Methods of diagnosing and treating cervical cancer or a high-grade cervical lesion based on expression of ankyrin-3
Inventors
Checa Rojas, Alberto • Santillan Godinez, Orlando • Dominguez Palestino, Raul
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Assignees
Atso Corporate Affairs SA de CV • Timser SAPI De CV
Member
TIMSER S.A.P.I. de C.V.TIMSER S.A.P.I. de C.V. is a biomedical company in Mexico developing accessible and non-invasive blood-based screening solutions for early detection of cervical cancer and its precursor lesions. The company leverages more than a decade of research to advance clinically validated molecular diagnostics using protein biomarkers identified through proteomics and molecular biology approaches. These technologies address barriers to traditional screening and are backed by extensive national and international patent coverage and clinical trial validation involving hundreds of participants.
TIMSER S.A.P.I. de C.V. is a biomedical company in Mexico developing accessible and non-invasive blood-based screening solutions for early detection of cervical cancer and its precursor lesions. The company leverages more than a decade of research to advance clinically validated molecular diagnostics using protein biomarkers identified through proteomics and molecular biology approaches. These technologies address barriers to traditional screening and are backed by extensive national and international patent coverage and clinical trial validation involving hundreds of participants.
Publication Number
US-11160845-B2
Publication Date
2021-11-02
Expiration Date
Abstract
The present invention is related to diagnostic tests or rapid detections of different types of cancer, especially cervical cancer and precancerous lesions. Especially, the invention relates to specific and useful protein biomarkers for the detection of said diseases, and to the methods for determination and detection of said biomarkers.
Core Innovation
The invention provides a method that detects increased expression of Ankyrin-3 in a sample from a subject, performs a biopsy to diagnose cervical cancer or a high-grade cervical lesion, and administers a treatment selected from a defined group of agents. The method ties a biomarker measurement to diagnostic confirmation by biopsy and to selection of specified chemotherapeutic, targeted, or immunotherapeutic agents for treatment of cervical cancer and high-grade cervical lesions.
The disclosure also describes a diagnostic and treatment-guidance platform based on a panel of secreted protein biomarkers, including Ankyrin-3 and Farnesyl pyrophosphate synthase among approximately twenty proteins. Acceptable biological samples include blood, serum, plasma, urine, saliva, cerebrospinal fluid, biopsy, and vaginal fluid. A lateral flow diagnostic kit comprising a sample collection unit, a device, and instructions facilitates testing.
The specification provides extensive amino-acid sequence listings and variant-specific information that supply molecular identifiers to enable design of detection reagents and assays for Ankyrin-3 expression and to support detection and quantification. The disclosure addresses the need to link an Ankyrin-3 biomarker with diagnostic confirmation and therapy selection, and supports staging, prognosis, prediction and monitoring of treatment response, and informing treatment decisions.
Claims Coverage
The patent includes one independent claim that sets forth three main inventive features.
Detecting increased expression of Ankyrin-3
Detecting increased expression of Ankyrin-3 in a sample from a subject.
Performing a biopsy to diagnose cervical cancer or a high-grade cervical lesion
Performing a biopsy to diagnose cervical cancer or a high-grade cervical lesion.
Administering a selected treatment from a specified group
Administering a treatment to the subject; wherein the treatment is selected from the group consisting of cisplatin, carboplatin, paclitaxel, topotecan, docetaxel, ifosfamide, 5-fluorouracil, irinotecan, gemcitabine, mitomycin, bevacizumab and pembrolizumab.
The independent claim ties detection of increased Ankyrin-3 expression to biopsy-based diagnosis of cervical cancer or a high-grade lesion and to administration of a defined list of chemotherapeutic, targeted, and immunotherapeutic agents.
Stated Advantages
Enables non-invasive diagnosis of cervical cancer and high-grade cervical lesions.
Supports staging, prognosis, prediction and monitoring of treatment response, and informing treatment decisions.
Provides molecular identifiers and sequence data enabling design of detection reagents, nucleic-acid probes, antibodies, and diagnostic assays for Ankyrin-3, supporting detection and quantification.
Supports use of Ankyrin-3 expression as a biomarker for diagnosing cervical cancer or high-grade cervical lesions and guiding treatment selection.
Provides a lateral flow diagnostic kit comprising a sample collection unit, a device, and instructions to facilitate testing.
Documented Applications
Detecting increased Ankyrin-3 expression in a sample from a subject.
Diagnosing cervical cancer or a high-grade cervical lesion via biopsy following detection of increased Ankyrin-3 expression.
Guiding selection and administration of treatments selected from cisplatin, carboplatin, paclitaxel, topotecan, docetaxel, ifosfamide, 5-fluorouracil, irinotecan, gemcitabine, mitomycin, bevacizumab and pembrolizumab.
Staging and prognosis of cervical disease.
Predicting and monitoring treatment response.
Guiding treatment selection, including surgery, radiation, chemotherapy, targeted therapy, and immunotherapy.
Design of detection reagents and diagnostic assays for Ankyrin-3 expression based on provided sequence listings.
Use of multi-protein diagnostic panels, including Ankyrin-3 and other listed biomarker proteins, for diagnosing cervical cancer.
Use of biological sample types including blood, plasma, urine, saliva, cerebrospinal fluid, biopsy and vaginal fluid in diagnostic testing.
Use in a lateral flow diagnostic kit comprising a sample collection unit and a device.
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