Methods of diagnosing and treating cervical cancer
Inventors
Checa Rojas, Alberto • Santillan Godinez, Orlando • Dominguez Palestino, Raúl
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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-11771740-B2
Publication Date
2023-10-03
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 biomarker-based methods for non-invasive diagnosis, staging, prognosis, prediction of treatment response, monitoring, and treatment-decision for cervical cancer and cervical lesions by detecting altered expression of specified polypeptides in subject samples. The polypeptides include neurofibromin I, glyceraldehyde-3-phosphate dehydrogenase, eukaryotic initiation factor 4A-I, nuclear heterogeneous ribonucleoprotein A1, glutathione S-transferase Mu 3, and panel members such as Farnesyl pyrophosphate synthase and Ankyrin-3. Samples include blood, serum, plasma, urine, saliva, vaginal fluid, and biopsy, and detection formats include LC/MS, protein microarray, ELISA, immunoassays, microfluidics, and lateral or vertical flow assays.
The specification provides SEQ ID NOs 1–20 and broader panels up to SEQ ID NOs 1–147, with variants of approximately seventy percent or greater identity and defined fragments, to support assay design and validation. A lateral-flow kit comprising a sample collection unit and a lateral flow device is disclosed, with experimental validation and prototype workflow described [procedural detail omitted for safety]. Detection informs diagnosis, prediction, monitoring, staging, and administration of treatments selected from surgery, radiation, chemotherapy, targeted therapy, and immunotherapy.
Claims Coverage
The patent includes one independent claim that recites two main inventive features.
Detecting altered expression of specified polypeptides in a subject sample
Detecting altered expression of at least one polypeptide in a sample from a subject; wherein the at least one polypeptide comprises neurofibromin I, glyceraldehyde-3-phosphate dehydrogenase, eukaryotic initiation factor 4A-I, nuclear heterogeneous ribonucleoprotein A1, and glutathione S-transferase Mu 3.
Diagnosing, predicting, or monitoring cervical cancer 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.
The independent claim covers detecting altered expression of specified polypeptides in a subject sample and performing one or more of diagnosing, predicting, or monitoring cervical cancer or a cervical lesion based on that detection.
Stated Advantages
Non-invasive early detection and diagnosis of cervical cancer and precancerous lesions.
Staging and prognosis for cervical cancer and precancerous lesions.
Monitoring of cervical cancer status.
Predicting treatment response to guide treatment-decision.
Facilitates treatment-decision and administration of surgery, radiation, chemotherapy, targeted therapy, or immunotherapy.
Provision of a kit with sample collection and a lateral flow device to enable point-of-care testing.
Use of multiple accessible sample types including blood, serum, plasma, urine, saliva and vaginal fluid.
Documented Applications
Diagnosing, predicting, and/or monitoring the status or outcome of cervical cancer or a cervical lesion by detecting altered expression of specified polypeptides in a subject sample.
Staging and prognosis of cervical cancer based on altered polypeptide expression.
Predicting treatment response and guiding administration of treatments selected from surgery, radiation, chemotherapy, targeted therapy, and immunotherapy.
Non-invasive detection using biological samples including blood, serum, plasma, urine, saliva, vaginal fluid, biopsy material, and CSF.
Detection using platforms including LC/MS, protein microarray, ELISA, immunoassays, microfluidic devices, and lateral or vertical flow assays.
Use of a lateral flow kit comprising a sample collection unit and a lateral flow device.
Provision of primary sequence targets and SEQ ID references for assay design and validation.
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