Clinical Laboratory in New York

IMMCO Diagnostics is a clinical reference laboratory located in Buffalo, NY, specializing in serological and biopsy testing for autoimmune diseases and pregnancy-related complications. Licensed throughout the United States, the company offers diagnostic testing for Sjögren's syndrome, Rheumatoid Arthritis, Celiac Disease, Ulcerative Colitis, Crohn's Disease, Systemic Lupus Erythematosus, and Scleroderma. The laboratory is known for developing proprietary biomarkers, including novel SP-1, CA-6, and PSP markers for Sjögren's syndrome that increase diagnostic sensitivity above 80% before traditional antibodies appear. IMMCO also provides preeclampsia risk assessment testing using FDA-cleared biomarkers (sFlt-1 and PlGF) with KRYPTOR instrumentation to guide early clinical intervention and reduce maternal-fetal complications. The company was co-founded by periodontists and maintains specialized Oral and Maxillofacial pathology services with over 40 years' experience; staff includes board-certified oral and immune pathologists offering case consultations and second opinions. Services include individual tests, panels, genetic testing for autoimmune conditions, and family screening. The laboratory operates as a reference service provider, accepting specimens from healthcare providers nationwide.

Oxford Gene Technology (OGT) is a precision genomics company specializing in molecular diagnostics for clinical and research laboratories. The company develops and manufactures hybridization-based FISH (fluorescence in situ hybridization), NGS (next-generation sequencing), and array-based genomic solutions for haematological malignancies, solid tumours, cytogenetics, and rare disease detection. OGT's primary product portfolio includes CytoCell FISH probes, SureSeq NGS panels, and CytoSure arrays. Recent offerings include the SureSeq Myeloid MRD Plus NGS Panel for minimal residual disease detection in acute myeloid leukaemia, and the FDA-authorized CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic for KMT2A-rearranged acute leukaemia. OGT provides end-to-end support from assay design through clinical implementation, including precision medicine partnering for clinical trial and companion diagnostic development. The company serves clinical diagnostic laboratories, research institutions, and oncology centers globally, with established partnerships and customer bases across North America, Europe, and international markets. OGT's technical support is provided by personnel with laboratory backgrounds, supporting implementation of test workflows and biomarker interrogation. The company holds FDA authorizations for companion diagnostics and operates under clinical laboratory standards for genomic testing.

Micro Essential Laboratory, Inc. is a US-based manufacturer of pH testing products and sanitizer test kits, operating since 1934. The company specializes in pH indicator papers, pH strips, pH test kits, and sanitizer test kits under the Hydrion® and pHizatest® product brands. Products are manufactured in the USA and designed for clinical laboratories, healthcare facilities, food service operations, educational institutions, and environmental/safety applications. The Hydrion® line includes pH paper, pH strips in flip-top vials, pH buffer standards, and specialty test papers. pHizatest® products feature FDA-listed nitrazine indicator paper. Sanitizer test kits are marketed for health code compliance and contamination avoidance in food service and healthcare settings. The company offers private labeling and custom packaging services for bulk orders. All products are manufactured in the USA and emphasize single-color-match accuracy and fast results. Primary markets include laboratories, healthcare providers, food service establishments, and educational institutions. The company maintains quality certifications and FDA listing for select products.

Schivo is a vertically integrated contract manufacturer specializing in high-quality medical device components, sub-assemblies, and final assemblies for minimally invasive surgical systems, robotic-assisted surgical platforms, cardiovascular and neurovascular devices, and orthopedic implants. The company operates globally with best-practice manufacturing facilities and applies design-for-manufacturability principles to optimize cost, productivity, and time-to-market for OEM partners. Schivo's AFP division manufactures ultra-reliable fluid control components and sub-assemblies for laboratory chromatography instruments, genomic analysis systems, and clinical diagnostic platforms. The company provides full contract manufacturing services including new product introduction (NPI) with early-stage design-to-manufacturing integration, process qualification and validation using ISO-qualified methodologies, and comprehensive regulatory support for FDA submissions. All manufacturing processes are tracked and documented through the company's manufacturing management platform. Schivo is FDA-registered and complies with FDA quality system requirements and ISO standards. The company serves global medical device OEMs across surgical, diagnostic, and life science markets, offering value-added services that extend beyond component manufacturing to include design optimization, risk mitigation, and supply chain integration.

