b'I N T R O D U C T I O NCompanionDiagnostic TestingAccording to the U.S. FDA definition, a companion diagnostic is a medical device, oftenan in vitro device (IVD), which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The use of a companion diagnostic will therefore help clinicians and healthcare providers determine whether a patient is likely to benefit from the drug in question and monitor the response. In the European Union under the new IVDR, the definition of a companion diagnostic expands to require patient screening before and/or during treatment for those likely to experience benefit and/or increased risk as a result of treatment with the corresponding medicinal products.The use of assays that have not been specifically validated for the safety and effectivenessof a drug or biological product may deliver inaccurate results that could harm the patient.For instance, a false positive result could lead to treatment with a drug without the proven benefits, exposing the patient to potential toxic side effects. Likewise, a false negative testresult could withhold or delay a potentially beneficial treatment, putting the patient at risk.Companion diagnostics help demonstrate drug efficacy and accelerate approval. They have become an important tool for improving individual patient treatment.LabPMM embraces international harmonization and partnering. We work with key opinion leaders to standardize molecular diagnostic testing and we are also partnered with pharmaceutical companies to develop companion diagnostic tests. Our proud historyof partnerships have led to outstanding work towards internationally standardized testing, exeplified by FDA and PMDA approval of the first companion diagnostic for acute myeloid leukemia. COMPANION DIAGNOSTIC TESTING LabPMM Services Catalog 2021|11'