List of Immuno-Assays Companies in California - 31

Cells are the basic unit of life. They power everything we do, and unlocking their secrets is the key to advancing our knowledge of every facet of biology, from development to disease. Our single cell, spatial, and in situ tools enable researchers to answer pressing questions about cells and their functional contributions to oncology, immunology, neuroscience, and much more—as evidenced by more than 5,500 publications citing our technology. We are dedicated to building the best products, delivering the best customer experience, and creating the best team to fuel new scientific discovery, no matter how challenging. And we won’t stop until all of the cells’ secrets are revealed.

Abterra Biosciences is reimagining antibody discovery and sequencing by harnessing the latest next-generation sequencing, mass spec, machine learning. Abterra Biosciences is enabling the next-generation of antibody therapeutics. Our technologies use the latest in next-generation sequencing.

ACON Laboratories is an international diagnostic and medical device company with our corporate headquarters in San Diego, California USA. For more than 15 years, ACON has led the way in making high quality diagnostic and medical devices more affordable to people all around the world. The ACON name is well known in over 130 countries. Headquartered in San Diego, California, the US office is the center of strategic management, administration, business development, innovative research and development. Our state of the art manufacturing facility is ISO 13485:2003 certified, FDA registered and has been inspected by US FDA. Our current product lines include Diabetes Care, Clinical Chemistry (including Urinalysis and Point of Care Tests) and Immunoassay EIA/ELISA. We also have a number of new products in the pipeline for introduction in the future.

ARK Diagnostics Inc. designs, manufactures, and distributes in vitro diagnostic products. ARK's proprietary assays accurately measure drug levels in biological fluids. Clinicians use these measurements to guide dosing decisions for safe, effective, and personalized drug therapy. By optimizing drug levels, clinicians improve outcomes, reduce toxicity, and lower healthcare costs. ARK is dedicated to improving the quality of patient health through better therapeutic drug management. (ARK Diagnostics, Inc. seeks regulatory clearance in the United States and Internationally.)

BioCheck develops and manufactures high-quality immunoassay kits for the worldwide healthcare markets in their cGMP and ISO 13485 certified facility in the San Francisco Bay Area. BioCheck also provides custom immunoassay development and contract manufacturing services to the diagnostic and research industries.

BioLegend develops antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA.

Correlia Biosystems develops innovative microscale tools that accelerate the rate of molecular interactions for rapid measurements of biomolecules. The customizable PIXI​ platform opens up new biological questions for interrogation from less than two microliters of sample, with rapid results that allow for dynamic monitoring of protein expression profiles.

Diazyme uses its proprietary enzyme technologies to develop diagnostic reagents which can be used on most automated chemistry analyzers in user-friendly formats. Diazyme's products include test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes.Diazyme DZ-LITE SARS-CoV-2 IgG, IgM CLIA Kits

Epinex Diagnostics is a medical device company that specializes in the development of innovative rapid tests that target major deficiencies in existing healthcare markets. Our proprietary platform for rapid tests uses existing technologies to create unique quantitative diagnostic tests for the point-of-care (POC) and over-the-counter (OTC) markets. The Company’s flagship product is the G1A™ Rapid Diabetes Monitoring Index Test, a patented monthly test for diabetes monitoring. The Test has the potential to improve diabetes care and have a successful impact on the current worldwide diabetes epidemic, the most significant chronic disease affecting the world today. Epinex Diagnostics, Inc. is located in Tustin, California, adjacent to the University of California, Irvine, in the heart of the Southern California biomedical industry.

Genalyte is a tech-enabled, full service CAP accredited and CLIA certified laboratory. We perform the majority of tests with our rapidly deployable mobile laboratory in under 30 minutes. Our central lab handles tests that cannot be performed onsite. All results are run through CloudLab, our proprietary tele-health platform, for quality oversight and monitoring by Clinical Lab Scientists. Core to our mobile capabilities is the Maverick platform, which has unprecedented serological testing functionality - permitting up to 64 simultaneous immunoassays on whole blood in 15 minutes. The platform achieved FDA clearance in Oct 2019. In these unprecedented times, we have developed a rapid COVID-19 serology test for IgG and IgM antibodies, while simultaneously including flu and other respiratory illnesses for differential diagnosis. For more information, visit www.genalyte.com.

