Methods of detecting bladder cancer
Inventors
Higuchi, Russell • Wallace, Stacey Ellen • Lai, Edwin Wei-Lung
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Assignees
Member
CepheidCepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Cepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Publication Number
US-12410483-B2
Publication Date
2025-09-09
Expiration Date
Abstract
Compositions and methods for detecting bladder cancer are provided. In some embodiments, methods of monitoring recurrence of bladder cancer are provided. In some embodiments, the methods comprise detecting a set of markers consisting of CRH, IGF2, KRT20, and ANXA10.
Core Innovation
Compositions and methods for detecting bladder cancer are provided, including bladder cancer markers and panels of markers useful in the detection of bladder cancer. In some embodiments, the methods comprise detecting a set of markers consisting of corticotrophin releasing hormone (CRH), insulin-like growth factor 2 (IGF2), keratin 20 (KRT20), and annexin 10 (ANXA10).
The patent addresses the need for improved, non-invasive diagnostic tests for bladder cancer given that long-term follow up commonly relies on cystoscopy and urine cytology, which are described as invasive, costly and labor-intensive. In some embodiments, levels of CRH, IGF2, KRT20 and ANXA10 mRNA are measured [procedural detail omitted for safety], and the results can be used to determine whether or not a subject has bladder cancer or to monitor subjects with a history of bladder cancer for tumor recurrence.
Claims Coverage
The claims include one independent claim directed to a method for detecting bladder cancer markers; the coverage focuses on detection of a four-marker set and producing/detecting corresponding amplicons.
Detecting a four-marker bladder cancer panel in urine or bladder washing samples
Detecting the levels of each bladder cancer marker amplicon of a set of bladder cancer markers in a urine sample or bladder washing sample, wherein the set consists of CRH, IGF2, KRT20 and ANXA10, by contacting RNA from the sample with a set of primers, conducting one or more polymerase chain reactions [procedural detail omitted for safety], and detecting a set of bladder cancer marker amplicons that is produced by the PCR.
The independent claim is centered on detecting amplicons corresponding to the four-marker set (CRH, IGF2, KRT20, ANXA10) in urine or bladder washing samples by primer-driven amplification and detection of the resulting amplicons.
Stated Advantages
Does not rely on cytology, potentially reducing dependence on labor-intensive and subjective cytology assays.
A four-marker signature (CRH, IGF2, KRT20, ANXA10) can provide equivalent or better sensitivity and/or specificity compared to larger signatures and existing diagnostic assays.
Can be carried out in a single reaction mixture using detectably different dyes, enabling a one-pot reaction.
Can be completed in under three hours, and in some embodiments under two hours.
Can be carried out on much smaller volumes of urine (in some embodiments, 5 ml or less).
Can be carried out in a substantially automated manner and, in some instances, at the point of care using an automated system such as GeneXpert®.
Documented Applications
Detecting the presence of bladder cancer in a subject by measuring levels of the four-marker set in a urine sample or bladder washing sample.
Monitoring subjects with a history of bladder cancer for tumor recurrence using measurements of CRH, IGF2, KRT20 and ANXA10 mRNA.
Detecting bladder cancer in subjects with no history of bladder cancer, including subjects who have symptoms of bladder cancer.
Use of an endogenous control (for example, ABL, GUSB, GAPDH, TUBB, UPK1) and/or an exogenous control RNA to normalize or verify assay performance.
Assessing effectiveness of a treatment for bladder cancer by comparing target RNA levels at various times during treatment to archival samples.
Routine screening of individuals, including screening asymptomatic individuals having risk factors for bladder cancer.
Performing the assay in a single multiplex reaction to detect the set of bladder cancer markers, and providing compositions or kits comprising primer pairs and probes for the four markers.
Implementing the methods on an automated platform, exemplified by use with the GeneXpert® system.
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