3193 Lionshead Suite 200 Carlsbad, CA, 92010 United StatesFor more than 20 years, DCN Dx has done one thing: help companies bring diagnostic tests to commercial success. Today, the company runs three specialized businesses: A biospecimen solutions business. A clinical trial services business and an immunoassay CDMO. Our biospecimen solutions business gives test developers global access to IRB/IEC-governed samples, including prospective collections, across oncology, autoimmune, and infectious disease, areas providing the clinical proof they need to move a test from bench to real-world validation. Our IVD-dedicated CRO is led by former sponsor-side experts who carried their own diagnostics through FDA and EU IVDR review and now design and manage clinical studies and regulatory submissions through to approval. Our immunoassay CDMO has completed more than 560 programs and is the industry’s go-to for developing and manufacturing rapid point-of-use tests, from early feasibility through full-scale production in a 35,000-square-foot facility certified to ISO 13485 and ISO 9001. DCN Dx works with startups and established IVD manufacturers alike, meeting each client wherever its test stands on the way to market. Based in Carlsbad, CA. Learn more at dcndx.com. Keywords: custom prospective collection, prospective biospecimen collection, prospective specimen collection, prospective sample collection, custom biospecimen collection, protocol-based collection, custom sourcing, specimen procurement, biospecimen procurement, sample procurement, custom specimen sourcing, prospective cohort, fresh collection, companion diagnostic, CDx, companion diagnostic development, CDx development, companion diagnostic specimens, CDx specimens, CDx validation, drug development specimens, translational research samples, precision medicine specimens, pharmacogenomics, biomarker discovery, biomarker validation, biomarker specimens, biomarker samples, assay development, assay validation, clinical validation, analytical validation, IVD development, in vitro diagnostic development, diagnostic test development, liquid biopsy specimens, liquid biopsy samples, MCED, multi-cancer early detection, minimal residual disease, MRD, early cancer detection, NGS specimens, genomics samples, molecular diagnostics samples, IHC specimens, proteomics samples, methylation specimens, FDA validation cohort, clinical performance study specimens, clinical trial specimens, reference specimens, characterized specimens, control material, annotated specimens, clinically annotated samples, biospecimens, biospecimen, specimens, samples, human biospecimens, human samples, human biological specimens, clinical specimens, clinical samples, research specimens, research samples, matched sets, matched specimen sets, matched samples, matched pairs, matched tumor normal, longitudinal specimens, longitudinal samples, serial specimens, banked specimens, biorepository inventory, off-the-shelf specimens, ready-to-ship specimens, inventory samples, validation cohort specimens, normal cohort samples, FFPE, FFPE blocks, FFPE tissue, FFPE slides, formalin fixed paraffin embedded, tissue blocks, tissue microarray, TMA, fresh tissue, fresh frozen tissue, frozen tissue, snap frozen tissue, OCT tissue, fresh tumor tissue, viable tumor cells, tumor tissue, tumor specimens, tumor samples, cancer tissue, normal adjacent tissue, NAT, whole blood, blood samples, blood specimens, peripheral blood, serum, serum samples, plasma, plasma samples, EDTA plasma, cfDNA plasma, PBMC, PBMCs, peripheral blood mononuclear cells, buffy coat, leukopak, urine, urine samples, saliva, saliva samples, oral swab, buccal swab, nasal swab, nasopharyngeal swab, swab specimens, stool, stool samples, fecal samples, CSF, cerebrospinal fluid, bone marrow, bone marrow aspirate, ctDNA, cfDNA, circulating tumor DNA, cell free DNA, circulating tumor cells, CTC, extracted DNA, extracted RNA, nucleic acids, ascites, pleural effusion, body fluids, biofluids, oncology, cancer specimens, cancer samples, oncology specimens, solid tumor, solid tumors, hematologic malignancy, leukemia, lymphoma, breast cancer, lung cancer, NSCLC, colorectal cancer, CRC, prostate cancer, pancreatic cancer, ovarian cancer, melanoma, bladder cancer, kidney cancer, liver cancer, HCC, gastric cancer, head and neck cancer, glioblastoma, neurology, neurodegenerative disease, Alzheimer's disease, Alzheimers, dementia, mild cognitive impairment, MCI, Parkinson's disease, autoimmune disease, rheumatoid