COMPANY:

Menarini

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."

"Menarini Silicon Biosystems...announced today the launch of a new assay to meet the needs of pharma companies, CROs, clinicians and research scientists working on multiple myeloma (MM). This new CELLSEARCH® Circulating Multiple Myeloma Cells (CMMCs) Assay* captures and enumerates CMMCs from peripheral blood. It has the potential to reduce invasive, often painful, and costly bone marrow (BM) biopsies to monitor in real-time MM evolution and study disease biology. Its availability across Europe and the US will allow for increased data consistency during international multicenter MM trials."