numares AG Achieves Key Milestone: Identifies Candidate Metabolomic Network for Bladder Cancer Diagnostics
numares AG obtained promising results from a retrospective study that provides initial evidence that evaluation of metabolomic biomarker networks can be used as a non-invasive diagnostic for bladder cancer. Based on these results, the company enrolled patients in a prospective study to confirm and further refine the metabolomic network. The test is intended to be launched as a CE-marked in-vitro diagnostics (IVD) in Europe in the second half of 2018.
Bladder cancer can be challenging to diagnose. Available urine-based tests are often not reliable if there are traces of blood in the urine sample (called microhematuria), which is also associated with bladder cancer. However, even persistent microhematuria is a poor prognostic indicator, because only two to five percent of patients with microhematuria are diagnosed with bladder cancer. As a result, the majority of patients presenting with microhematuria undergo cystoscopy to rule out bladder cancer as a cause of the symptom. Cystoscopy is an invasive procedure that causes risks as well as pain for the patient. Thus, there is a significant need for a non-invasive bladder cancer screening test to reduce the number of cystoscopies.
To address this need, numares initiated a project to develop a non-invasive bladder cancer IVD test that would be run on AXINON ® , a fully-integrated laboratory system based on nuclear magnetic resonance (NMR) spectroscopy. The first step in the project was to evaluate approximately 300 urine samples from patients with and without bladder cancer with the objective of identifying metabolites that could be developed into a bladder cancer-specific metabolomic network.
“Based on this analysis, we have initiated and are currently finishing the recruitment phase of our prospective validation study, BLADE (Bladder Cancer Detection using Metabolomic Evaluation of Urine and Blood), to confirm our initial findings,” said Dr. Philipp Pagel, chief medical officer of numares. “We collected urine samples from patients with persistent microhematuria who are scheduled for cystoscopy. With this program, numares pursues the European Association of Urology’s (EAU) appeal to evaluate new biomarkers in urine for avoiding cystoscopies.”
“The positive results of our retrospective analysis were an important milestone for numares as the bladder cancer test has now advanced into the next phase,” said Volker Pfahlert, chairman of the executive board of numares. “When launched, the bladder cancer test will be our second metabolomic network-based diagnostic. The first, the recently-launched renalTX-SCORE®, uses a metabolomic biomarker network to diagnose kidney transplant rejection in urine samples. Along with renalTX-SCORE, the bladder cancer project further illustrates the power of the metabolomic biomarker network approach.”
About bladder cancer
Urinary bladder carcinoma is among the most common types of cancer with approximately 350,000 new cases per year. Men are significantly more often (3.8 times) affected than women. In Europe about 118,000 new cases were discovered in 2012. In the US there is an estimation of 80,000 new cases and 17,000 deaths by bladder cancer in 2017.
Bladder cancer is mostly associated with quite unspecific signs and symptoms, such as blood in the urine. If medical anamnesis and ultrasonic examination do not reveal the cause of the hematuria, as a next step a cystoscopy is recommended.
About biomarker networks
The innovative approach to use biomarker networks for diagnostic purposes becomes increasingly relevant for several further medical questions, which cannot be addressed by appropriate diagnostic solutions so far. It is numares’ mission to fulfill those unmet diagnostic needs by developing products for its NMR-based AXINON® IVD system. It is reflected by the company’s product pipeline. To achieve its mission, numares developed its proprietary Magnetic Group Signaling® (MGS®) technology as a prerequisite and employs machine learning techniques (also known as artificial intelligence) to process the large amount of data and to identify metabolomic biomarker networks.
About Magnetic Group Signaling
Nuclear Magnetic Resonance (NMR) has long been used as a research tool, in particular for determining the structure of chemical compounds. In the past, this technology was too complex to be used in metabolomics-based medical research or diagnostics due to several technical limitations. numares developed its proprietary Magnetic Group Signaling® (MGS®) technology to enable NMR to answer demanding questions in metabolomics. With MGS®, important prerequisites like standardization and qualification can be fulfilled through technical processes and procedures. For the first time systematic processing and use of diagnostic information from the metabolism is possible. Thanks to MGS®, numares’ in vitro diagnostic system (IVD) AXINON® is able to generate reliable and reproducible data of highest quality – independent of the NMR device or the user. This enables fully automated analysis of patient samples without any human intervention.
numares AG is a fast-growing innovative diagnostics company that develops and markets software-based test systems for high-throughput use in clinical diagnostics and life science research. The AXINON® IVD system and its diagnostic tests employ nuclear magnetic resonance (NMR) spectroscopy creating a “numaric” spectrum with which to evaluate metabolomic networks. The output of these analyses provide physicians with valuable information on the disease status of patients. numares developed its proprietary Magnetic Group Signaling® (MGS®) technology to enable NMR for highly standardized and rapid throughput testing, making it a cost-efficient new solution for diagnostic purposes. The metabolomics tests address unmet medical needs in the indication fields of cardiovascular diseases, nephrology, oncology and neurology, shaping another important pillar in precision medicine. numares AG is headquartered in Regensburg, Germany, with offices in Boston and Singapore.
You will find more information at http://www.numares.com.
Dipl.-Biol. Christiane Proll, MBA
+49 941 2809 49-14
IRA WÜLFING KOMMUNIKATION GmbH
Dr. Reinhard Saller
Tel.: +49 89 2000 30-30
The Ruth Group
Robert Flamm, Ph.D.