arthritis, lupus, SLE, multiple sclerosis, inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, psoriasis, Graves disease, autoimmune thyroid disease, Hashimoto's, type 1 diabetes, cardiometabolic disease, cardiovascular disease, type 2 diabetes, metabolic disease, NASH, MASH, obesity, women's health, womens health, reproductive health, pregnancy specimens, prenatal, endometriosis, PCOS, gynecological specimens, infectious disease, viral infection, respiratory infection, influenza, COVID-19, SARS-CoV-2, RSV, hepatitis, HIV, sepsis, tuberculosis, STI, respiratory disease, COPD, asthma, pulmonary disease, normal controls, healthy controls, healthy donors, normal specimens, normal samples, control samples, disease-free specimens, diverse cohorts, diverse specimens, demographically diverse specimens, demographically diverse samples, diverse patient cohorts, population representation, self-identified race, genetic ancestry, ancestry-characterized specimens, ancestrally diverse specimens, multi-ethnic specimens, representative cohorts, intended use population, IRB approved, IRB-approved specimens, informed consent, consented specimens, ethically sourced, ethically sourced specimens, ethically sourced samples, ISO 13485, ISO 9001, ISO certified, IVDR, IVDR compliant, FDA validation, chain of custody, GDPR compliant, HIPAA compliant, de-identified specimens, coded specimens, standardized collection, SOP-driven collection, pre-analytical quality, high quality biospecimens, GCP, CRO, contract research organization, clinical research services, clinical study support, clinical trial support, clinical operations, patient recruitment, site management, specimen logistics, cold chain logistics, sample processing, biospecimen processing, regulatory strategy, regulatory affairs, regulatory consulting, IVD regulatory, 510k, De Novo, PMA, regulatory pathway, submission support, CDMO, contract development and manufacturing, assay manufacturing, cfDNA processing, plasma processing, nucleic acid extraction, sample QC, biospecimen supplier, biospecimen provider, biospecimen vendor, specimen supplier, sample provider, human tissue supplier, biospecimen partner, specimen sourcing partner, biospecimen sourcing company, sample sourcing

6354 Corte del Abeto, Suite B, Carlsbad, CA USA 92011For more than 20 years, DCN Dx has done one thing: help companies bring diagnostic tests to commercial success. Today, the company runs three specialized businesses: A biospecimen solutions business. A clinical trial services business and an immunoassay CDMO. Our biospecimen solutions business gives test developers global access to IRB/IEC-governed samples, including prospective collections, across oncology, autoimmune, and infectious disease, areas providing the clinical proof they need to move a test from bench to real-world validation. Our IVD-dedicated CRO is led by former sponsor-side experts who carried their own diagnostics through FDA and EU IVDR review and now design and manage clinical studies and regulatory submissions through to approval. Our immunoassay CDMO has completed more than 560 programs and is the industry’s go-to for developing and manufacturing rapid point-of-use tests, from early feasibility through full-scale production in a 35,000-square-foot facility certified to ISO 13485 and ISO 9001. DCN Dx works with startups and established IVD manufacturers alike, meeting each client wherever its test stands on the way to market. Based in Carlsbad, CA. Learn more at dcndx.com. Keywords: custom prospective collection, prospective biospecimen collection, prospective specimen collection, prospective sample collection, custom biospecimen collection, protocol-based collection, custom sourcing, specimen procurement, biospecimen procurement, sample procurement, custom specimen sourcing, prospective cohort, fresh collection, companion diagnostic, CDx, companion diagnostic development, CDx development, companion diagnostic specimens, CDx specimens, CDx validation, drug development specimens, translational research samples, precision medicine specimens, pharmacogenomics, biomarker discovery, biomarker validation, biomarker specimens, biomarker samples, assay development, assay validation, clinical validation, analytical validation, IVD development, in vitro diagnostic development, diagnostic test development, liquid biopsy specimens, liquid biopsy samples, MCED, multi-cancer early detection, minimal residual disease, MRD, early cancer detection, NGS specimens, genomics