Coronavirus Services

Genway is now offering several coronavirus catalog products available for purchase. In addition, we are happy to assist with any custom project, including CLIA and ISO13485 services.

Genway's Clinical Laboratory Services offer reliable pre-clinical study and clinical trial testing to support companion diagnostic development, a PMA submission, or a 510(k) submission. Genway works with your clinical, scientific, and regulatory personnel to define study objectives and specifications. Based on your needs, we provide a project budget and a timeline with including milestone deliverables. At each milestone scheduled, we provide a progress report based on your specifications.

Genway maintains ISO13485 accreditation for the development, validation, and production of antibodies and proteins for use in FDA regulated or CE mark products. Genway has developed and manufactured antigens and antibodies for use in IVD's and also for assays used in development or testing of pharmaceutical and biotech products. Under the Genway Quality System we work with clients in design control, development, validation, production, and testing of antibodies and proteins.