To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

开始日期2022-04-29

申办/合作机构

VA Long Beach Healthcare System

[+2]

NCT04564781 / RecruitingN/AIIT

A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer

To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.

开始日期2020-09-18

申办/合作机构

Cedars-Sinai Medical Center

[+5]

NCT03193541 / RecruitingN/AIIT

A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

开始日期2016-12-30

申办/合作机构

Cedars-Sinai Medical Center

[+7]

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项与 Nonagen Bioscience Corp. 相关的文献（医药）

2024-05-17·Clinical Cancer Research

Abstract A006: Bladder cancer risk stratification with the Oncuria 10 plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms

作者: Hogrefe, Wayne ; Rosser, Charles ; Sakatani, Toru ; Tanaka, Sunao ; Murakami, Kaoru ; Furuya, Hideki ; Waldron, Richard

AbstractIntroduction and Objectives Oncuria® is a bead-based multiplex fluorescence immunoassay that coordinately measures 10 protein biomarkers in urine samples. The current study compared assay performance and output when urine samples were evaluated with the Oncuria assay using three different fluorescence-analyzing instruments commonly used in diagnostic laboratories worldwide. Methods We compared the performance of the clinically validated Oncuria bladder cancer (BC) multiplex immunoassay when data output was generated on three different analyzer systems. Voided urine samples from 36 subjects (18 with BC and 18 Controls) were reacted with Oncuria test reagents in three 96 well microtiter plates, and consecutively evaluated on the LED/image based MagPix, and laser/flow based Luminex 200 and FlexMap 3D (all xMAP instruments from Luminex Corp., Austin, TX). The BC assay uses magnetic bead based fluorescence technology (xMAP, Multi-analyte profiling; Luminex) to simultaneously quantify 10 protein analytes in urine specimens [i.e., angiogenin (ANG), apolipoprotein E (ApoE), carbonic anhydrase IX (CA9), CXCL8/interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), matrix metalloproteinase-10 (MMP-10), serpin A1/alpha-1 anti-trypsin (A1AT), serpin E1/plasminogen activator inhibitor-1 (PAI-1), CD138/syndecan-1 (SDC1), and vascular endothelial growth factor-A (VEGF-A)]. Results All three platforms categorized all 10 analytes in identical samples at nearly identical concentrations, with variance across systems typically <5%. While the most contemporary instrument, the FlexMap 3D, output higher raw fluorescence values than the two comparator systems, standard curve slopes and analyte concentrations determined in urine samples were concordant across all three units. Forty-four percent of BC samples registered ≥1 analyte above the highest standard concentration, i.e., A1AT (n=7/18), IL-8 (n=5), and/or ANG (n=2). In Controls, A1AT was higher in one sample. Conclusions In conclusion, the Oncuria BC assay performed similarly well across three different flow analysis platforms for all 10 analytes simultaneously evaluated in urine samples. This agreement across instruments indicates that the test is amenable to standardized performance in laboratories using existing xMAP, without requiring costly outlays for new equipment.Citation Format: Toru Sakatani, Sunao Tanaka, Kaoru Murakami, Richard Waldron, Wayne Hogrefe, Charles Rosser, Hideki Furuya. Bladder cancer risk stratification with the Oncuria 10 plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms [abstract]. In: Proceedings of the AACR Special Conference on Bladder Cancer: Transforming the Field; 2024 May 17-20; Charlotte, NC. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(10_Suppl):Abstract nr A006.

2024-05-17·Clinical Cancer Research

Abstract A002: Assessment of the diagnostic accuracy of Oncuria-Detect® for detection of upper tract urothelial carcinoma

作者: Linehan, Jennifer ; Lee, Riko ; Rosser, Charles ; Sakatani, Toru ; Murakami, Kaoru ; Tanaka, Sunao ; Furuya, Hideki ; Fujita, Kazutoshi ; Pagano, Ian

