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Composition and method for detecting malignant neoplastic disease

A composition and complex technology, applied in chemical instruments and methods, disease diagnosis, biomaterial analysis, etc., can solve the problems of lack of organ specificity, elevated serum levels, etc.

Active Publication Date: 2016-10-26
FUJIREBIO DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Recommended for routine use as tumor markers, these markers have limited clinical utility due to their lack of organ specificity and elevated serum levels in non-malignant disease

Method used

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  • Composition and method for detecting malignant neoplastic disease
  • Composition and method for detecting malignant neoplastic disease
  • Composition and method for detecting malignant neoplastic disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0381] Assay for the Determination of Heterocomplexes of Keratin 7 and Keratin 19 in Body Fluids

[0382] The aim is to generate an assay suitable for clinical evaluation.

[0383] According to the method described in "Recent development in the periodate method of conjugating horseradish peroxidase (HRP) to antibodies" (M Barbara Wilson and Paul K. Nakane, Elsevier / North-Holland Biomedical Press, 1978), the keratin 7-specific The monoclonal antibody Ks 7.18 was conjugated to biotin and the monoclonal antibody BM 19.21 specific for keratin 19 was conjugated to peroxidase.

[0384] A sandwich enzyme-immunoassay was performed to determine the heterocomplexity of keratin 7 with keratin 19 in body fluids obtained from patients diagnosed with a malignant neoplastic disease or from patients diagnosed with a non-malignant disease or individuals considered healthy substance or fragments thereof. In this procedure, two monoclonal antibodies (biotin-conjugated Ks 7.18 (1 μg / ml) and per...

Embodiment 2

[0386] Sensitivity of the K7 / K19 assay for different forms of cancer

[0387] A total of 398 sera from patients with various forms of cancer were tested using the K7 / 19 assay described in Example 1. The results are summarized in Table 1.

[0388] In conclusion, the K7 / K19 assay showed the highest clinical sensitivity for bladder, ovarian, lung, and esophageal cancers compared to other cancers studied, and especially samples from lung, bladder, and ovarian cancer patients had high concentrations of keratin Heterocomplex of 7 with keratin 19 (or a fragment thereof). In contrast, the K7 / K19 assay showed sensitivities as low as 10% or less for squamous cell and breast cancers of the cervix, as well as head and neck and gastrointestinal cancers. The concentration values ​​of the heterocomplex of keratin 7 and keratin 19 (or fragments thereof) of these latter cancer patients were in the same range as those of the controls (healthy and benign) in Table 2. K7 / K19 assays are therefo...

Embodiment 3

[0392] Establishment of reference ranges for healthy individuals.

[0393] One hundred and twelve (112) sera from apparently healthy individuals were tested according to the K7 / K19 assay as described in Example 1 in order to establish a reference range for individuals with no overt signs of malignant neoplastic disease. 95% of the individuals had a concentration of the heterocomplex of keratin 7 and keratin 19 or fragments thereof of less than 1.01 U / mL, or 95.5% had a value of 1.09 U / mL or less. Five (5) of 112 healthy individuals (ie 4.5%) had concentrations above 1.1 U / mL. The average concentration of the heterocomplex of keratin 7 and keratin 19 or fragments thereof in the test individuals was 0.15 U / mL (see Table 2).

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Abstract

The present invention provides a composition comprising at least two targeting agents, wherein at least one first targeting agent recognizes a keratin 7 peptide and / or fragment(s) thereof, and at least one second targeting agent recognizes a keratin 19 peptide and / or fragment(s) thereof. Said first and second targeting agents are capable of binding specifically and simultaneously to a heterotypic complex of keratin 7 with keratin 19, and / or fragment(s) thereof. The composition of the invention may be used in methods for diagnosing and / or prognosing, predicting efficacy of treatment, assessing outcome of treatment of assessing recurrence of malignant neoplastic disease, such as e.g. lung cancer, bladder cancer, esophagus cancer, and ovarian cancer in a subject.

Description

technical field [0001] The present invention relates to the field of malignant neoplastic diseases. In particular, it relates to compositions and methods for improved detection of malignant neoplastic diseases and their diagnostic and / or prognostic uses. Background of the invention [0002] There is a great need for simple, accurate and cost-effective methods that can aid in the diagnosis of malignant diseases to aid in treatment decision-making and management of patients. Currently available tumor markers (with a few exceptions) have been reduced to therapy monitoring due to lack of sensitivity and specificity. Essentially all tumor markers are unsatisfactory as a single marker and new and more specific markers are required to complement established ones. In particular, lack of tumor specificity, ie increased marker values ​​in various tissues in various benign conditions such as liver cirrhosis, renal failure and general inflammation, is a fundamental problem with curren...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/18G01N33/569
CPCC07K16/18G01N2333/4742G01N2800/52G01N33/57488G01N33/577G01N2800/50G01N33/574C07K2317/32
Inventor A·奥尔维克O·雷文
Owner FUJIREBIO DIAGNOSTICS