PR98262

HUNTINGDON VALLEY, Pa., Oct. 13, 2022 /PRNewswire=KYODO JBN/ --

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.

Menarini Silicon Biosystems (MSB), Inc.

[https://www.siliconbiosystems.com/en-us/] is announcing that the AMA has

issued Current Procedural Terminology (CPT(R)) 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 website[1].

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(R). 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

[https://www.ama-assn.org/about/cpt-editorial-panel/faq-editorial-panel-cpt-over

view].

[1]

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

Logo -  https://mma.prnewswire.com/media/1362208/Menarini_Logo.jpg

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

SOURCE: Menarini Silicon Biosystems