Company Profile Hy Laboratories Ltd. (hylabs) is Israel’s leading developer, manufacturer and distributor of tools for detection and identification of microorganisms and molecular biology products. hylabs provides a full range of products and services to the healthcare, industrial, environmental and research markets. Proven product quality, reliability and exceptional service have set the industry standard since 1974. Highly experienced R&D staff work closely with leading microbiologists, molecular biologists and researchers to assess needs and advance to future technologies and new product developments. A fully trained internal quality assurance unit monitors all testing to ensure accuracy, reliability and timeliness. A professional customer service and support team offers technical and on site assistance. On 2011 hylabs acquired all the exclusive proprietary rights for the placental protein 13 (PP13) and its immunodiagnostic kit manufacturing to predict preeclampsia. Manufacturing Facility Hy Laboratories is a fully licensed, FDA registered manufacturing facility, offering a full array of tools and products in both the microbiology and molecular biology markets. This includes culture media, biochemical and PCR/qPCR based kits for diagnostics, reagents, solutions and custom made preparations developed per customer specifications. World class, computerized facilities feature: Class 10,000 Clean Rooms with Class 100 Laminar Air Flow Hood (LAFH) ISO 9001 and ISO 13485 certified Customers value our consistent quality, on-time deliveries, well refined manufacturing procedures and cost efficiency in Israel and abroad. Microbiology Services This division serves a wide range of customers in the pharmaceutical, cell therapy, cosmetics, food and water, biotechnology, academic and medical devices industries. Specializing in microbiology and toxicity testing that meets international regulatory standards including the coveted ISO 17025 by the Israel Laboratory Accreditation Authority (ISRAC), GMP by the Israeli Ministry of Health and FDA approval for sterility testing. Services include Sterility Testing, Rapid Sterility Testing (BacT/ALERT), Determination of Bioburden on Products, Endotoxin Validation and Testing by LAL Method, Validation of bacterial contamination by the Gram stain method for the cell culture industry, Antimicrobial Preservation Efficacy Test, Microbial Limit, Test Package Integrity, Validation of Sterilization Process (Steam, ETO, Gamma Irradiation, Dry Heat, STERRAD, Cleaning validation, and Bacterial Identification. The lab operates a specially designed and engineered facility for the testing of Mycoplasma in cell lines and biotherapeutics. Our wide range of customers successfully submitted our documentation through regulatory agents such as the FDA, EMA, CE and Israeli Ministry of Health. Molecular Biology Services This division provides complete service solutions with an extensive portfolio of proteomic and genomic based tools. Projects are fully coordinated by highly skilled experts operating under GMP and ISO 9001 guidelines. Well-equipped laboratories offer custom DNA sequencing, genotyping services, bacterial and fungi identification by PCR and DNA sequencing, Mycoplasma nested-PCR detection according to Pharmocopoia guideline, as well as Cell Bank Characterization. Additional services include PCR, RT-PCR, cloning, Real-Time PCR, DNA/RNA extractions, genomic differentiation and bioinformatics analysis, custom oligo and peptide synthesis, custom gene synthesis and more.