EQUASHIELD LLC is a global medical device manufacturer specializing in closed-system transfer devices (CSTDs) and pharmacy automation solutions for safe handling of hazardous drugs. Founded in 2009 and headquartered in Port Washington, New York, the company serves hospitals, pharmacies, oncology centers, and cell/gene therapy facilities across more than 25 countries. EQUASHIELD is recognized as the #1 CSTD in U.S. pharmacies for seven consecutive years. The company offers a comprehensive portfolio including manual CSTD products for preparation and administration, automated compounding platforms (Mundus HD for general oncology, Mundus Neo for neonatal/pediatric precision dosing), and CellShield solutions for cell/gene therapy manufacturing. All products are CE-marked and FDA-cleared, supported by clinical evidence. EQUASHIELD emphasizes worker protection, contamination prevention, and dosing accuracy through proprietary pressure equalization technology. The company provides 24/7 clinical support, comprehensive training via EQ Academy, and full process traceability with EMR integration capabilities.

KSL Diagnostics is a national reference laboratory headquartered outside Buffalo, New York, specializing in CLIA-certified and CAP-accredited cytogenetic diagnostic testing. The company focuses on comprehensive chromosome abnormality analysis for oncology and acquired genetic disorders, serving pathologists and clinicians across the United States. KSL Diagnostics operates a state-of-the-art facility with a team of highly qualified clinical professionals possessing over 75 years of combined clinical service experience. The organization employs a consultative approach to guide physicians through a comprehensive testing menu, supporting precision medicine initiatives and improved patient outcomes. Strategic partnerships, including affiliation with University at Buffalo and Thermo Fisher Scientific, enhance KSL's diagnostic capabilities and service offerings. The company's core competencies include cytogenetic analysis, chromosome disorder diagnosis, and reference laboratory services. Leadership is composed of industry experts committed to quality assurance, customer service, and solutions-driven laboratory operations. KSL Diagnostics operates under three guiding principles: Excellence, Innovation, and Growth.

Life Data Lab, LLC is a healthcare software company developing Laboratory Information Management Systems (LIMS) and clinical data integration platforms. The company's flagship product, VIVICA, is a cloud-based LIMS designed to centralize and streamline laboratory and medical data workflows for doctors, patients, and laboratories. VIVICA offers user-friendly information management, integrates data across multiple healthcare databases, and facilitates secure communication between healthcare providers and patients to support faster, more informed clinical decision-making. The platform is positioned as insurance-covered and cost-effective for laboratories seeking to optimize operational logistics and data analytics. Life Data Lab is led by a leadership team with extensive experience in life sciences, medical diagnostics, enterprise software, and international healthcare operations. The company's vision centers on improving healthcare technology through data analysis, with an ambitious goal of analyzing data from at least ten million patients to drive technological advancement. The platform emphasizes prompt communication, seamless integration between disparate systems, and practical service delivery to support accurate and timely laboratory results. VIVICA is designed to meet the needs of healthcare providers requiring functional, user-friendly, and cost-efficient systems for managing medical records and facilitating collaboration across care teams.

The Phantom Laboratory manufactures high-precision phantoms and custom solutions for medical imaging and radiation therapy quality assurance and research since 1989. The company specializes in CT, MR, and mammography phantoms, including flagship products such as Catphan® 600 for diagnostic CT QA and ACTM phantoms for evaluating automatic tube current modulation performance. Working with renowned medical physicists, The Phantom Laboratory develops patented designs and continues to advance products that support evolving imaging technologies. The company also offers OEM and fully custom phantom solutions tailored to specific testing, calibration, and research requirements for imaging facilities, manufacturers, and research institutions.