GigaMune is a therapeutics company developing a novel technology for in vivo, T cell targeted gene delivery of T cell receptors (TCRs) and chimeric antigen receptors (CARs) for serious diseases such as cancer and autoimmune diseases. Our initial goal is to challenge conventional ex vivo cell therapy manufacturing by reducing costs and improving outcomes. Our eventual goal is to deliver any gene to any cell in any tissue location at any time. See our high throughput immune screening technology highlighted in Nature Biotechnology (DOI: 10.1038/s41587-020-0438-y), and our petabase-scale protein search algorithm, published in Nature (DOI: 10.1038/s41586-021-04332-2).

ImmunoScape is a pre-clinical biotechnology company focused on the discovery and development of next-generation TCR cell therapies in the field of oncology. The company's proprietary Deep Immunomics technology platform enables highly sensitive, large-scale mining and immune profiling of T cells in cancer patient samples to identify novel, therapeutically relevant TCRs across multiple types of solid tumors. ImmunoScape has multiple discovery programs ongoing and will be progressing towards IND-enabling studies and entry into the clinic. To learn more, visit us at immunoscape.com and follow us on Twitter @immunoscape.

IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, we focus on critical life threatening diseases such as COVID-19, HIV/AIDs, lung cancer, breast cancer, bladder cancer, HPV/cervical cancer, head and neck cancer, ovarian cancer, hepatitis, and organ transplant infections. Our proprietary diagnostic method provides specific molecular details about each and every cell. This technology now made available through IncellDx, is capable of revolutionizing the field of molecular diagnostics, one cell at a time.

JAJ International, Inc is a worldwide leading company in the rapid one-step diagnostic industry. Founded in 1998, our scientists have developed extraordinary lines of products, many of which hold unique patents. JAJ International develops, manufactures, and markets a wide array of one-step diagnostic test kit, including Cardio markers, Infectious diseases, Drug abuse, Sexually transmitted diseases, Pregnancy and Fertility etc. Pioneered in technological breakthroughs, JAJ is the first, and in many cases the only, company who can achieve rapid tests of equal or better quality than the equivalence in Elisa tests. After many years of Research and Development and many technological breakthroughs, JAJ International is poised to take a leadership position in the Rapid Diagnostic Market.

Marin Biologic blends the fields of cell biology, immunology, molecular biology and biochemistry to tackle complex projects in an innovative and timely manner. We simultaneously utilize our in-depth scientific expertise to collectively approach projects to complement our client’s approach and meet the client’s needs. Marin Biologic is a woman PhD owned and managed Contract Research Laboratory which specializes in the research, pre-clinical and clinical development and validation of cell based assays and immunoassays for biotech and pharmaceutical companies in Phase I/II or Phase III stages. Our unique approach to collaboration encourages scientists to talk to scientists to create better science. We are compliant with U.S. FDA cGMP/GLP standards as well as ICH for all levels of clinical development. We employ these standards that are phase appropriate for your clinical development or research. CEO and President Tania Weiss PhD founded Marin Biologic Laboratories in 1995 to be able to apply her enthusiasm for good scientific process to a broad array of client projects. As a result, the client list as well as the project list is very diverse over the history of the Company. Marin Biologic seeks out and attracts interesting and different scientific opportunities, which puts them at the forefront of scientific development. Our Lab is located in Novato, California, halfway between San Francisco and the Napa and Sonoma Valleys. Peter Ralph. PhD, VP Science, peter@marinbio.com Tania Weiss, PhD, CEO, tania@marinbio.com 415 883-8000 Visit: www.marinbio.com to connect with us, or ask us a question.

MiLaboratorydevelopsbioinformatics solutions for adaptive immunity analysis.

Molecular Depot is a biochemical company located in San Diego, California that specializes in developing research tools such as Specialty Bacterial Culture Media, Antibodies & Antigens, Enzymes & Proteins, Chemical Compounds & Molecular Conjugates, Research Kits, Reagent Stabilization Solutions. They also provide consulting and research services related to their products.

Nexus Dx is a global provider of Near Patient Testing systems and advanced diagnostic solutions. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. Company Highlights: Primary focus on expansion of assay systems in the Near Patient Testing industry Multi-product revenue generating business Proprietary technologies and content Highly experienced management team Nexus Dx Inc.

