COMPANY:

Menarini

"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."

P3 | N=800 | NCT01710605 | "...the STIC CTC trial demonstrates that the use of CTC count as a tool for choosing between endocrine therapy (ET) and chemotherapy (CT) is non-inferior to the investigator's choice in terms of short and long-term clinical outcomes. While approximately 60% of the study participants had a concordant indication between the clinical risk-guided arm and the CTC-guided treatment arm, in the subgroup of patients with a discordant estimate, the use of frontline CT in the CTC-guided treatment arm instead of ET yielded a clinically and statistically significant gain of 16.4 months in median overall survival (OS)."

P3 | N= 105 | DETECT III (NCT01619111) | "A total of 2,137 patients with HER2 negative MBC were screened for HER2 positive CTCs using Menarini Silicon Biosystems' CELLSEARCH^® CTC System and the CELLSEARCH HER2 tumor phenotyping reagent. 105 patients, with at least one detected HER2 positive CTC in the initial CTC screening phase, were randomized to either lapatinib in combination with standard therapy or to standard therapy alone. Patients in the lapatinib arm had a significantly improved OS with a median survival time of 20.5 months compared to a median survival time of 9.1 months for patients in the standard arm (HR 0.54; 95% CI 0.34–0.86; p = 0.008)...the results indicate that CTC-guided treatment allocation may help optimize treatment strategies and should therefore be further investigated. The study also confirmed the prognostic role of CELLSEARCH CTC enumeration."

"The study was submitted under the new Clinical Trial Regulation, and it is expected to start the activation process in the fourth quarter of 2023....Twelve countries have been selected to participate in the trial (Italy, France, Belgium, Spain, Ireland, Cyprus, Germany, Greece, the Netherlands, Portugal, Sweden and Switzerland) with more than 120 sites expected to screen approximately 1960 patients. The randomised, open label, superiority phase III trial will evaluate whether elacestrant can delay the occurrence of metastasis or death compared to standard adjuvant endocrine therapy in patients with early-stage ER+/HER2- breast cancer and molecular relapse."

P=NA| N=325 | "Menarini Silicon Biosystems, a pioneer of liquid biopsy technology, announced today the publication, in the peer-reviewed journal Cancers, of the results of a clinical study on the utility of CTCs to detect disease relapse substantially earlier than what is currently possible with routine surveillance imaging, in patients with stage III melanoma....Moreover, patients, who had zero CTCs in their blood, were significantly less likely to develop disease relapse compared to those who had a presence of at least 1 CTC (HR: 0.37, 95% CI: 0.26–0.53, p-value < 0.001)."

"Menarini Silicon Biosystems...announced today the availability of its new CELLSEARCH CTC lab service to detect expression of the Delta-Like Ligand 3 (DLL3) protein in tumor cells circulating in the bloodstream. This biomarker is mainly expressed in difficult-to-treat cancers....In addition, the new CELLSEARCH CTC test that detects this biomarker has the great advantage of being minimally invasive, standardized and allows for the dynamic real-time quantification of CTCs. It is based on the CELLSEARCH CTC platform, first and only clinically validated, FDA-cleared system for identification, isolation, and enumeration of CTCs in patients with metastatic breast, castration-resistant prostate or colorectal cancer."

"Menarini Silicon Biosystems...announced today its partnership with Alivio Health. This new agreement opens the door to preferred access for Alivio Health clients and providers to the valuable information offered by the CELLSEARCH CTC tests, which allow longitudinal monitoring of cancer patients at any time during the course of the disease....The new partnership will benefit the members of Alivio Health whose main mission is to facilitate access to the right test at the right time."

"Menarini Silicon Biosystems...announced...the data from two posters to be presented at the April 14-19, 2023 annual meeting of the American Association for Cancer Research (AACR). Among them, one demonstrated the benefit of an AI algorithm for automated, reliable, and reproducible CELLSEARCH® CTC identification, while the other focused on the additional information available through the parallel immunomagnetic enrichment of tumor derived extracellular vesicles and CTCs from a single blood sample."

P3 | N=800 | NCT01710605 | "Menarini Silicon Biosystems...announced the promising long-term results of the STIC trial, on OS (overall survival) in patients with ER+/HER2- MBC....'we were particularly impressed by the subgroup of patients with a low clinical risk profile and CTC count ≥ 5, for whom physicians, in line with guidelines, selected endocrine therapy (ET). When treated with chemotherapy (ChT) instead, these patients had a superior median OS of 16 months.' The trial further showed that, when escalated to ChT, these patients also experienced a 47% reduction in their risk of death."

P=NA | N=261 | "Menarini Silicon Biosystems...announced today the results of a study in which enumeration and genomic characterization of CTCs at varying stages of MM represents an invaluable tool to predict disease aggressiveness and pathology....Findings from this novel and robust proof-of-concept study were based on CTCs from 261 patients (84 MGUS, 155 SMM and 22 MM). The majority of precursor patients analyzed in the study showed evidence of CTCs, with one or more CTCs detected in 82% of the overall enrolled population-. In addition, the data showed an increase in the number of CTCs from MGUS to SMM, confirming the correlation between a higher disease burden and greater trafficking of CTCs. The Kaplan Meier analysis over a median follow-up time of 27 months, showed that SMM patients with CTCs (≥ 1 per 4mL of blood) had a higher probability of progression to MM (P=0.03)."

"Menarini Silicon Biosystems (MSB), Inc. is announcing that the AMA has issued Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) codes for two of its CELLSEARCH advanced liquid biopsy tests which received preliminary pricing determination by the US Centers for Medicare and Medicaid Services (CMS). Issuing of these codes represents a decisive step towards gaining broad access to Medicare/Medicaid reimbursement. This opens the door to affordable, less burdensome, minimally invasive liquid biopsy tests to improve the monitoring, and management of patients with challenging hematological and solid tumor types."

"Menarini Silicon Biosystems...announced today its new FFPE Rescue Application, to enable molecular testing on formalin-fixed, paraffin-embedded (FFPE) samples with low tumor cell contents...the sorting capabilities of the recently launched DEPArray PLUS instrument, it is possible to isolate a sufficient number of tumor cells to generate relevant molecular data, even from FFPE tissues that were previously discarded from conventional Next Generation Sequencing (NGS) processing."

"Results showed that CMMCs were detected in 27% of MGUS patients and in 57% SMM patients. Enumeration of CMMCs illustrated a correlation with the clinical measure of disease including the International Myeloma Working Group 2/20/20 risk stratification model. CMMCs can capture 100% of clinically annotated Bone Marrow FISH copy number variant [CNV] events. Furthermore, CMMC samples identified additional CNVs that were not observed by FISH."

"Menarini Silicon Biosystems...announced today the commercial launch of its CELLSEARCH® Laboratory Developed Test (LDT) for enumeration of CMMCs from whole blood. This commercial, CLIA-validated assay meets the certification standards of The Centers for Medicare and Medicaid Services. MSB's new LDT provides community physicians with an opportunity to identify at-risk patients and gain early information on disease progression."