Menarini Silicon Biosystems's CELLSEARCH® CMMC and HER2-CTC Liquid Biopsy Tests obtain Reimbursement Codes with Preliminary Pricing Determination

These new codes are required to access Medicare/Medicaid insurance reimbursement for novel CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) and HER2 Circulating Tumor Cell (CTC-HER2) assays,to monitor disease status in patients with life-threatening illnesses.

HUNTINGDON VALLEY,Pa.,Oct. 13,2022 -- 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.

As part of the annual pricing process for CPT codes in the Medicare Clinical Laboratory Fee Schedule (CLFS),CMS recently issued a preliminary determination to price both CPT PLA codes on a 'gapfill' basis. Gapfilling occurs when no comparable,existing test is available and thereby recognizes the added value of MSB's two assays. This gapfill process enables Medicare contractors to recommend CLFS pricing for each new CPT code in a vote to CMS the following year based on actual cost data provided by the testing laboratory/manufacturer instead of previously established payment rates. Final CLFS pricing for the CPT PLA codes would thus go into effect in January 2024. Further details on the CLFS pricing process are available on the CMS website1.

The new CPT PLA codes include:

CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) assay – 0337U

CELLSEARCH HER2 Circulating Tumor Cell (CTC-HER2) assay – 0338U

Both of these assays are laboratory developed tests (LDTs) regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations provided out of Menarini Silicon Biosystems' clinical lab in Huntingdon Valley,PA.

The CELLSEARCH CMMC assay is intended for clinical use in patients with plasma cell disorders such as multiple myeloma (MM),the second most common blood cancer,as well as precursor conditions including monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM). By capturing and enumerating CMMCs from peripheral blood,this assay has the potential to reduce invasive,often painful,and costly bone marrow (BM) biopsies to monitor MM disease progression and status in real-time.

The CELLSEARCH HER2 Circulating Tumor Cell (CTC-HER2) assay is intended to reduce the need for impractical or contraindicated tissue biopsy in patients with EpCAM (Epithelial Cell Adhesion Molecule)-expressing tumors that often overexpress the human epidermal growth factor receptor (HER) 2 biomarker. The HER family of receptors plays a central role in the pathogenesis of several human cancers and the introduction of HER2 directed therapies has the potential to dramatically influence the outcome of patients with HER2 positive breast and gastric/gastroesophageal cancers,making accurate testing for HER2 all the more critical.

According to Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems(MSB) Inc,"we are excited to be a step closer to making these tests more affordable and accessible for an increasing number of cancer patients who otherwise would not have the opportunity to benefit from the crucial clinical information and convenience of a minimally invasive liquid biopsy test. We are working hard to bring these innovative solutions to both healthcare providers and patients,knowing the considerable impact they can have on improving patient outcomes."

CELLSEARCH CMMC and CELLSEARCH CTC-HER2 test results are available within 3 working days and allow treating physicians to timely access information for precision care.

About Menarini Silicon Biosystems Inc

MSB offers unique rare cell technologies and solutions that provide clinicians and clinical researchers with access to unparalleled data on rare cells and their molecular characterization.

In the US,MSB's Pennsylvania-based lab is CAP/CLIA accredited,and ISO 15189-accredited for CELLSEARCH®. The MSB laboratory-developed tests (LDTs) are used to detect and analyze CTCs in human blood. The minimally invasive approach,on which they are based,allows them to contribute significantly to optimizing patient care and comfort throughout the patient's therapeutic journey.

MSB Inc,based in Huntingdon Valley,PA.,U.S.,is a wholly owned subsidiary of the Menarini Group,a multinational pharmaceutical,biotechnology and diagnostics company headquartered in Florence,Italy,with more than 17,000 employees in 140 countries.

Footnotes/disclaimers

Menarini Silicon Biosystems,Inc. is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform clinical testing.

These assays are laboratory developed tests (LDTs) regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations provided out of Menarini Silicon Biosystems' clinical lab in Huntingdon Valley,PA. They should not be regarded as investigational or for research use only.

The performance characteristics,safety and effectiveness of these tests have not been established and are not cleared or approved by the FDA.

CPT Copyright 2017 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

1 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings

Media Contact: Linda PAVY – linda.pavy@bcw-global.com