Clinical Laboratory in Maryland

Maxim Biomedical is a vertically integrated in vitro diagnostics (IVD) development and manufacturing company with over 20 years of experience serving Fortune 100 companies and U.S. government agencies including the DoD, CDC, and NIH. The company provides end-to-end diagnostic solutions spanning assay development, product engineering, clinical and regulatory strategy, and full-scale manufacturing and fulfillment. Capabilities include antibody screening and conjugation, custom reagent and buffer formulation, lateral flow and ELISA immunoassay development, prototype and pilot-scale production, scalable manufacturing, reagent formulation and dispensing, device assembly and packaging, and in-process and final quality control testing. The company operates an FDA-registered, ISO 13485:2016-certified facility in environmentally controlled cleanrooms (ISO 5/7/8), with biochemistry and dry rooms. Manufacturing specialties include lateral flow, ELISA, and custom immunoassays with branded and private label solutions for retail, clinical, and government channels. Notable achievements include development and manufacturing of the ClearDetect® COVID-19 Antigen Home Test for the NIH RADx initiative and DoD, delivering 22+ million tests to the U.S. government, and a 15+ year partnership supporting Class III, BLA-regulated diagnostic products. The company serves as a contract development and manufacturing organization (CDMO) for diagnostics, supporting partners from early-stage concept through commercialization and sustained production.

Personal Genome Diagnostics (PGDx) is a precision oncology diagnostics company specializing in comprehensive genomic profiling (CGP) solutions for solid tumors. The company offers kitted genomic testing platforms designed to democratize access to cancer genomics in distributed laboratory settings worldwide. PGDx manufactures FDA-cleared and CE-IVD marked tissue and plasma-based assays that enable rapid, actionable genomic insights without requiring centralized laboratory infrastructure. The PGDx elio tissue complete test profiles 500+ solid tumor-related genes with somatic mutation identification including SNVs, indels, tumor mutational burden (TMB), microsatellite instability (MSI), and select amplifications and translocations. The PGDx elio plasma complete assay is a liquid biopsy solution analyzing circulating tumor DNA for biomarker discovery across pan-solid tumors, eliminating the need for invasive tissue sampling. Both platforms integrate proprietary bioinformatics for fully automated data analysis and clinical reporting. The company supports early-stage and late-stage biopharma services including biomarker discovery, companion diagnostic (CDx) development, and translational research. PGDx is now part of the LabCorp network, enhancing service delivery and clinical laboratory partnerships globally. Products are backed by turn-key bioinformatics enabling in-house testing and local control of genomic data.

RICCA Chemical Company LLC is a laboratory chemical supplier serving clinical, environmental, and production laboratory markets. The company manufactures and distributes a comprehensive line of chemicals, calibration standards, and certified reference materials (CRMs) designed to meet stringent analytical and quality-control requirements. Product offerings include pH buffer solutions, conductivity standards, ion chromatography (IC) standards, and PFAS (per- and polyfluoroalkyl substances) certified reference materials. RICCA emphasizes tight specifications and minimal lot-to-lot variability as competitive differentiators. The company holds ISO 9001:2015 certification for quality management and maintains ISO/IEC 17025 and ISO Guide 17034 accreditations for reference material production and testing laboratory competence. These accreditations underscore compliance with international standards for analytical measurement and traceability. RICCA serves laboratories requiring calibration standards for environmental testing, food safety, water quality analysis, and instrument calibration across multiple analytical techniques. The company offers custom chemical solutions tailored to specific instrument and application requirements. Online platforms include product search functionality, certificate-of-analysis lookup, and safety data sheet (SDS) access, supporting procurement efficiency for institutional and industrial customers.

Pearl Diagnostics is a Johns Hopkins University spin-off specializing in in vitro diagnostic assays for the detection of lung infections. The company's proprietary technology identifies circulating microbial extracellular vesicles (EVs) as biomarkers for early, non-invasive diagnosis of respiratory pathogens. Their lead product, MycoMEIA® Aspergillus Assay, received FDA 510(k) clearance in August 2025 and detects Aspergillus antigen in urine samples. The company is developing additional assays targeting common respiratory pathogens, including Pseudomonas aeruginosa, with support from the Cystic Fibrosis Foundation. Pearl Diagnostics serves infectious disease clinicians, pulmonologists, and hospital laboratories seeking non-invasive diagnostic tools for fungal and bacterial lung infections. The company provides technical support and educational resources to healthcare institutions.

Longhorn Vaccines and Diagnostics LLC is a veteran and family-owned biotech company with over 35 years of experience in human and animal public health. The company develops diagnostic tools, vaccines, and monoclonal antibodies targeting infectious diseases, antimicrobial resistance, and inflammatory conditions. Core products include PrimeStore® MTM, an FDA-cleared Class II molecular transport media (predicate device) for pathogen inactivation and RNA/DNA preservation in clinical samples; Salorn STM, a virucidal sample collection device for antigen testing; PrimeScreen MTB™, an oral screening kit for tuberculosis detection; PrimeSeqMDR, optimized PCR primers and reagents for MTB resistance gene amplification; and PrimeXtract™, a nucleic acid extraction system. In vaccines and therapeutics, Longhorn develops composite peptide vaccines addressing bacterial sepsis and antimicrobial-resistant infections, and monoclonal antibodies (e.g., LHNVD-501, LHNVD-303) targeting multi-drug resistant bacterial pathogens. The company is recognized by FDA, WHO, USDA, UK Health Department, and NHS. Manufacturing and supply partnerships are based in the United States, ensuring quality and accessibility. Longhorn's products address sample collection, transport, nucleic acid extraction, molecular testing, and therapeutic prevention of infectious and inflammatory disease.

CliniSys is a global leader in laboratory informatics with over 40 years of experience, serving approximately 7,000 laboratory organizations worldwide across healthcare, biotech, pharmaceutical, contract services, environmental, and public health sectors. The company specializes in configurable SaaS-based Laboratory Information Management Systems (LIMS) and Laboratory Information Systems (LIS) platforms that enable digital transformation, workflow customization, and regulatory compliance. CliniSys solutions support clinical diagnostics, microbiology, genetics, immunology, pathology, and molecular biology disciplines. Key offerings include the Clinisys Laboratory Solution™, WinPath Enterprise LIMS, Horizon LIMS, ApolloLIMS, and ICE Order Comms Software, with specialized modules for genetics, immunogenetics, and disease surveillance. The platform integrates laboratory data across diverse sources, enhancing operational efficiency, data analytics, and decision-making for diagnostic and testing services at scale.

Salmon Medic is a comprehensive medical equipment distributor and service provider offering end-to-end solutions for hospitals, clinics, academic institutions, and veterinary facilities. The company supplies a broad range of diagnostic, surgical, laboratory, and specialized medical equipment alongside procurement, installation, staff training, and after-sales support. Product categories include endoscopy systems, surgical instruments and equipment, orthopedic devices, laboratory analyzers and tools, veterinary equipment, furniture, and IVF solutions. Additionally, Salmon Medic serves industrial and workplace safety markets with first-aid kits, protective equipment, and emergency response supplies. The company emphasizes regulatory compliance (CE/FDA certification), quality assurance through rigorous QA protocols and certified calibration, and responsive local technical support. Services encompass supply chain management, field-proven reliability, continuous technical consultation, equipment upgrades, and training programs for healthcare professionals and medical students. Markets served include academic medical centers, nursing colleges, clinical laboratories, veterinary departments, and hospital systems seeking integrated equipment solutions with transparent pricing and clear service-level agreements.