Biopharma & Clinical Testing

Our lab services leverage MSB’s specialized and integrated workflow, from the highly sensitive CELLSEARCH® platform for cell enumeration to the DEPArray™, for precise single-cell sorting and retrieval. Menarini Silicon Biosystems also has a proven track record of developing reproducible, customized assays for specific biomarkers of interest, combining cell enumeration and isolation expertise with clients’ individual research needs.

Clinical Trial Testing

  • Rare cell enumeration and single marker protein expression
  • Testing with our commercially available kits
  • Other rare cell testing available (eg, CMC)
  • Variety of protein markers with service tailored to enable customer success by developing customized assays

Pharma Test Menu

CLIA-Regulated Tests – US Only Research Use Only Tests – US and Italy
  • CELLSEARCH® CTC enumeration
  • CELLSEARCH® CXC-PD-L1 enumeration
  • CELLSEARCH® CMC enumeration
  • CTC enumeration
  • CTC cluster enumeration
  • CEC enumeration
  • CMC enumeration
  • CMMC enumeration
  • CTC profile
  • CTC Phenotyping Markers
  • PD-L1 (Programmed death-ligand 1)
  • HER2 (human epidermal growth factor receptor 2)
  • Ki-67 (marker of proliferation Ki-67)
  • AR (Androgen Receptor)

  • DEPArray™ single-cell sorting
The CMMC Assay will be submitted for CLIA certification in the US.

 

Cell Storage & Molecular Characterization of Rare Cells

  • Cell storage in glycerol for potential downstream applications
  • Profile kit enrichment
  • DNA & RNA extraction
  • DEPArray™-sorted cell molecular analysis with Ampli1™ Whole Genome Amplification (WGA) kits
    (available in the US only)

 

Using the Profile Kits, CTCs and CECs are captured and presented in a volume of 900 microliters.

  • Cells are captured alive and can be maintained and potentially propagated under appropriate tissue culture conditions.
  • No fixation, staining or permeabilization is performed during capture.
  • The enriched sample contains ferrofluid and a few thousand leukocytes which were non-specifically retained during the enrichment procedure.
  • Samples should be processed as soon as possible to maximize nucleic acid integrity and recovery.
  • Blood samples may be stored or transported in EDTA tubes at room temperature for up to 36 hours prior to processing. Note, however, that immediate processing is preferred since a loss of mRNA from epithelial cells may result if processing is delayed.

Commercial kits can be used for separate isolates of RNA, miRNA, DNA and proteins. We recommend utilizing kits that are designed for small samples since CTC-enriched samples rarely contain more than 10,000 cells.