Abbott Molecular (AM) is making the promise of personalized medicine a reality. As a leader in the field of molecular diagnostics, Abbott Molecular has been developing and commercializing successful products for more than 25 years. In 2001, AM's PathVysion was the first gene-based test (HER2 amplification) linked to a therapeutic Herceptin® (trastuzumab). Today, Abbott Molecular offers a broad range of technology and expertise to enable collaborative partnerships aimed at advancing the field and transforming patient care.
- Technology and Platform Capabilities: Abbott Molecular provides integrated services and custom assay development. Our technology platforms include instruments and assays for FISH (fluorescence in situ hybridization), sequencing, genetic analysis, real-time polymerase chain reaction (PCR) and are compliant with FDA cGMPs and global regulatory standards. AM's automated platforms are designed to provide consistent reproducibility and accuracy, system flexibility, and diverse testing menus that help address laboratory demands at every level.
- Regulatory Knowledge and Experience: Pharmaceutical and medical device manufacturers must coordinate all activities closely in developing a companion product in order to successfully navigate the challenges of companion product regulatory submissions. Abbott Molecular provides the regulatory expertise to guide discussions with regulatory agencies and to design clinical trials. This supports the EU CE mark, FDA 510(k) clearance, and FDA PMA approval processes.
- Established Partner Committed to Success: Abbott Molecular develops comprehensive, companion diagnostic strategies for the world's leading pharmaceutical, biological, and entrepreneurial companies. Over 300 scientists and engineers, along with dedicated resources in legal, health economic and outcomes research, medical affairs, clinical development, regulatory affairs, and marketing contribute to this core competency. Working in conjunction with Pharmaceutical partners, Abbott Molecular forms and executes co-commercialization strategies. These strategies encompass physician education, guideline adoption, laboratory awareness, and reimbursement. AM also stands ready to assist Pharma in establishing value-based pricing through comparative effectiveness research. These steps maximize market uptake of innovative companion products.