The Diagnostic Landscape will deliver the most comprehensive and customized understanding of the specific testing market into which your company is planning to launch your targeted therapy and associated diagnostic test. By turning over every stone, we will identify the most significant risks and opportunities the team can expect to face and help you prepare to address each anticipated hurdle so that the test effectively enables the therapy for the right patients.
Diaceutics always begins the landscape analysis breaking down the patient journey, with a specific focus on the diagnostic. We recognize that the diagnostic experience for patients is often closer to an odyssey than a journey; beginning with clinical presentation through treatment decisions, the diagnostic intervention opportunities and testing stages can often be inefficient, presenting opportunities for patients to be missed to therapy. Understanding this can enhance the prescribing reach of a targeted therapy based on filling those gaps throughout the patient journey.
Diaceutics can help you understand the laboratory landscape, testing volumes, testing rates and test methodologies, all of which are critical for seamless access to testing. The Lab Mapping analysis will identify the key labs, within virtually any target market, that are already (or will likely be) conducting the diagnostic testing relevant to your therapy. This can inform specific tactical and investment decisions as you prepare for commercialization.
Diaceutics works with pharmaceutical and diagnostic companies to help seamlessly achieve diagnostic test access by providing a clear understanding of global processes and challenges in test pricing and reimbursement. Appreciating how some tests may be reimbursed based on the technology used rather than how a diagnostic company chooses to price their particular diagnostic kit can highlight a significant issue that can affect how patients ultimately get tested.
We help our customers navigate through complex regulatory frameworks related to diagnostic testing in the development, commercialization and post-commercialization phases. Our experts are constantly monitoring these dynamic changes as they are introduced by governmental regulators around the world. The path to regulatory approval for a test associated with a specific therapy must be effectively planned to ensure the test is available in time when the product is approved by the regulators.
Laboratory turnaround time is measured from the time the sample arrives at the molecular pathology laboratory until the result is reported back to the physician. Total turnaround time is measured from the time the sample is taken from the patient until the result is reported. While turnaround time can vary in different countries and for different tests, Diaceutics uncovers where these times can be optimized so that results are ready in a timely fashion to drive accurate prescribing to get the right drug to the right patient at the right time.
Diaceutics recognizes that the availability and management of tissue samples for performing routine testing, including testing of a specific biomarker, is crucial. Our laboratory experts help our pharma partners understand and quantify the current sample usage requirements and where there might be potential problems with how these samples are acquired and utilized throughout the testing process.