COMPANY:

Nucleix

"In 316 patients undergoing surveillance from July 2023 until August 2024, 38 cancers were detected, of which 29 were high-grade and 13 were carcinoma in situ (CIS), an aggressive form of bladder cancer often missed by white light cystoscopy, that can progress to muscle-invasive cancer if left untreated. White light cystoscopy detected 17 (59%) of the high-grade cases and 4 (31%) of the CIS cases versus 28 (97%) and 12 (92%), respectively, detected by Bladder EpiCheck and confirmed by photodynamic diagnosis (PDD) biopsies. Specificity was 97% (261/270) for cystoscopy and 94% (253/270) for Bladder EpiCheck. Additionally, Bladder EpiCheck was able to detect 65% more high-grade disease recurrences compared to white light cystoscopy (28 vs. 17), by performing biopsy under PDD in patients with a negative white light cystoscopy and a positive Bladder EpiCheck result. Nine of the 16 (56%) patients that were missed by white light cystoscopy but detected with Bladder EpiCheck and PDD had CIS."

"A. Menarini Diagnostics...announced at the 36th European Congress of Pathology in Florence, that they have entered into a long-term commercial agreement for the exclusive distribution of the Bladder EpiCheck test in Europe. This non-invasive CE-marked test detects primary or recurrent bladder cancer and upper tract urinary cancer."

"Nucleix...announced that the results from the company's North American pivotal clinical study evaluating the performance of Bladder EpiCheck® as a non-invasive and objective novel methylation-based PCR urine test for the surveillance of non-muscle invasive bladder cancer (NMIBC) recurrence were presented in a podium presentation at the American Urological Association (AUA) Annual Meeting 2024 in San Antonio, Texas. The data presented demonstrated Bladder EpiCheck’s potential to improve timely disease recurrence detection and compliance with NMIBC surveillance."

"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."

"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."

"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."

"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®."

"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."

"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."

"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."

"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."

"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."

"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."

"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."

"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."