b'Companion Diagnostic TestingAccording to the U.S. FDA definition, a companionexposing the patient to potential toxic side effects.diagnostic is a medical device, often an in vitro device(IVD), which provides information that is essential for theLikewise, a false negative test result could withhold or delay safe and effective use of a corresponding drug or biologicala potentially beneficial treatment, putting the patient at risk.product. The use of a companion diagnostic will thereforeCompanion diagnostics help demonstrate drug efficacy help clinicians and healthcare providers determine whetherand accelerate approval. They have become an important a patient is likely to benefit from the drug in question andtool for improving individual patient treatment.monitor the response. In the European Union under the new IVDR, the definition of a companion diagnostic expands toLabPMM embraces international harmonization and require patient screening before and/or during treatmentpartnering. We work with key opinion leaders to standardize for those likely to experience benefit and/or increased riskmolecular diagnostic testing and we are also partnered as a result of treatment with the corresponding medicinalwith pharmaceutical companies to develop companion products. diagnostic tests. Our proud history of partnerships have led The use of assays that have not been specifically validatedto outstanding work towards internationally standardized for the safety and effectiveness of a drug or biologicaltesting, exeplified by FDA and PMDA approval of the first product may deliver inaccurate results that could harm companion diagnostic for acute myeloid leukemia. the patient. For instance, a false positive result could leadto treatment with a drug without the proven benefits, 12 LabPMM Services Catalog 2020|13'