samples, molecular diagnostics samples, IHC specimens, proteomics samples, methylation specimens, FDA validation cohort, clinical performance study specimens, clinical trial specimens, reference specimens, characterized specimens, control material, annotated specimens, clinically annotated samples, biospecimens, biospecimen, specimens, samples, human biospecimens, human samples, human biological specimens, clinical specimens, clinical samples, research specimens, research samples, matched sets, matched specimen sets, matched samples, matched pairs, matched tumor normal, longitudinal specimens, longitudinal samples, serial specimens, banked specimens, biorepository inventory, off-the-shelf specimens, ready-to-ship specimens, inventory samples, validation cohort specimens, normal cohort samples, FFPE, FFPE blocks, FFPE tissue, FFPE slides, formalin fixed paraffin embedded, tissue blocks, tissue microarray, TMA, fresh tissue, fresh frozen tissue, frozen tissue, snap frozen tissue, OCT tissue, fresh tumor tissue, viable tumor cells, tumor tissue, tumor specimens, tumor samples, cancer tissue, normal adjacent tissue, NAT, whole blood, blood samples, blood specimens, peripheral blood, serum, serum samples, plasma, plasma samples, EDTA plasma, cfDNA plasma, PBMC, PBMCs, peripheral blood mononuclear cells, buffy coat, leukopak, urine, urine samples, saliva, saliva samples, oral swab, buccal swab, nasal swab, nasopharyngeal swab, swab specimens, stool, stool samples, fecal samples, CSF, cerebrospinal fluid, bone marrow, bone marrow aspirate, ctDNA, cfDNA, circulating tumor DNA, cell free DNA, circulating tumor cells, CTC, extracted DNA, extracted RNA, nucleic acids, ascites, pleural effusion, body fluids, biofluids, oncology, cancer specimens, cancer samples, oncology specimens, solid tumor, solid tumors, hematologic malignancy, leukemia, lymphoma, breast cancer, lung cancer, NSCLC, colorectal cancer, CRC, prostate cancer, pancreatic cancer, ovarian cancer, melanoma, bladder cancer, kidney cancer, liver cancer, HCC, gastric cancer, head and neck cancer, glioblastoma, neurology, neurodegenerative disease, Alzheimer's disease, Alzheimers, dementia, mild cognitive impairment, MCI, Parkinson's disease, autoimmune disease, rheumatoid arthritis, lupus, SLE, multiple sclerosis, inflammatory bowel disease, IBD, Crohn's disease, ulcerative colitis, psoriasis, Graves disease, autoimmune thyroid disease, Hashimoto's, type 1 diabetes, cardiometabolic disease, cardiovascular disease, type 2 diabetes, metabolic disease, NASH, MASH, obesity, women's health, womens health, reproductive health, pregnancy specimens, prenatal, endometriosis, PCOS, gynecological specimens, infectious disease, viral infection, respiratory infection, influenza, COVID-19, SARS-CoV-2, RSV, hepatitis, HIV, sepsis, tuberculosis, STI, respiratory disease, COPD, asthma, pulmonary disease, normal controls, healthy controls, healthy donors, normal specimens, normal samples, control samples, disease-free specimens, diverse cohorts, diverse specimens, demographically diverse specimens, demographically diverse samples, diverse patient cohorts, population representation, self-identified race, genetic ancestry, ancestry-characterized specimens, ancestrally diverse specimens, multi-ethnic specimens, representative cohorts, intended use population, IRB approved, IRB-approved specimens, informed consent, consented specimens, ethically sourced, ethically sourced specimens, ethically sourced samples, ISO 13485, ISO 9001, ISO certified, IVDR, IVDR compliant, FDA validation, chain of custody, GDPR compliant, HIPAA compliant, de-identified specimens, coded specimens, standardized collection, SOP-driven collection, pre-analytical quality, high quality biospecimens, GCP, CRO, contract research organization, clinical research services, clinical study support, clinical trial support, clinical operations, patient recruitment, site management, specimen logistics, cold chain logistics, sample processing, biospecimen processing, regulatory strategy, regulatory affairs, regulatory consulting, IVD regulatory, 510k, De Novo, PMA, regulatory pathway, submission support, CDMO, contract development and manufacturing, assay manufacturing, cfDNA processing, plasma processing, nucleic acid extraction, sample QC, biospecimen supplier, biospecimen provider, biospecimen vendor, specimen supplier, sample provider, human tissue supplier, biospecimen partner, specimen sourcing partner, biospecimen sourcing company, sample sourcing