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Cambridge Specialty Lab

ÃÛÌÒ´«Ã½¡¯s latest advancements at the Cambridge Specialty Lab have enhanced our ability to address unmet molecular biomarker testing needs and deliver flexible, cost-effective, and efficient solutions for sponsors requiring specialty laboratory testing.

Strong scientific NGS team

ÃÛÌÒ´«Ã½¡¯s NGS team brings over 12 years of expertise in developing, validating, and conducting NGS tests across various sample types in clinical trial settings. We have solidly validated NGS panels and often enhance commercial assays by improving specific features. Our strong capabilities in custom assay design and validation allow us to meet sponsors' clinical trial testing needs that commercial panels may not fulfill. We collaborate closely with sponsors to gather biomarker testing requirements, discuss assay design, validation strategies, and data reporting. Additionally, our experienced scientific team thoroughly reviews all reports by using IGV and other tools to eliminate false positives and incorporate any missed true variants, adding significant value to sponsors' clinical studies.

Broad NGS testing offerings

ÃÛÌÒ´«Ã½ has multiple types of NGS instruments to address different biomarker needs. Our Illumina sequencers include MiSeq, MiSeq Dx, NextSeq 550 Dx, and NovaSeq 6000; ThermoFisher platforms include Ion S5xl sequencer and Genexus. Using these platforms, ÃÛÌÒ´«Ã½ offers broad NGS tests to address variable biomarker testing requirements.

Comprehensive QC

ÃÛÌÒ´«Ã½ NGS lab performs comprehensive sample QC before testing to ensure high quality data and reduce sponsor cost. Our sample QC include DNA/RNA quantification by Qubit, TapeStation sizing QC, and qPCR for amplifiable molecules. ÃÛÌÒ´«Ã½ also performs thorough sequencing metrics QC and library metrics QC to ensure high data quality (no contamination, coverage meeting the assay requirement, and high uniformity of coverage). 

Efficiencies

NGS workflows have historically included manual processes for DNA/RNA, ctDNA extraction, and library preparation for NGS testing, which can be more time-intensive, and prone to executional variability during more complex procedures. ÃÛÌÒ´«Ã½¡¯s investment in innovative tools and systems, including automated extraction on Maxwell and Chemagic, library preparation automation on Hamilton, is part of a targeted automation strategy designed to support study-specific workflows to deliver sponsor results faster and more efficiently. 

Commitment to quality

ÃÛÌÒ´«Ã½¡¯s commitment to quality is core to the lab innovation strategy being implemented at our Cambridge facility. As ÃÛÌÒ´«Ã½ automates processes and platforms, we do so intentionally with a goal to improve our internal workflows and enhance the benefits we deliver to clients. The flexibility of options we have curated provides opportunities for accelerated timelines, right-sized custom workflows, and cost-effective services without compromising on quality.

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