Learn about IVD and laboratory-developed
test implementation in clinical laboratories
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Paper 1: An introduction to diagnostic testing
Paper 2: Preparing for and implementing a laboratory-developed test
Explore additional educational resources:
Webinar Series: Demystifying the Development and Implementation of Molecular Tests in a Clinical Laboratory
Explore the benefits and challenges of bringing an in-house molecular test to market, with real-world examples. In this webinar series, we aim to dispel common misconceptions of laboratory developed tests (LDTs) by inviting industry experts to share about the advantages, design and implementation process, and establishment of LDTs in clinical laboratories.
Using molecular panels to help manage infectious disease: update on lab trends and health outcomes
Learn about the different testing methods used by laboratory managers and the advantages of molecular techniques in areas including respiratory, gastrointestinal, and genitourinary conditions to improve overall outcomes.
Introduction to Diagnostic Test Reimbursement in the U.S
Before a clinical laboratory launches a molecular test, the question of how to receive payment for the test should be carefully analyzed. In this paper, learn about the designated CPT code types required for payment, which are used to bill for reimbursement. These codes are crucial for coverage and payment from all payers.
Regulatory Guidance for Labs that Design and Implement Diagnostic Tests
Understanding the regulatory environment for diagnostic tests is critical to the successful creation and launch of all diagnostic tests—in-vitro diagnostics (IVDs) and laboratory developed tests (LDTs). In this paper, learn about the role of various government agencies in regulating IVDs and LDTs and laboratory processes associated with diagnostic tests, and read about regulations related to IVD tests used for Research Use Only (RUO) and Investigational Use Only (IUO).