Nucleix News
21 articlesNucleix's Bladder EpiCheck® Receives FDA 510(k) Clearance for Monitoring of Non-Muscle Invasive Bladder Cancer (NMIBC) Recurrence
Nucleix to Premiere Data on its EpiCheck® Lung Cancer Atlas at the 2023 American Association for Cancer Research Annual Meeting
Nucleix Receives CAP Accreditation and CLIA Certification for its San Diego Clinical Laboratory
Nucleix Expands EU Label Indication of Bladder EpiCheck® to Include the Detection of Primary Bladder Cancer and Detection of Primary and Recurrent Upper Tract Urinary Cancer
Bladder EpiCheck® Included in 2022 European Association of Urology (EAU) Clinical Guidelines on Non-Muscle Invasive Bladder Cancer (NMIBC)
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Nucleix announces $22 million in funding, advancements in lung cancer detection program
Israeli company Nucleix has secured an additional $22 million in funding, bringing the total capital raised in 2021 to $77 million. The funding was led by Sands Capital, with additional investors including RA Capital, Zohar Zisapel, and OrbiMed. Nucleix develops non-invasive, DNA methylation-based cancer screening tests. The company also announced the appointment of Catherine Schnabel as its chief scientific officer. Nucleix has made advancements in its EpiCheck Next Generation Sequencing (NGS) platform and lung cancer detection program for early-stage disease. Their Lung EpiCheck blood test analyzes changes in methylation markers to screen for lung cancer in high-risk individuals based on smoking history.
InvestmentManagement Changes
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Liquid biopsy co Nucleix raises $55m
Nucleix, a liquid biopsy developer for the earlier detection of cancer, has completed a $55 million financing round. The investment will be used to speed up the development of its methylation technology and its lead product, Lung EpiCheck, for the early detection of lung cancer. Nucleix plans to demonstrate the power of the technology through a focused program in lung cancer, advancing tests that are highly sensitive, easily deployed, and cost-effective. The company expects EpiCheck to be on the market in 2022. The financing round was led by RA Capital Management and included participation from new investors BlackRock, Lilly Asia Ventures, LYFE Capital, and MILFAM, as well as existing investors.
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Nucleix's BE Safe @Home Project Brings Bladder Cancer Surveillance to Patients' Homes During COVID-19 Pandemic and Beyond
Nucleix's Lung EpiCheck® Liquid Biopsy Test Detects 85% of Early Stage Lung Cancers in High-Risk Smokers, Study Published in European Respiratory Journal BioSpace
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Data supports accuracy and performance of Nucleix's Bladder Epicheck in NMIBC surveillance
An independent analysis of studies of Nucleix Ltd.’s Bladder Epicheck demonstrate high diagnostic accuracy and performance in monitoring for disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC).
Customers
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Flask Real Time Analytics Help Flaskdata Customer Detect Early Stage Lung Cancer With Blood Test
Flaskdata.io, a SaaS company, is being used by a customer in the detection of early stage lung cancer. The company specializes in helping life sciences companies complete their clinical trials faster. Nucleix Ltd. is one of the successful companies that have used Flaskdata.ios services. Flaskdata.io provides a SaaS platform for clinical trial management and offers various products such as Flask Forms and Flask API. The company aims to further modern life sciences and assist in developing new tests. They collaborate with partners to develop business globally.
Customers
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Israel's Nucleix Targeting US Market With Noninvasive Bladder, Lung Cancer Assays
Israeli liquid biopsy startup Nucleix plans to enter the US cancer detection market with diagnostic assays for early-stage cancers. The company aims to launch a lung cancer diagnostic assay next year and is building a CLIA-certified, CAP-accredited lab in the US. Nucleix recently completed a clinical trial for its Bladder EpiCheck cancer diagnostic assay and plans to submit it to the FDA for clearance. The companys EpiCheck technology searches for methylation patterns on circulating tumor DNA in a patients liquid sample. Nucleix is also developing an early-stage lung cancer diagnostic test called Lung EpiCheck. The company has raised $33 million in funding, including investments from Orbimed, Aurum, Zohar Zisapel, DSC, and OCI.
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https://www.jpost.com/Jpost-Tech/Business-and-Innovation/New-non-invasive-bladder-cancer-test-transforms-invasive-follow-up-process-581357
Nucleix, a cancer diagnostic company, has developed the Bladder EpiCheck, a urine test for monitoring bladder cancer. The test has received European CE approval and has become the standard of care in a leading Netherlands hospital. It is currently undergoing clinical trials in the US for submission to the FDA. The Bladder EpiCheck is a noninvasive tool that detects bladder cancer recurrence with high accuracy, reducing the need for invasive procedures like cystoscopies. The test has a negative predictive value of over 99%. Nucleix is also developing Lung EpiCheck, a blood test for the early detection of lung cancer. The company has received €2.5 million in funding for its development.