Novodiax is a biotech startup dedicated to advancing cancer and autoimmunity diagnostics through innovative rapid immunoassays. Our revolutionary ihcDirect® assays are listed for in vitro diagnostic (IVD) use and provide immunohistochemistry (IHC) results in as little as 10 minutes on frozen tissues! They also provide workflow benefits for formalin-fixed, paraffin-embedded (FFPE) tissues, helping reduce assay time by up to 40-60 minutes. ihcDirect works by directly conjugating primary antibodies to our proprietary and sensitive polymerized horseradish peroxidase (polyHRP) detection system, thus delivering immunoassays for histology and cytology (2020) that: - Are lightning fast (~10 minutes) - Require minimal lab space and no specialized equipment - Can be performed at room temperature - Are simple to perform like H&E tests, yet provide the sensitivity and specificity of immunoassays Our assays are also perfect for helping you advance your research (see our ihcPrime™ and Q-Stain® products and custom services), develop cutting edge companion diagnostics (CDx), and more. Let's partner together to make that happen! Visit our website or contact us to learn more. www.novodiax.com sales@novodiax.com

OKRA Care is highly committed to providing hospital-grade glucose monitoring test kits to help patients manage diabetes effectively

As part of Thermo Fisher Scientific, we develop and manufacture products and offer services to advance the science of transplant diagnostics. Our solutions and services help transplant labs and clinical teams provide personalized care across the patient experience. Dr. Paul Terasaki founded One Lambda™ in 1984 with the goal of developing tests to improve how laboratories match and monitor transplant recipients and donors. Since then, our HLA typing and antibody detection assays have been trusted by transplant laboratories worldwide. Clinicians also rely on data from our patient monitoring tests to make important decisions about post-transplant therapies. Transplantation is life-changing for recipients, and clinical diagnostics play a vital role in supporting all phases of treatment. Through our commitment to scientific innovation, product quality, patient advocacy, and excellent customer service, we are helping the transplant community raise the standard of care and improve outcomes for patients and their families. To find out how you can join our team, visit jobs.thermofisher.com.

Contract R & D

Personalis, Inc. operates as a cancer genomics company worldwide. The company provides sequencing and data analysis services to support the development of cancer therapies. It offers NeXT Platform, which provides data for cancer therapy development, personalized therapies, therapy selection, and diagnostics. The company also provides a complementary liquid biopsy assay that analyzes various human genes versus. It serves biopharmaceutical customers, universities and non-profits, diagnostics companies, and government entities. The company has partnership with Berry Genomics; Natera, Inc.; and MapKure, LLC. Personalis, Inc. was founded in 2011 and is headquartered in Menlo Park, California.

Service company providingdrug discovery assay platforms that build upon our extensive experience in single cell analysis and multiplexing.

ProciseDx is helping patients leave appointments with answers instead of just another appointment. Our point-of-care diagnostic solutions are enabling faster decisions for patients and physicians.

Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. The company is dedicated to developing novel therapeutics for the treatment of cancer and infectious diseases.

QuidelOrtho develops and manufactures intelligent solutions that are transforming data into understanding and action for more people in more places every day, helping spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence. Together, we are advancing diagnostics to power a healthier future.

In vitro diagnostic company, specializing in the production of antibodies, controls, blockers including HBR. - Clean Rooms - Filling - Finishing - Packaging - Sub-Assembly - Inventory Space - Kit Manufacturing - Lyophilization - Antibody Production - Medical Device Manufacturing

Takara Bio USA, Inc. (formerly Clontech Laboratories, Inc.), a Takara Bio company, develops, manufactures, and distributes a wide range of life science reagents under the Takara®, Cellartis®, and Clontech® brands. Our products support applications including stem cell research; NGS; gene discovery, regulation, and function studies; protein expression and purification; RNAi and gene editing; and plant and food research.

Truvian is a transformational diagnostic company bringing lab-accurate results to the point-of-action where consumers engage healthcare providers to lead healthier lives. With a focus on making routine blood testing accessible, convenient, and transparent, Truvian is accelerating the transition to a sustainable healthcare ecosystem through its comprehensive benchtop solution that delivers timely, actionable results to help stop disease before it starts.

United Immunoassay provides top quality raw materials to the IVD industry.