AbstractIntroduction and Objective: Due to insufficient accuracy, urine-based assays currently have a limited role in the management of patients with upper tract urothelial carcinoma (UTUC). The application of a robust urine-based multiplex assay, Oncuria-Detect®, to aid in the detection of UTUC has the potential to address this deficiency and to assist with accurate, non-invasive diagnosis. Methods: To evaluate the performance of Oncuria-Detect®, a multiplex immunoassay capable of querying a voided urine sample for 10 protein biomarkers associated with urothelial carcinoma (A1AT, APOE, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA). Its application to UTUC was evaluated in a multi-institutional cohort of 35 prospectively collected subjects presenting for evaluation of upper tract mass along with 46 prospective collected matched controls (i.e., non-tumor bearing). The ability of the test to identify patients harboring UTUC was assessed. UTCU status was confirmed by endoscopy and tissue biopsy or definitive surgery. Diagnostic performance was assessed using ROC curves. Results: Oncuria-Detect® provided an AUC of 0.886 (95% CI: 0.807-0.964) with an overall sensitivity of 91.4%, specificity of 73.9%, NPV 91.9% and PPV 72.7%. Sensitivity values of the diagnostic panel for low-grade UTUC, high-grade UTUC, non-invasive UTUC and invasive UTUC were 86.7%, 90.9%, 88.9% and 94.1%, respectively. Urinary cytology or selective ureteral washing/cytology was associated with an overall sensitivity of 54.2%, specificity of 100%, NPV 63.3% and PPV 100%. Sensitivity values of cytology for low-grade UTUC, high-grade UTUC, non-invasive UTUC and invasive UTUC were 100%, 100%, 100%, and 77.8%, respectively. Conclusions: Urinary levels of a biomarker panel enabled the accurate discrimination of UTUC and controls non-tumor bearing individuals. The multiplex Oncuria-Detect® test can achieve the efficient and accurate detection of UTUC in a non-invasive patient setting.Citation Format: Toru Sakatani, Sunao Tanaka, Kazutoshi Fujita, Jennifer Linehan, Kaoru Murakami, Riko Lee, Ian Pagano, Charles Rosser, Hideki Furuya. Assessment of the diagnostic accuracy of Oncuria-Detect® for detection of upper tract urothelial carcinoma [abstract]. In: Proceedings of the AACR Special Conference on Bladder Cancer: Transforming the Field; 2024 May 17-20; Charlotte, NC. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(10_Suppl):Abstract nr A002.

2024-03-22·Cancer Research

Abstract 3773: Bladder cancer risk stratification with the Oncuria 10 plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms

作者: Hogrefe, Wayne ; Tanaka, Sunao ; Rosser, Charles J. ; Morales, Walter ; Murakami, Kaoru ; Waldron, Richard T. ; Sakatani, Toru ; Furuya, Hideki

AbstractIntroduction and Objectives: Oncuria® is a bead-based multiplex fluorescence immunoassay that coordinately measures 10 protein biomarkers in urine samples. The current study compared assay performance and output when urine samples were evaluated with the Oncuria assay using three different fluorescence-analyzing instruments commonly used in diagnostic laboratories worldwide.Methods: We compared the performance of the clinically validated Oncuria bladder cancer (BC) multiplex immunoassay when data output was generated on three different analyzer systems. Voided urine samples from 36 subjects (18 with BC and 18 Controls) were reacted with Oncuria test reagents in three 96 well microtiter plates, and consecutively evaluated on the LED/image based MagPix, and laser/flow based Luminex 200 and FlexMap 3D (all xMAP instruments from Luminex Corp., Austin, TX). The BC assay uses magnetic bead based fluorescence technology (xMAP, Multi-analyte profiling; Luminex) to simultaneously quantify 10 protein analytes in urine specimens [i.e., angiogenin (ANG), apolipoprotein E (ApoE), carbonic anhydrase IX (CA9), CXCL8/interleukin-8 (IL-8), matrix metalloproteinase-9 (MMP-9), matrix metalloproteinase-10 (MMP-10), serpin A1/alpha-1 anti-trypsin (A1AT), serpin E1/plasminogen activator inhibitor-1 (PAI-1), CD138/syndecan-1 (SDC1), and vascular endothelial growth factor-A (VEGF-A)].Results: All three platforms categorized all 10 analytes in identical samples at nearly identical concentrations, with variance across systems typically <5%. While the most contemporary instrument, the FlexMap 3D, output higher raw fluorescence values than the two comparator systems, standard curve slopes and analyte concentrations determined in urine samples were concordant across all three units. Forty-four percent of BC samples registered ≥1 analyte above the highest standard concentration, i.e., A1AT (n=7/18), IL-8 (n=5), and/or ANG (n=2). In Controls, A1AT was higher in one sample.Conclusions: In conclusion, the Oncuria BC assay performed similarly well across three different flow analysis platforms for all 10 analytes simultaneously evaluated in urine samples. This agreement across instruments indicates that the test is amenable to standardized performance in laboratories using existing xMAP, without requiring costly outlays for new equipment.Citation Format: Sunao Tanaka, Toru Sakatani, Kaoru Murakami, Richard T. Waldron, Walter Morales, Wayne Hogrefe, Charles J. Rosser, Hideki Furuya. Bladder cancer risk stratification with the Oncuria 10 plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3773.

