Methods of diagnosing cervical cancer based on altered polypeptide expression and treatment thereof
Inventors
Checa Rojas, Alberto • Santillan Godinez, Orlando • Dominguez Palestino, Raul
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Assignees
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-12433933-B2
Publication Date
2025-10-07
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 panel of protein biomarkers comprising Farnesyl pyrophosphate synthase (FDPS), Neurofibromin 1 (NF1), GAPDH, FNDC1, EIF4A1, LDHB, HNRNPA1, PKD1L1, HSPA8, ANK3, ARHGAP23, KRT78, COL6A3, PSMB5, HNRNPA2B1, H2B type 1-B, DNAJC13, ENO3, GSTP1 and GSTM3 for non-invasive diagnosis, staging, treatment decisioning and monitoring of cervical cancer. Detection of altered expression in subject samples [procedural detail omitted for safety], and variants with ≥~70% sequence identity to SEQ ID NOs are contemplated.
The invention provides amino acid sequences and sequence variants (SEQ ID NOs including canonical and variant sequences) for the enumerated polypeptides to support detecting altered expression and diagnosing cervical cancer or cervical lesions. The method comprises detecting altered expression of at least one polypeptide from the expressly listed panel, diagnosing based on that detection, and optionally administering surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
The disclosure includes secretome identification and serum detection evidence for FPPS and ANK3, and development of a lateral flow assay and kit embodiments [procedural detail omitted for safety]. These data support diagnosing, staging, predicting treatment response, and monitoring cervical cancer by measuring altered expression of the defined biomarkers in biological samples.
Claims Coverage
The independent claims collectively recite up to three main inventive features.
Detecting altered expression of specified polypeptides
Detecting altered expression of at least one polypeptide in a sample from a subject; wherein the at least one polypeptide comprises protein 1 containing fibronectin domain type III, L-lactate dehydrogenase chain B, 1-like protein 1 polycystic kidney disease, heat shock protein cognate 71 kDa, rho 23 GTPase-activating protein, cytoskeletal keratin 78 type II, alpha-3 collagen chain (VI), beta subunit of proteasome type-5, heterogeneous nuclear ribonucleoproteins A2/B1, histone H2B type 1-B, homolog of DnaJ subfamily c member 13, beta enolase and glutathione S-transferase P.
Diagnosing, predicting, or monitoring based on detected altered expression
One or more of diagnosing, predicting, or monitoring cervical cancer or a cervical lesion based on the detection of the altered expression of the at least one polypeptide, thereby diagnosing, predicting, and/or monitoring the status or outcome of cervical cancer.
Administering a cervical cancer or cervical lesion treatment
Administering a cervical cancer or cervical lesion treatment to the subject, wherein the treatment is selected from the group consisting of surgery, radiation, chemotherapy, targeted therapy and immunotherapy.
The independent claims cover detecting altered expression of one or more expressly enumerated polypeptides in a subject sample, using that detection to diagnose, predict, or monitor cervical cancer or a cervical lesion, and, in certain embodiments, administering a treatment selected from surgery, radiation, chemotherapy, targeted therapy or immunotherapy.
Stated Advantages
Non-invasive diagnostics
Accessible diagnostics
Multiplex-capable diagnostics
Suitable for early detection, staging, prognosis, and treatment monitoring of cervical cancer
Supports selection and administration of appropriate treatment for cervical cancer based on biomarker expression
Provides multiple detection modalities [procedural detail omitted for safety]
Validates biomarkers (including FPPS and Ankyrin-3) in tumor-bearing mice and in human cervical cancer and precancerous patient sera, supporting clinical utility.
Documented Applications
Diagnosing cervical cancer or a cervical lesion based on detection of altered expression of at least one polypeptide.
Staging cervical cancer.
Predicting treatment response and providing prognosis.
Monitoring cervical cancer and precancerous lesions.
Guiding treatment selection and administering treatments including surgery, radiation, chemotherapy, targeted therapy and immunotherapy following diagnosis based on altered polypeptide expression.
Use of a lateral-flow diagnostic kit comprising a sample collection unit and a lateral flow device with instructions [procedural detail omitted for safety].
Detection of biomarkers in various sample types [procedural detail omitted for safety].
Enabling design of detection reagents and confirming the molecular identities of the claimed polypeptides.
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