CustomersPartners
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Israeli cancer detection co Nucleix wins €2.5m EU grant
Israeli cancer detection and screening company Nucleix has received €2.5 million in funding for Lung EpiCheck, a screening diagnostic blood test for early detection of lung cancer. The funding comes from the EIC pilot SME Instrument Phase II European program, which is part of Horizon 2020. Nucleix plans to use the funding to accelerate the development of Lung EpiCheck and begin extensive clinical trials in Europe and the US in the beginning of next year.
Investment
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Nucleix Announces Publication of Non-Invasive Bladder Cancer Recurrence Detection Study Showing Best-in-Class Performance
Nucleix Ltd., a cancer detection and screening company, announced the publication of a European study on its Bladder EpiCheck urine test for the detection of bladder cancer recurrence. The study demonstrated the high performance of Bladder EpiCheck and its potential to reduce invasive procedures. The test showed a high negative predictive value (NPV) and sensitivity, making it a valuable tool for clinical decision making. Bladder EpiCheck is a CE approved urine test that has been clinically validated in leading hospitals and labs in Europe. The company is also developing additional assays for the detection of other types of cancers. The market penetration of Bladder EpiCheck looks promising, with several leading hospitals and labs in Europe already using the test.
Customers
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Nucleix Announces its Bladder EpiCheck™ Availability on the QIAGEN Rotor-Gene Q Platform
Nucleix, a cancer detection and screening company, announced the compatibility of its Bladder EpiCheck with the Rotor-Gene Q real-time PCR platform. This widens the available market for Bladder EpiCheck, allowing more laboratories to offer the companys assays. The Rotor-Gene Q platform is widely placed in the target customer segments of pathology and molecular diagnostics. Nucleixs first product, Bladder EpiCheck, is a urine test for monitoring the recurrence of bladder cancer. The companys pipeline includes a screening diagnostic blood test for early lung cancer detection. Nucleix is backed by OrbiMed and other leading investors.
CustomersPartners
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Bladder cancer monitor gets CE Mark;lung cancer test next
Nucleix has received CE Mark approval to market Bladder EpiCheck in the European Union. The noninvasive urine test helps urologists monitor bladder-cancer patients. The approval follows a clinical study of 400 patients, and the results were presented at a urology meeting. Nucleixs next product in the pipeline is Lung EpiCheck for detecting lung cancer in blood samples.
Customers
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CE Mark Granted to Nucleix's Bladder EpiCheck - Announcing Superior Results Over All Other Non-Invasive Tests in a European Multi-Center Study for Bladder Cancer Monitoring
Nucleix, an innovative cancer detection and screening company, has received regulatory approval for marketing its Bladder EpiCheck test in the European Union countries. The test aims to help urologists better monitor bladder cancer patients. The regulatory approval follows a successful clinical study that showed the Bladder EpiChecks high performance in comparison to the current gold standard follow-up sequence. Nucleixs CEO expressed pride in the approval and study results, stating that they are important milestones for bladder cancer patients and urologists. The company plans to launch the product in Europe during the annual meeting of the European Association of Urology.
Customers
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A new noninvasive monitoring test for bladder cancer
Israeli company Nucleix has developed a simple and inexpensive urine test to monitor bladder cancer. The test, called Bladder EpiCheck, is currently undergoing advanced clinical trials in several European countries and is expected to be available in Europe in the third quarter of 2016. Nucleix plans to earn the CE mark this summer and then start clinical trials in the US and apply for FDA approval. The company recently raised $3 million in a fundraising round led by Aurum Ventures MKI and existing shareholder Zohar Zisapel. The funds will be used for clinical trials, expanding the workforce, and marketing Bladder EpiCheck. Bladder cancer is the fifth most common cancer in the world and the fourth most common cancer among men.
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Israeli cancer detection co Nucleix raises $3m
Israeli cancer detection company Nucleix has raised $3 million in funding and is developing a method to detect different types of cancers using epigenetics. Their first test for bladder cancer detection could be available in Europe within a couple of months.
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Cancer screening co Nucleix raises $5m
Nucleix, a company developing a test for early detection of bladder cancer, has raised over $5 million in an investment round led by OrbiMed Advisors LLC. The company had previously raised $3 million from private investors. Nucleix uses epigenetics to identify cancer cells before symptoms appear, and has discovered fifteen indicators that can distinguish cancerous cells from healthy ones. The product could potentially be used for testing other types of cancer as well. The investment round included participation from Orbimed Israel and Zohar Zisapel.
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