项与 Nonagen Bioscience Corp. 相关的新闻（医药）

2024-03-04

·BioSpace

DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024

PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024. Oncuria, a novel 10-biomarker urine test, is the first of its kind that has been developed as specific tests namely: Oncuria-Detect: Designed for the detection of bladder cancer, providing accurate and reliable results to aid in early diagnosis and treatment planning. Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance. Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies. Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, emphasized the significance of this achievement: "The approval of Oncuria® tests for reimbursement by CMS is a momentous milestone. With the superior performance of Oncuria in clinical studies we look forward to continuing wide adoption of the Oncuria tests." Dr. Charles Rosser, CEO of Nonagen Bioscience, expressed his enthusiasm for the recognition of these tests by payers: "It is great to see the clinical value of these tests being recognized by payers. CMS' coverage decision will enable more patients to benefit from the suite of Oncuria tests. I am especially excited for the expanded use of Oncuria Predict in helping to identify patients that may not respond to BCG treatment (BCG is a common first-line treatment for bladder cancer)." This approval underscores DiaCarta's commitment to advancing precision medicine and improving patient outcomes in bladder cancer care. By securing Medicare reimbursement for Oncuria®, DiaCarta continues to facilitate access to innovative diagnostic solutions for patients and healthcare providers nationwide. About DiaCarta: DiaCarta is a leading molecular diagnostics company dedicated to advancing precision medicine through innovative solutions. With a focus on improving patient outcomes across various oncology indications, DiaCarta's portfolio of cutting-edge assays empowers clinicians with actionable insights for personalized treatment strategies. For more information, visit . About Nonagen Bioscience Nonagen Bioscience is a biotechnology company focused on globally reducing the burden of cancer with innovative diagnostics. As a physician-led company, Nonagen Bioscience is committed to bringing to market the best-in-class, noninvasive diagnostics for cancer detection, therapy choice, and disease monitoring, so patients can live better, longer lives. The Los Angeles-based company was founded in 2011 and is currently developing diagnostics for bladder, breast, and prostate cancers. For more information, visit . Nonagen Contact: Investor Relations - investor@nonagen.com For media inquiries or further information, please contact: Anne Vallerga PhD, MBA VP, External Affairs 650-333-3152 373739@email4pr.com

2023-04-27

·BioSpace

Nonagen Bioscience announces Timothy "TJ" Johnson as Executive Chair of Nonagen Bioscience Corporation

LOS ANGELES, April 27, 2023 /PRNewswire/ -- Nonagen Bioscience, a cancer diagnostics company, today announced that Timothy "TJ" Johnson has been named Executive Chair of the Nonagen Bioscience Corporation. Mr. Johnson has nearly 30 years of executive leadership experience in the life sciences industry. Timothy "TJ" Johnson has been named Executive Chair of the Nonagen Bioscience Corporation. In his new role, Mr. Johnson will provide strategic and operational direction, collaborate with Nonagen's CEO and senior management on research and commercialization efforts, and advise on all company ventures and strategic partnerships. "We're thrilled to welcome TJ and his effective style of leadership," said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "Not only does he have an impressive track record of success in managing companies like ours, but he also shares our passion to bring science to bear in the fight against cancer." Mr. Johnson has held C-suite and executive-level leadership positions for several life sciences companies, including Ventana Medical Systems, Inc., a medical diagnostics company that was acquired by Roche in 2007. He spent more than 12 years as president and CEO and as a member of the board of directors at HTG Molecular Diagnostics, including leading a successful IPO in 2015. Previously, he had a career that spanned more than 10 years at Hillenbrand Industries, Inc. Mr. Johnson holds a bachelor's degree in business from Indiana University. "Nonagen Bioscience is breaking new ground in the field of cancer diagnostics with its Oncuria® liquid biopsy for the early detection and management of bladder cancer," said Mr. Johnson. "I look forward to working with this talented team to bring noninvasive diagnostic tests to healthcare providers and their patients." About Nonagen Bioscience Nonagen Bioscience is a privately held biotechnology company that is focused on globally reducing the burden of cancer with innovative diagnostics. The Los Angeles–based company is committed to bringing to the market best-in-class, noninvasive diagnostics for cancer detection, therapy choice, and disease monitoring, so patients can live better, longer lives. Nonagen's lead diagnostic for bladder cancer, Oncuria®, is available as a laboratory developed test through DiaCarta Laboratories in the United States and Canada. Nonagen Bioscience is currently seeking US Food and Drug Administration approval for Oncuria as an in vitro diagnostic test. Contacts MEDIA Jenny Sparano Vice President, Public Relations jsparano@peregrinemarketaccess.com INVESTOR RELATIONS Dave Mori Chief Business Officer mori@nonagen.com View original content to download multimedia: SOURCE Nonagen Bioscience

