COMPANY:

Nucleix

"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."

"Nucleix...announced data from two abstracts featuring its Bladder EpiCheck® test at the 36th Annual European Association of Urology (EAU) Virtual Congress....The first abstract titled, 'Real world evidence of alternating cystoscopy/cytology with Bladder EpiCheck in NMIBC surveillance,'....In the pilot analysis, patients with follow-up showed Bladder EpiCheck achieved 100% sensitivity for high-grade disease, with specificity of 88%, thereby avoiding 76% of unnecessary cystoscopies....The second abstract titled, 'DNA methylation urine biomarkers test (EpiCheck® assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study,'...The study found that Bladder EpiCheck achieved a high-grade sensitivity of 95.8%; a high-grade negative predictive value of 97.2%; and a specificity of 80.6% in urine collected from the ureter-bladder junction, compared to 80.0%, 90.0% and 91.7% for cytology, respectively."

"Nucleix...today announced the publication of an analysis highlighting that Bladder EpiCheck® can reduce both patient burden and healthcare system costs in the U.S. and European countries for low grade intermediate risk non-muscle invasive bladder cancer (NMIBC)...Authors attributed the cost-effectiveness of this alternative strategy to Bladder EpiCheck’s high specificity of 86%. This is because lower specificity often results in patients receiving additional cystoscopies, ultimately leading to higher overall costs to the healthcare system. Importantly, for such an alternating schedule to be clinically acceptable, high sensitivity for high-grade disease is key to ensure patients with a high-grade recurrence, who are at risk of disease progression, are detected promptly and treated."

"Nucleix...has entered into a collaborative research and license agreement with The University of Texas MD Anderson Cancer Center to evaluate and develop methylation assays focused on lung cancer, using Nucleix's highly sensitive EpiCheck platform....The collaboration will focus initially on evaluating methylation markers believed to be important for the characterization of lung cancer subtypes. 'Blood-based methylation assays are minimally invasive and have the potential to provide key information about a patient's lung cancer that cannot be provided by standard genomic profiling of DNA mutations, helping physicians to better identify disease subtypes and emerging biomarkers in the clinic,' said John V. Heymach, M.D...."

"Nucleix...has secured $55 million from a syndicate of leading life science investors in an oversubscribed financing round...Nucleix will utilize the proceeds of the financing to continue the rapid advancement of its unique methylation technology, known as EpiCheck®, and to develop Lung EpiCheck®, its lead product for the early detection of lung cancer."

"Nucleix…announced the launch of its BE Safe @Home project to bring surveillance for recurrence of non-muscle invasive bladder cancer (NMIBC) to patients’ homes with its Bladder EpiCheck® urine test. This initiative was developed after consulting with world-leading urologists in an effort to make surveillance more convenient for patients during COVID-19 and beyond. The project is implemented in Israel, Spain and the Netherlands."

"Nucleix…today announced a publication showing its Lung EpiCheck® test detected 85% of early stage lung cancers among individuals at high risk for developing the disease based on their history of smoking. The study, entitled ‘Validation of Lung EpiCheck®, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals,’ was published online today ahead of print in the European Respiratory Journal (ERJ)."