Kirsten Thomas/Cari Randall
E-Mail: email@example.com /firstname.lastname@example.org
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Smiths Detection Hold Baggage Scanner Meets Highest Security Standards in EU23.3.2018 10:00 | Tiedote
The Smiths Detection HI-SCAN 10080 XCT has achieved ECAC approval as a Standard 3.1 explosives detection system for hold baggage – the highest, defined security standard in the EU. This significant advance was made possible by using a dual-view, dual-energy line scanner with high resolution 3D Computed Tomography (CT) to deliver exceptional data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005050/en/ Smiths Detection HI-SCAN 10080 XCT (Graphic: Business Wire) This achievement gives airports currently upgrading to Standard 3 technology, the option to increase detection levels even further to 3.1; and any standard 3 systems already installed can be easily elevated to 3.1 via a software upgrade. The detection algorithms are interchangeable on a bag by bag basis depending on the destination and associated risk level. This offers additional flexibility and productivity. “With the capability to meet detection requirements
Sofinnova Partners Leads SafeHeal’s €6 Million Series a Financing Round23.3.2018 10:00 | Tiedote
SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners. Based in Paris, SafeHeal develops an innovative digestive anastomosis protection device, called Colovac, designed to reduce complications and obviate the need for ostomies for colectomy patients. This technology consists of a minimally invasive and fully reversible implant that remains in place until the body’s natural healing and tissue repair processes are complete, for approximately two weeks, after which it is removed. SafeHeal’s device has the potential to radically transform the market while significantly improve patients’ quality of life by enabling them to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. About 270,000 colectomy patients receive an ostomy every year in Europe and the USA, repre
Elliott Advisors (UK) Limited Statement on Telecom Italia23.3.2018 10:00 | Tiedote
Given the momentum behind Elliott's campaign at Telecom Italia to improve both performance and governance, Elliott was not surprised to see yesterday's resignation of seven board members affiliated with Vivendi. Unable to advance any meritorious arguments, the Board has simply abandoned their posts to stall for time. Elliott regards this action as cynical and self-serving, in that it delays the ability of Telecom Italia shareholders to express their votes at the upcoming AGM. This is yet another example of minority shareholder rights at Telecom Italia being abrogated and the continued disregard of corporate governance best practice. Finally, Vivendi should note Elliott's forty-year track record of consistent value creation, and sustained, long-term commitments to expose poor governance and catalyse positive change; Elliott's investment history in Telecom Italia dates back to 1999, well before Vivendi became a shareholder in the Company. About Elliott Elliott Management Corporation mana
Ipsen Receives Positive CHMP Opinion for Cabometyx® (cabozantinib) for the First-Line Treatment of Adults with Intermediate- or Poor- Risk Advanced Renal Cell Carcinoma23.3.2018 09:00 | Tiedote
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx® (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC).The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Alexandre Lebeaut, Executive Vice President, R&D and Chief Scientific Officer said: “Today’s positive opinion from the CHMP is important news for patients with previously untreated advanced renal cell carcinoma, who can shortly benefit from Cabometyx ® as a new first-line treatment option. Following the evidence of its clinical value after a prior VEGF-targeted treatment, we are pleased to be able to expand the benefit of Cabometyx ® for treatment-naïve patients wit
Swiss Wearable Brand MyKronoz Breaks Worldwide Records with its Hybrid Smartwatch ZeTime, on the Sidelines of a Challenging Baselworld 201822.3.2018 19:32 | Tiedote
On the sidelines of a downsized Baselworld 2018, MyKronoz, the premier watchmaking brand of the smart generation today announces record-breaking crowdfunding results of its hybrid smartwatch ZeTime, with more than $8,000,000 raised in less than a year. The international success of its unique and groundbreaking flagship wearable is followed by the release of a new digital video campaign “I’m a watch; I’m a smartwatch”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180322005963/en/ MyKronoz ZeTime Petite & Regular top $8M in crowdfunding (Photo: Business Wire) After a historic 35-days Kickstarter campaign launched in March 2017, ZeTime has pursued, since then, its crowdfunding journey on a variety of international and local platforms: Indiegogo, Makuake in Japan, Zec Zec in Taïwan, Wadiz in Korea and on the leading chinese e-commerce website JD.com. Further to this online momentum, MyKronoz has successfully shipped to over 10
Redwood Software Announces First Industry Robotic Licensing Model to Revolutionize Transparent Marketplace Pricing22.3.2018 17:59 | Tiedote
Redwood Software, the pioneer behind ‘The Robotic Enterprise’, today announced the launch of a revolutionary new robotic licensing model, where customers only pay for the robotic services they consume within their business. Available now, this new licensing model allows customers to directly compare the costs of manual work against processes that are robotized. With the unique Robotic Service Charge, Redwood only charges for the delivery of a robotic service, equivalent to a unit of work that can done by a person (send an email, download a report, reconcile two reports etc.). Redwood delivers a catalogue of 35,000 of these ready built robotic services that can be linked together by business users in a visual plug and play interface. End-to-end business processes can be modelled, robotized, tested and deployed without cost and risk. Only when the robotic service is consumed is a charge made, always replacing work that would otherwise be done manually. Within the Robotic Service Charge,
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme