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Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays _ NorthEast BioLab

Biomarker testing is a method for searching for qualities, proteins, and different substances (called biomarkers or growth markers) that can give data about disease. Every individual's malignant growth has an interesting example of biomarkers. Some biomarkers influence how specific malignant growth medicines work.<br>Biomarker testing Service, which is now and then alluded to as "sub-atomic testing" or "hereditary testing," is finished by acquiring a limited quantity of tissue (called a biopsy) from a patient's growth, or by drawing a blood test; the tissue or blood test is shipped off a lab for

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Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays _ NorthEast BioLab

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  1. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search Home Biomarker Lab Testing Services Outstanding Biomarker Lab And Assay Validation Services CRO For Your Cytokine Testing! Preclinical/Clinical Biomarker Lab Testing Services For 1,000+ Analytes Expedited Biomarker Assay Development On ELISA, Luminex, MSD, LC-MS/MS, qPCR, Western Blot, etc GLP Or Fit-For-Purpose Biomarker Assay Validation And Bioanalysis FDA Audited Biomarker Testing CRO For Small And Large Molecules Provide Your Bioanalysis Study Details We Will Contact You Within 1 Business Day First Name* Last Name Email* Phone https://www.nebiolab.com/biomarker-testing-assay/ 1/12

  2. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists How Can We Help You?* Include Details, Such As Test Article, Bioanalytical Method, # Of Samples, GLP/Non-GLP, Etc. REQUEST QUOTE Search SPEAK TO OUR SCIENTISTS Click below For Answers To Your Biomarker Testing Questions - What are Biomarker Testing Services? How to perform Biomarker Assay Development and Validation? Which Biomarker Analysis Services do you offer? Why choose us for your Biomarker Analysis and Cytokine Testing Services? Biomarker Testing Lab CRO Trusted By Biotech Over 15+ Years! Biomarker Testing Services At Industry-Leading Turnaround Tailor-Made, High-Value Biomarker Assays Services For Biotech Preclinical/Clinical Biomarker Testing On ELISA, Luminex, MSD, LC-MS/MS, qPCR, Western Blot, etc Biomarker Lab CRO Service For Small And Large Molecules SPEAK TO OUR SCIENTISTS https://www.nebiolab.com/biomarker-testing-assay/ 2/12

  3. 12/10/21, 6:32 PM What Are Biomarker Testing Services? Email Your Inquiry Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com (203) 361 3780 Speak to Our Scientists Biomarker Testing and Analysis: Quantitate Biological/Pathogenic Processes or Pharmacologic Response to Therapy in the Body REQUEST QUOTE Biomarker testing services provide a powerful approach to measuring biological process indicators in normal and pathological conditions or in response to pharmacological intervention. Biomarker analysis in blood or other bodily fluids at either the DNA or protein level has been used by physicians for decades to study human diseases. Physicians readily rely on biomarker services to diagnose and manage clinical conditions such as cardiovascular diseases, cancer, immune responses, and genetic disorders. However, the application of biomarker assay in research has recently exploded out of a desire to gain crucial information about biological reactions upon exposure to novel therapeutic compounds. Search Clinical biomarkers in drug discovery and development are crucial at all phases, from drug discovery to first in human trials. Biomarker assay services are used extensively in the earlier stages of the drug discovery process for mechanistic or pharmacodynamic purposes such as determining the mechanism of action, validating drug targets, monitoring therapeutic responses, and guiding compound selections. Thus, early biomarker analysis services measure biological response and helps decide whether potential therapeutic agents should be pursued further or discontinued. Later in the drug development process, biomarker testing is expanded to include clinical biomarker services for patient screening and treatment. These clinical studies include diagnostic, prognostic, and safety biomarker lab services to examine patient populations, patient risks/responses to treatment, and clinical endpoints. For example, biomarker testing services have been used extensively in drug discovery for cancer resulting from the changes in a cell’s genetic material. Specifically, biomarker analysis services have been used to quantitate these inter and intracellular changes associated with various cancers. One use of biomarker services for cancer lies in evaluating the impact of a drug/compound on cancer cells’ growth. Scientists assess genomic changes, abnormal features, or biochemical effects of the tumor during cancer’s biomarker assay testing to identify the disease’s reproducible signs. Biomarker analysis relies on correlating markers identified previously to categorize samples by disease stage or treatment efficacy. As a nimble Biomarker CRO, we offer singleplex or multiplex assays on the MSD or Luminex platforms or as commercially available ELISA assays evaluated using a traditional 96 well plate format. All these assays undergo a fit for purpose biomarker validation, including assessing bioanalytical parameters such as accuracy, precision, and sensitivity. Once the biomarker assay is well characterized and robust, it can be relied upon to analyze preclinical or clinical study samples. As a GLP certified CRO specializing in biomarker assay development, we maintain high-quality standards that meet our sponsor and regulatory agency needs. Some of our most popular biomarker assay services include assay development, method validation, and cytokine testing. https://www.nebiolab.com/biomarker-testing-assay/ 3/12

  4. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists What Our Sponsors Have To Say? REQUEST QUOTE VP, PK Top 10 Pharma Search Executive Director, Drug Researc Biotech Our projects with NorthEast BioLab include method development, stability studies, cross- validation of other labs, support for investigator- sponsored studies, and Clinical Phase I – IV studies. They have considerably exceeded our expectations time and again. NorthEast BioLab provided critical insight into analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend them and look forward to working together in the future. ‹ › Ready To Take The First Step? Consult with a Scientist About Your Biomarker Lab Testing Services SPEAK TO OUR SCIENTISTS How To Perform Biomarker Assay Development and Validation? Fit for Purpose (FFP) Biomarker Assay Development and Validation Biomarker assay development and validation are crucial in establishing a robust bioanalytical method to quantify a specific biological response in our chosen biological matrix. Afterward, biomarker analysis plays a significant role in assessing the efficacy and safety of novel or repurposed therapeutic compounds. US FDA and other regulatory agencies require fit for purpose (FFP) biomarker validation and assay characterization depending on expected context of use (COU) to ensure data integrity and reproducibility fundamental to each clinical trial's success. https://www.nebiolab.com/biomarker-testing-assay/ 4/12

  5. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab Biomarker assay development begins by examining the biomarker of interest, selecting a suitable analysis platform, and surveying available or made-to-order materials such as kits, recombinant or natural reference proteins, capture/detection antibody pairs, diluents, buffers, substrates, reagents, control matrices, etc. Next, we perform a pre-validation test run of the biomarker assay with calibration standards and quality controls to analyze a few sponsor samples in duplicate. Once the preliminary biomarker development is complete, our team of expert scientists performs proper validation for each of your biomarker services to demonstrate method reliability for the intended use. Search sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE For early drug development, such as compound selection or proof of concept, the extent of biomarker validation depends on sponsor preference. Generally, US FDA recommends full biomarker assay validation if the study results will inform regulatory decision-making, such as ascertaining drug safety or product labeling. Per FDA biomarker method validation guidance, we must evaluate all critical assay parameters to lie within approved acceptance criteria for accuracy, precision, selectivity, sensitivity, dynamic range, etc. Furthermore, biomarker validation may also cover stability, parallelism, specificity, dilution effects, and prozone effect. We hold extensive expertise in a wide range of biomarker assay development and validation services to meet your needs through all stages of the drug development process. Specifically, our biomarker assay services include custom assays using proprietary or commercially available antibodies, research use only (RUO) kits, and singleplex or multiplex MSD or Luminex assays. Additionally, we perform your preclinical and clinical biomarker testing after necessary assay validation. https://www.nebiolab.com/biomarker-testing-assay/ 5/12

  6. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search Biomarker Assay List https://www.nebiolab.com/biomarker-testing-assay/ 6/12

  7. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab Biomarker research, discovery, and qualification are pivotal in modern drug development from demonstrating proof-of-concept (POC) to establishing drug safety and efficacy in the clinic… Email Your Inquiry sales@nebiolab.com (203) 361 3780 Speak to Our Scientists REQUEST QUOTE EXPLORE OUR BIOMARKER LIST Search Which Biomarker Analysis Services Do You Offer? Biomarker Assay, Analysis, and Testing Services Offered by NorthEast BioLab As a Biomarker CRO, NorthEast BioLab offers end-to-end biomarker analysis during drug discovery, preclinical and clinical studies. Our scientists have extensive experience setting up biomarker assays to quantitate proteins, peptides, and small molecules in various biological matrices such as blood, plasma, serum, urine, cerebrospinal fluid (CSF), organ tissue homogenate, etc. These biomarker studies can be performed using a traditional ELISA assay or one of our advanced biomarker assay platforms ( LC-MS/MS, MSD ECL, Luminex Multiplex). Thus, you can leverage our biomarker testing services for 1,000+ analytes on MSD, Luminex, ELISA, LC-MS/MS, qPCR, and Western Blot. Our FDA audited biomarker CRO’s veteran scientists help select the best assay platform and materials for your preclinical and clinical study. We deliver GLP or fit-for-purpose biomarker assay development, validation, and sample analysis for proteins, peptides, and small molecules at industry-leading value and turnaround. Speak to our scientists to get started on your biomarker analysis or cytokine testing. We offer these biomarker testing services for analysis of your study samples through custom assay development or commercially available assay kits: Custom Biomarker Assay Development, Validation, and Analysis Biomarker Testing Services using Commercial Assays and Kits Registered and Inspected by Various Regulatory Agencies https://www.nebiolab.com/biomarker-testing-assay/ 7/12

