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Biopharma

Biopharma

A Unique Offering of Custom Services and Expertise

Our Lab Services offer unique, specialized tools to expedite drug discovery and development programs from preclinical through Phase IV trials. They are also available to any research center interested in our Research Use Only test menu.

The Lab Services leverage our specialized and integrated workflow, from the highly sensitive CELLSEARCH® platform for enumeration of rare cells from blood to the DEPArray™, for precise single-cell sorting and retrieval. We also have 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.

LITERATURE DOWNLOAD

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Services Offered

  1. CLIA-REGULATED

    CLIA-regulated tests

    CLIA-regulated tests are available ONLY in the U.S. lab

    • CELLSEARCH® CTC enumeration
    • CELLSEARCH® CTC-HER2 enumeration
    • CELLSEARCH® CXC-PD-L1 enumeration
    • CELLSEARCH® CMC enumeration
    • CELLSEARCH® CMMC enumeration

  2. ENUMERATION ASSAYS

    Enumeration Assays

    For research use only. Available in the U.S. and European labs.

    ● Rare cell enumeration and single marker protein expression

    • Circulating Tumor Cells (CTC)
    • Circulating Melanoma Cells (CMC)
    • Circulating Multiple Myeloma Cells (CMMC)
    • Circulating Endothelial Cells (CEC)
    • CTC Her2 phenotyping
    • CTC PD-L1 phenotyping
    • CTC ER phenotyping
    • Other rare cells

    ● Testing with our commercially available kits

    ● Variety of protein markers with service tailored to enable customer success by developing customized assays

  3. ENRICHMENT AND STORAGE

    Enrichment for downstream molecular analysis & Storage

    For research use only. Available in the U.S. and European labs.

    ● Cell capture and enrichment for downstream molecular analysis. Circulating Tumor Cells are captured and isolated alive using the CTC Profile Kit. No fixation, staining or permeabilization is performed during capture. The enriched sample contains a few thousand leukocytes which are non-specifically retained during the enrichment procedure.

    ● DNA & RNA extraction

    ● Cell storage in glycerol for potential downstream applications

  4. SINGLE CELL ANALYSIS

    Single Cell Analysis for downstream applications

    For research use only. Available in the U.S. and European labs.

    ● Rare cell enrichment with CellSearch System.

    ● Single cell sorting with DEPArray PLUS platform. DEPArray PLUS allows to recover individual cells with 100% purity to overcome the limitations associated with bulk analysis of enriched samples and enables precise single cell molecular analysis.

    ● Single cell whole genome amplification with Ampli1™ WGA kit. NGS analysis for detection of genome-wide copy number aberrations and hotspot mutations with Ampli1 LowPass and Ampli1 OncoSeek kits.

  5. ADDITIONAL SERVICE

    Additional Service Offerings

    Linearity Panel

    A linearity panel is used to establish reportable range, and can show precision. It can be used as Verification of Performance Specifications (a CLIA requirement)

    • We provide 3 tubes of 4 spike levels (fixed cells in dilution buffer) as well as 14 tubes of donor blood.

    Concordance Study

    A concordance study establishes if an instrument is equivalent to another instrument and consists of only one spike level. Results can be used to comply with CLIA requirements.

    • We provide 14 tubes approx. 25 cells and the donor blood.



How the Service Works

In addition to careful lab practices, part of the ease and success in working with us is due to the technology. Patented CellSave™ and CellRescue™ tubes stabilize cells and allow for a 96-hour window (CellSave tubes) or 120-hour window (CellRescue tubes) from sample collection to sample testing, all at room temperature. This is in stark contrast to standard evacuated blood collection tubes, in which fragile cells can degrade within a few hours.

The time window allows for the confident convenience of coordinating multi-site studies, especially advantageous for rare diseases such as multiple myeloma or other rare cancers.



A proven partner to biopharma

In the United States, our Pennsylvania-based lab is CLIA/CAP accredited and ISO 15189-accredited, with licenses from New York, California, Maryland, Pennsylvania, and Rhode Island. The lab has processed over 25,000 samples, participated in almost 60 clinical trials, and has partnered with over 25 different pharmaceutical companies. 

The EU Clinical Lab located in Bologna is ISO 15189 accredited for the CELLSEARCH CTC Test. Such accreditation provides evidence of the managerial and technical adequacy of the laboratory with respect to the entire cycle of its activities. The concept of the Total Testing Process is therefore applied, verifying: staff competences, adequacy of the process for carrying out the tests and of its pre- and post-analytical phases (collection, transport and samples storage, review and results release), adequacy of the premises and equipment, metrological traceability of the results, quality assurance, ability of the management system to support and demonstrate the regular and consistent fulfillment of the requirements.

Together, the labs have over 13 years of experience in working closely alongside pharmaceutical and biotech companies, a relationship that thrives due to the core beliefs that samples are irreplaceable, and that more often than not, each study needs to be treated uniquely and with care. Throughout those years, all test sites have successfully completed regulatory and company audits with zero major findings.