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COMPANY:
Nucleix

i
Other names: Nucleix | Nucleix Ltd. | Nucleix, Ltd.
Related tests:
Evidence

News

11d
Nucleix Demonstrates Potential of its PCR EpiCheck Assay to Accurately Differentiate Between Small Cell Lung Cancer (SCLC) Subtypes (Businesswire)
"Nucleix...today announced data from a pilot study demonstrating the potential of a simple PCR assay based on EpiCheck technology to accurately differentiate between small cell lung cancer (SCLC) subtypes. The Company is presenting the data in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, April 5-10....In the data being presented at AACR, the 13-marker PCR assay correctly classified 97% of the SCLC tissue samples in a blinded cohort."
Clinical data
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Lung EpiCheck®
5ms
Nucleix Receives Reimbursement for Bladder EpiCheck in the Netherlands (Businesswire)
"Nucleix...announced it has been informed it will receive national reimbursement approval from The Dutch Healthcare Authority (NZA) in the Netherlands, effective January 1, 2024, for its CE-marked Bladder EpiCheck® test for detection of primary or recurrent bladder cancer and upper tract urinary cancer."
Reimbursement
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Bladder EpiCheck®
6ms
Nucleix Bladder EpiCheck® now available in France via the Association Francaise d'Urologie (AFU) Registry for surveillance of recurrence of bladder cancer (Businesswire)
"Nucleix...announced participation in the Association Francaise d'Urologie (AFU) Registry of the Therapeutic Management and Follow-Up of Non-Muscle-Invasive Bladder Cancer (TVNIM-AFU). The registry will evaluate the diagnostic performance of selected urine biomarkers in French patients and compare them to the results of bladder endoscopies (cystoscopy) performed over two years for routine follow-up of NMIBC. The registry is open to all urologists who are members of the AFU to include patients undergoing tumor resection."
Clinical
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Bladder EpiCheck®
6ms
Nucleix advances early lung cancer detection program with promising performance data and appointment of Chief Scientific Officer (Businesswire)
"Nucleix...announced recent updates in its lung cancer detection program for early-stage disease...At the American College of Chest Physicians (CHEST) 2023 Annual Meeting...presented initial performance data from the Sightline study, a prospective multi-center, case-control study evaluating the performance of Lung EpiCheck®."
Clinical data
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Lung EpiCheck®
7ms
Nucleix Announces Upcoming Presentation of Performance Data from Sightline Study of Lung EpiCheck at the American College of Chest Physicians (CHEST) 2023 Annual Meeting (Businesswire)
"Nucleix...announced that new data from the Sightline study of Lung EpiCheck® will be presented by Dr. Peter Mazzone from Cleveland Clinic in a late-breaking rapid-fire original investigations session during the American College of Chest Physicians (CHEST) 2023 Annual Meeting, October 8-11 in Honolulu. The presentation will showcase initial performance data from the Sightline study, a prospective multi-center, case-control study evaluating the performance of Lung EpiCheck, a non-invasive test to aid in the detection of early-stage lung cancer in high-risk patients."
Observational data
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Lung EpiCheck®
12ms
Nucleix’s Bladder EpiCheck Receives FDA 510(k) Clearance for Monitoring of Non-Muscle Invasive Bladder Cancer (NMIBC) Recurrence (Businesswire)
"Nucleix...has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Bladder EpiCheck® for use as a non-invasive method for surveillance of tumor recurrence in patients previously diagnosed with non-muscle invasive bladder cancer (NMIBC), in conjunction with cystoscopy....Bladder EpiCheck is a highly sensitive and specific test that analyzes subtle disease-specific changes across 15 methylation markers that are associated with bladder cancer. The test is commercially available in Europe and is the first of its kind methylation-based urine test performed on a qPCR platform to be cleared by the FDA....Nucleix is evaluating strategic partnerships and other market access activities for the commercial launch of Bladder EpiCheck in the United States."
FDA event
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Bladder EpiCheck®
1year
Nucleix to Premiere Data on its EpiCheck Lung Cancer Atlas at the 2023 American Association for Cancer Research Annual Meeting (Businesswire)
"Presentations will highlight company’s multiomic, genome-wide discovery platform with methylation at its core, to identify blood-based biomarkers focused on early-stage lung cancer detection...Nucleix...will premiere data from its early lung cancer detection discovery platform, the Nucleix EpiCheck® Lung Atlas, at the American Association for Cancer Research (AACR) Annual Event in Orlando, April 14-19. The proprietary Lung Atlas was constructed and developed as part of a multi-institutional effort to map epigenetic and genomic changes associated with early-stage lung cancer, particularly stage I disease."
Clinical data
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Lung EpiCheck®
over1year
Nucleix receives CAP accreditation and CLIA certification for its San Diego clinical laboratory (Businesswire)
"Nucleix...announced that their San Diego-based clinical laboratory received accreditation by the College of American Pathologists (CAP). This achievement follows the recent certification under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services."
Regulatory
almost2years
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 (Businesswire)
"Nucleix...announced that the company has expanded the European Union (EU) label indication of its Bladder EpiCheck® test. Bladder EpiCheck detects DNA methylation patterns in urine that are associated with urothelial cancer....The current update expands the label indication to also include aiding in the detection of primary bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, and the detection of recurrent UTUC, in conjunction with standard diagnostic procedures."
European regulatory
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Bladder EpiCheck®
2years
Bladder EpiCheck Included in 2022 European Association of Urology (EAU) Clinical Guidelines on Non-Muscle Invasive Bladder Cancer (NMIBC) (Businesswire)
"Nucleix...announced its Bladder EpiCheck® test has been included in the 2022 European Association of Urology (EAU) Clinical Guidelines for non-muscle invasive bladder cancer (NMIBC)...The EAU guidelines state that urinary biomarker tests with high sensitivity and negative predictive values for high-grade disease, including a specific reference to Bladder EpiCheck, might be used to replace and/or postpone cystoscopies in low- and intermediate-risk NMIBC, and reduce the number of cystoscopies in this patient population."
Clinical guideline
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Bladder EpiCheck®
over2years
Nucleix raises additional $22M (Precision Medicine Online)
"Israeli cancer diagnostics developer Nucleix...raised $22 million in December, extending a financing round closed earlier last year...Nucleix is developing liquid biopsy tests for early-stage and recurring cancer diagnosis that use PCR and next-generation sequencing technologies to detect tissue-specific methylation patterns on circulating tumor DNA that can be analyzed using proprietary software."
Financing
over2years
Nucleix announces recent advancements in early lung cancer detection program (Businesswire)
"Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, announced recent advances in its EpiCheck® Next Generation Sequencing (NGS) platform and lung cancer detection program for early stage disease...While EpiCheck revealed many promising markers that are indicative of early-stage disease, the bisulfite approach only identified 1% of what EpiCheck detected. This result strengthens our belief that the EpiCheck technology sees biology that other approaches miss."
Clinical
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Lung EpiCheck®