Precision for Medicine

Human CD14+ Monocytes, Negatively Selected, 5-8 million

Flow cytometry and immunosequencing produce high-content data, which can be complex to mine—especially manually; our team infuses your research with efficiency and reproducibility.

Biomarker Statistics

Stratify patients, identify a novel drug target, or understand an MoA. Our team of experts deploys novel algorithms and strategies to uncover hidden insights.

Rapidly harmonize, synthesize, and visualize specialty lab data from multiple vendors and diverse assays.

With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

Our renowned scientific leadership helped establish the basis of FDA and EMA guidance in immunogenicity. Our passions include assays for PEGylated proteins, ADCs, bispecifics, gene therapies, CAR-T’s novel techniques such as drug-specific IgE assays, and assessments of complement activation.

Precision manages 25 million + biospecimens—with samples from over 100 active clinical trials on 6 continents. We house samples in LN 2 , at -80; -20; +4ºC; and ambient temperature—all conditions that are replicated in our biorepositories worldwide to ensure accurate, consistent research results.

We provide services under GLP and FDA guidelines for:

• ELISA based assays
• Cell based immunoassays

Capabilities:
- Kit-based, custom designed ELISA
- Sandwich, competitive, and bridging formats
- Optimization of protocols for commercial ELISA kits
- Analyze serum, plasma, celline supernatant's, cell lysates
- Analyze fluorescent/chemiluminescent/chromogenic/substrates

Equipment:
-Perkin Elmer, Envision/Enspire
-Multi-channel pipets

Number of samples processed in a single experiment: 72

Typical turn-around: 5 days

Flow cytometry (and immunophenotyping) for high-throughput, multi-parameter analysis of cell subsets (up to 18 colors, research, and CLIA).

ELISpot testing across multiple phases of clinical trials

Neutralizing antibody (cell- or non cell-based)

Reporter gene analysis GPCRs function

Cell viability, apoptosis / necrosis

At Precision for Medicine we understand that the route from assay development to commercialization is complex. So, our comprehensive suite of solutions is designed expressly to help your advanced in vitro, laboratory-developed, and companion diagnostics take the shortest path from test concept through clinical trial development, and over regulatory hurdles to reimbursement and market uptake.

We focus on the end from the very beginning, cutting through clutter and helping you reach your goal faster. Our integrated team understands how the pieces fit together, and ensures that learnings from each stage inform the rest of the process. The result: We’ve delivered more than 250 market clearances and approvals along with numerous favorable coverage and payment decisions for hundreds of diagnostic products—including many game-changing, first-to-market innovations

ELISpot testing across multiple phases of clinical trials

T- and B-cell proliferation

via flow cytometry (up to 18 colors, research, and CLIA)

Immune function (T, B, NK, NKT, Treg, Neutrophils)

With real-time sample processing occurring in over 50 countries on 6 continents, we are able to manage the sample from draw to assay, streamlining handling and ensuring sample preservation, integrity, and consistency.

We build our custom cell-based assays using cell lines or primary cells (both normal and patient-derived). We also deliver novel ligand-binding assay approaches for greater ease of validation and scalability. Our assays are run routinely to support preclinical and clinical studies.

Whether you have high-throughput genomic data or high-content data for immune monitoring, we can meet the challenges of managing, analyzing, and synthesizing it to accelerate new discoveries, identify drug targets, characterize MoAs, and develop biomarkers for patient selection. This work is grounded in passion: For translational informatics and data science. For genomics and computational biology. For biostatistics. Throughout, we accelerate decision making by leveraging our translational informatics platform, PATH™.

Human Normal Plasma, 10 mL

Available in 10M for: Acne, Asthma, Celiac Disease, CLL, COPD, Crohn's Disease, Diabetes Type I&II, HIV, HIV Treatment Naive, HIV-2, Lupus (SLE), Psoriasis, Rheumatoid Arthritis, Ulcerative Colitis

Highly annotated cryopreserved PBMCs are available from inventory. Data includes donor demographics, date of diagnosis, and current medications.

Available in 10 million cells/vial
At least three lots in inventory from each disease state
Match plasma aliquots available for each lot
HLA Class-I and Class-II information available

Tailored solutions—from custom assays to standard panels across multiple platforms—implemented at a global scale to achieve your trial objectives

Human Pan-T Cells, Negatively Selection, 5 million

Human CD8+ T-Cells, Negatively Selected, 5-8 million

Human CD4+ T-Cells, Negatively Selected, 5-8 million

Human CD19+ B-Cells, Negatively Selected, 5-8 million

Our facilities have access to donors with various disease states including COPD, Diabetes Type I&II, HIV, Lupus, Rheumatoid Arthritis, Crohn’s Disease, Celiac Disease, Ulcerative Colitis, Diabetes, Multiple Sclerosis and other autoimmune disorders.

Half-packs available
Average 4 billion leukocytes
Option to characterize by HLA Class I & Class II available

Fresh Human Leukopak, Normal, Full Pack

Each leukopak has roughly 10 billion leukocytes and up to 200 to 300 mL of matched plasma from a single healthy donor.

Full and half-packs available
Average 10 billion leukocytes
Option to characterize by HLA Class I & Class II available

Biomarker data management is a key step in every clinical bioinformatics study. Approximately 40% of the overall analysis time is dedicated to these tasks, which are crucial for the quality of the overall analysis.

Biomarker data management involves the integration and consistency checking of data collected from different domains. These can range from patient data provided by the clinics, to data generated in the lab by biological analysis platforms. The data management solutions developed by Quartz Bio allow to flexibly integrate data from different origins and formats. Consitency checks are then performed by analysts with a biotechnological knowledge of the data. All the data management processes are documented, auditable and reproducible. Robust data management ensures that the data analyses are developed on a solid ground.

Biomarker data management involves different steps:

• Parse of the different files and integration into a “biomarker database”
  
• Verification of the consistency of the identifiers (subject ids, visits, biomarkers, etc) across the different datasets
  
• Standardisation of the variable names
  
• Check of formats and variable ranges (compared to data specifications)
  
• Derivation of variables specific to the biomarker data analysis
  

Quality Control

Biomarker data are heterogeneous. Technology-specific quality controls must be applied in order to identify possible sources of bias that could impact the analysis. The biology behind the assay and the sample logistics in clinical settings are two of the most important factors that can impact the biomarker data quality.

Each drug discovery program and each company has its own processes. Furthermore, it is not rare that multiple partners and collaborators are involved.

At Quartz Bio, we can also bring our biological and computational expertise to customize methods and applications to your own needs to facilitate data management and subsequent analysis.

Non exhaustive list of Methods development projects developed at Quartz Bio:

• RNASeq quality control pipeline
  
• Fluidigm qPCR data analysis pipeline and R package
  
• Pipeline for analysis of immune-repertoire sequencing data
  
• Data extraction form back-log of PDF files
  
• Query and visualization tool for genotoxicity tests database
  
• Transmart DB maintainer for EU industrial programs
  
• Evaluation of bioinformatic databases

In every study, the design is key. It is particularly true in exploratory biomarker studies, where statistical power cannot be controlled and where sample logisitics can have an important impact on input data quality and availability.

Quartz Bio data scientists have analysed numerous biomarker studies and have experienced many cases where design flaws impacted negatively the analysis.

This expertise is routinely used a posteriori in the Quality Control process, but could also better be used before generating the data, i.e. at the design stage. Thus, reviewing the exploratory part of the Clinical Study Protocol and affiliated documents such as Analytical Plans or Manual of Operations could permit optimising the biomarker study design.

DNA Sequencing Services

DNA Services