov 22, 2022
From: BIODESIX, INC.
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 061977/0919 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 29, 2020
From: HAYWARD, CLIVE
To: INTEGRATED DIAGNOSTICS, INC.
Reel/Frame 053346/0056 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 29, 2020
From: KEARNEY, PAUL E.; SPICER, DOUGLAS
To: INTEGRATED DIAGNOSTICS, INC.
Reel/Frame 053346/0457 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 29, 2020
From: KEARNEY, PAUL E.; FANG, KENNETH C.; LI, XIAO-JUN; HAYWARD, CLIVE
To: INTEGRATED DIAGNOSTICS, INC.
Reel/Frame 053352/0201 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2018
From: INTEGRATED DIAGNOSTICS, INC.
To: BIODESIX, INC.
Reel/Frame 046416/0688 →
Continuity (8)
Continuation In Part 15051153 · Feb 23, 2016
Continuation 13775494 · Feb 25, 2013
Continuation In Part 13724823 · Dec 21, 2012
Provisional Application 61725153 · Nov 12, 2012
Provisional Application 61676859 · Jul 27, 2012
Provisional Application 61589920 · Jan 24, 2012
Provisional Application 61578712 · Dec 21, 2011
Related Publication 20180067119A1 · Mar 8, 2018
Cited By (1)
US 12,247,980