ARX Sciences is a specialized manufacturer and distributor of in vitro diagnostic reagents and biologicals based in Buffalo, New York. The company manufactures coagulation controls, microbiological transport media, and markets validated antibodies and recombinant proteins for research and clinical diagnostics. ARX operates cGMP-certified, ISO 13485-compliant, FDA-registered manufacturing facilities offering custom formulation development, contract manufacturing with flexible lot sizes, and proprietary formulation support. Core product lines include primary and secondary antibodies for ELISA, Western blot, immunohistochemistry, immunoprecipitation, and immunofluorescence applications; recombinant proteins such as human growth hormone; and EUA-authorized viral and bacterial transport media for specimen collection and preservation. The company provides end-to-end transparency in custom manufacturing, rapid turnaround (4–8 weeks), and integrated quality testing for diagnostic assay development and production.

Seroclinix is a diagnostic testing company offering analyzer-based quantitative urinalysis solutions and at-home laboratory testing services. The company provides fully-automated in-clinic chemistry analyzers with reagent test solutions as upgrades from conventional urinalysis test strips, delivering more reliable and informative results. For at-home blood sample collection, Seroclinix employs state-of-the-art technologies including VAMS® (volumetric absorptive microsampling) and LC-MS (liquid chromatography–mass spectrometry) for sample collection and laboratory analysis. The platform enables both in-clinic and at-home sample collection, with integrated user interfaces, sample shipping, processing, and result reporting systems. Seroclinix serves both human healthcare and veterinary markets, emphasizing patient engagement, compliance, and operational efficiency. The company focuses on removing barriers to frequent, proactive testing through micro-sampling kits designed for home use. Markets include primary care clinics, veterinary practices, and telehealth providers. Products are positioned for specialized diagnostic testing across multiple patient populations.

Chembio Diagnostics, Inc. is a leading developer and manufacturer of rapid point-of-care (POC) diagnostic tests for infectious diseases, headquartered in Hauppauge, New York, with operations in Medford, New York. The company specializes in innovative diagnostic solutions utilizing its proprietary Dual Path Platform (DPP®) technology, which delivers improved sensitivity, multiplexing capabilities, and rapid results from a small sample of fingertip blood. Chembio's product portfolio includes FDA-approved and CLIA-waived assays for HIV, syphilis, Hepatitis C, COVID-19, and emerging infectious disease detection. The company also develops quantitative diagnostics (FastPack® hCG) and is actively advancing diagnostics for typhoid fever and preeclampsia. With 337 employees and approximately $55.3 million in annual revenue, Chembio markets its solutions to medical laboratories, hospitals, government health agencies, NGOs, and retail establishments across the United States and internationally. The company is committed to delivering exceptional, easy-to-use, fast, and accurate diagnostic solutions to enhance health outcomes in infectious disease detection and monitoring.

Polymedco is a B2B medical diagnostics company specializing in early detection and screening solutions for life-threatening diseases. The company develops and markets two primary product lines: OC-Auto® FIT, an automated fecal immunochemical test for colorectal cancer screening, and PATHFAST® Cardiac Biomarker Analyzer, a point-of-care (POC) cardiac testing platform. OC-Auto FIT is marketed as the number-one automated noninvasive CRC screening tool globally, carrying a Tier 1 US Preventive Services Task Force guideline recommendation, and has demonstrated clinical evidence of improving patient compliance (43.8% increase), reducing annual CRC incidence (25.5% reduction), and reducing cancer mortality (52.4% reduction). The PATHFAST analyzer performs lab-quality cardiac biomarker testing from a single whole blood sample, delivering results in minutes with measurements of Troponin I, NTproBNP, D-Dimer, hsCRP, CK-MB, and Myoglobin. Both systems are designed for integration into healthcare systems, reference laboratories, and point-of-care settings. Polymedco emphasizes customer-centric support, offering customizable programmatic solutions, technical implementation support, and LIS (Laboratory Information System) integration. The company partners with healthcare systems, payors, providers, and reference laboratories to improve screening accessibility and affordability. Products feature robust clinical evidence and user-friendly design for high-volume, cost-effective screening and diagnostic workflows.