高管变更IPO并购

2023-04-06

·PRNewswire

Nona Biosciences Enters into Collaboration Agreement with ExeVir Bio

Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited, committed to cutting-edge technology innovation and provider of integrated solutions from "Idea to IND" (I to I™ ), announced today it has entered into a collaboration agreement with ExeVir Bio. The collaboration aims to accelerate the development of innovative therapeutics for unmet needs in infectious diseases, harnessing the combined expertise and resources of both companies. Jingsong Wang, MD, PhD, Chairman of Nona Biosciences, said, " By combining our respective expertise in antibody engineering and the disease area, we are confident that this collaboration will yield groundbreaking discoveries and bring us closer to eradicating the most challenging infectious diseases." Dr. Torsten Mummenbrauer, CEO of ExeVir, added, " The collaboration with Nona Biosciences will be an important support in our ongoing research on bringing new infectious diseases treatments to patients and will deliver additional options to ExeVir's pipeline in infectious diseases. About Nona Biosciences Nona Biosciences (a wholly-owned subsidiary of HBM Holdings, HKEX: 02142) is a global biotechnology company committed to cutting edge technology innovation, and providing a total solution from "Idea to IND" (I to I™ ), ranging from target validation and antibody discovery through preclinical research. The integrated antibody and antibody-related discovery services with multiple modalities range from antigen preparation, animal immunization, single B cell screening, to antibody lead generation and engineering, developability assessment and pharmacological evaluation, leveraging advantages of Harbour Mice® platforms and the experienced therapeutic antibody discovery team. Harbour Mice® generates fully human monoclonal antibodies in classical two light and two heavy chain (H2L2) format, and heavy chain only (HCAb) formats. Integrating Harbour Mice® and a single B cell cloning platform, Nona Biosciences is focused on driving global inventions of transformative next-generation drugs. For more information, please visit: www.nonabio.com About ExeVir Bio ExeVir Bio is a clinical stage biotechnology company developing single-domain antibody based therapeutics focusing on infectious diseases. The company is harnessing its llama-derived antibody (VHH) technology platform to generate multi-specific antibodies for prophylaxis and treatment of infectious diseases. ExeVir's initial focus is on prevention of COVID-19 for the immunocompromised patient population, including active chemotherapy, immunosuppressive drugs, solid organ transplantation, hematological malignancies, and AIDS patients, where there remains a high unmet need due to the limitations of current vaccines and therapeutic approaches. ExeVir's COVID-19 pipeline includes XVR012, a combination product of XVR013 and XVR014, a bi-specific single-domain-based antibody construct which targets two conserved epitopes in the S1 subunit. Together they target several S1 and S2 epitopes in one product. ExeVir is a spin out of VIB, the leading Belgium-based life sciences research institute. It is backed by strong investors including Fund+, which led the series A of EUR 42 million, together with an international consortium including UCB Ventures, FPIM, V-Bio Ventures, VIB, SRIW, Noshaq, Vives IUF and SambrInvest. ExeVir has received support from VLAIO, the SPW-Recherche and the European Union, leading to a total of €16.5M in non-dilutive funding. In 2023, Exivir secured an option for EUR 25 million venture debt financing from the European Investment Bank. SOURCE Nona Biosciences

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