  8. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab Why Choose Us For Your Biomarker Analysis and Cytokine Testing Services? sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Appropriate Biomarker Validation and Testing Assay for your Crucial Study Endpoints Search NorthEast BioLab has 15+ years track record of various biomarker analysis services for proteins, peptides, and small molecules. Using our industry knowledge, we can accelerate your biomarker assay development, validation, and sample analysis. Our scientists offer dependable biomarker testing services to generate actionable and reproducible data for Sponsors. To that end, we perform fit-for-purpose (FFP) validation for biomarker research to demonstrate assay reliability for the intended use. We ensure high ROI on your biomarker study by fine-tuning commercially available research use only (RUO) kits, pre- validated singleplex assays, or multiplex biomarker panel as per your requirements. Contact us today for a comprehensive analyte menu grouped by species, abundance in tested matrices, multiplex compatibility, LOD/LLOQ/ULOQ range, and regular therapeutic use. Our team understands that Biomarker assay testing is a crucial aspect of drug discovery and clinical research. It allows biomarker experts to evaluate the impact therapeutic regimens have on various pathological conditions. Biomarker analysis services early in the development phase can identify potential targets and drug candidates and monitor therapeutic responses. Later in the process, clinical biomarker testing is available to address safety and efficacy concerns. We leverage our expertise in GLP biomarker assay testing and complete extensive pre-validation analysis. Specifically, we carefully review the available literature on the biomarkers and assay materials to meet your unique needs. Afterward, we develop a biomarker study plan to partner with the sponsor flexibly, turn around initial data within weeks, iterate biomarker assay, and provide control over sample analysis. Furthermore, we accept biological samples from sponsors for biomarker discovery services as well. Our veteran scientists perform cytokine or chemokine analyses using LC-MS/MS, ELISA, MSD, Luminex Multiplex, qPCR, and Western Blot biomarker assay platforms. Each biomarker solution has guard rails around capabilities, e.g., which and how many analytes could be multiplexed? Our team does the groundwork to recommend the best biomarker assay platform based on your analytes of interest. Generally, sample analysis effort depends on several factors, such as # of samples, fit for purpose validation (exploratory, fully validated), etc. Sample preparation is an integral part of biomarker assay testing as it dictates the robustness, sensitivity, and selectivity of the test. We ensure full sample chain of custody for biomarker study as contamination and degradation of biological matrices can significantly impact data quality. Our lab analysts follow the best sample handling practices to minimize the effect of these factors. Thus, we work towards enhancing your sample stability throughout the drug discovery and development from collection to storage. As biomarker experts, we can provide consulting and biomarker testing services at all drug development stages. Above all, we encourage intensive collaboration between our sponsors and scientists for complete transparency throughout your biomarker study with us. NorthEast BioLab offers quick turnaround times, scalability, and flexibility, given our extensive experience with biomarker assay development and https://www.nebiolab.com/biomarker-testing-assay/ 8/12

  9. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab validation and a thorough understanding of the science behind it. Thus, our objective of clinical biomarkers in drug discovery and development is to measure a biological response accurately and help you make a scientific decision of whether potential therapeutic agents should be pursued further or discontinued. We enable our sponsors to expedite drug approval through efficient assay development, validation, and optimization while maintaining 100% regulatory compliance. sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Search Still Have Questions Regarding Your Biomarker Lab Testing Services? The Scientists At NorthEast BioLab are Ready to Help! SPEAK TO OUR SCIENTISTS Related FAQs Answers to additional Biomarker Testing and Assay Validation Services questions popular among our potential clients. What are Biomarkers, and why are they useful? What is Biomarker Testing and Analysis? Which Biomarker Testing do you offer? How do you perform Biomarker Testing? Which platforms are used for Biomarker Research and Analysis? What is the need for Biomarker Assay during Drug Development? What are Biomarker Discovery Services? What are Biomarker Development Services? https://www.nebiolab.com/biomarker-testing-assay/ 9/12

  10. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists What are Biomarker Validation Services? REQUEST QUOTE What are Biomarker Qualification Services? Search How can Biomarker Testing improve the Drug Development process? Explore More Services Pharmacokinetics (PK) Study Toxicology (Tox) Study Biomaker Testing Services Bioequivalence and Bioavailability Studies Immunogenicity Testing Bioanalytical Assay Expertise Services https://www.nebiolab.com/biomarker-testing-assay/ 10/12

  11. 12/10/21, 6:32 PM Solutions Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists About Us REQUEST QUOTE Resources Search Consult with a Scientist Now We Will Contact You Within 1 Business Day First Name* Last Name Email* Phone How Can We Help You?* Include Details, Such As Test Article, Bioanalytical Method, # Of Samples, GLP/Non-GLP, Etc. SPEAK TO OUR SCIENTISTS 925 Sherman Avenue Hamden, CT 06514 sales@nebiolab.com (203) 361 3780 https://www.nebiolab.com/biomarker-testing-assay/ 11/12

  12. 12/10/21, 6:32 PM Biomarker Lab CRO, Biomarker Testing Services, Biomarker Assays | NorthEast BioLab sales@nebiolab.com Email Your Inquiry (203) 361 3780 Speak to Our Scientists REQUEST QUOTE Privacy Policy Terms of Use Sitemap © 2019 - 2025, NorthEast BioAnalytical Laboratories LLC. All rights reserved. Search https://www.nebiolab.com/biomarker-testing-assay/ 12/12

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