GHP Q3 2021

12 GHP / Q3 2021 , of a DCIS test, PreludeDx used the findings from multiple studies totaling nearly 3,000 women to create the non-linear risk algorithm that exists at the heart of DCISionRT test results. Suitable for testing on both presurgical biopsies and surgical specimens, the combination of the data acquired for the nonlinear algorithm with DCISionRT’s sophisticated AI and machine learning capabilities are well suited for intricate biological disease processes – far more so than traditional linear algorithms. DCISionRT is the only test of its kind to be validated with Level 1B Clinical Evidence, which verifies consistent results across multiple studies, including a randomized clinical trial. The studies were carried out in medical and research centers and hospitals across the globe, with the SweDCIS randomized clinical trial in Sweden taking on landmark independent clinical validation of DCISionRT. The trial found that patients with low Decision Scores received no significant invasive risk reduction from radiation therapy after surgery, whereas patients with elevated Decision Scores showed a 9% reduction in invasive risk. The study concluded that DCISionRT—for the first time in the history of DCIS treatment— enables physicians to predict the extent to which patients would benefit from radiation therapy. The effects of these findings were substantial, not just for the relief of pressure on patients and healthcare providers, but in the short-term too. The results of the DCISionRT studies allowed for triage and prioritization of patients for surgery based on actual biological urgency at the height of the COVID-19 pandemic. Second Opinion from Expert Breast Pathologist As a hub of expertise for breast cancer treatment and care, PreludeDx also offers its knowledge base and resources to patients via Breast SOS™, a second opinion service to help patients better understand their diagnosis through expert verification and—if required— amendment. The specialized clinic, led by world renowned breast pathologist, David J. Dabbs, MD, is designed to offer patients secondary insight from the third-party perspective of a healthcare professional. A second opinion is recommended for a myriad of reasons, including uncertain or unusual circumstances surrounding a diagnosis, the patient having concerns or questions, a health insurance plan requiring it before approving a particular treatment, or for planning further treatment after surgery. Unfortunately, only 10-20% of patients have access to qualified individuals with the nuanced and specialist training in breast pathology required to make an informed and comprehensive recommendation. Every patient should have the right and the ability to access a second opinion. Without it, onesided diagnoses risk inaccuracies that can lead to unnecessary clinical interventions, extraneous costs, and increased anxiety for patients and their families. Breast SOS grants patients confidence in their diagnosis and offers them all the information they will need to know in accessible literature and engaging discussion, acting as a trusted partner and source of support throughout the process. The People Behind the Innovation Patients and physician clients are able to trust in PreludeDx and have confidence in its team. The CLIA (Clinical Laboratory Improvement Amendments) covers approximately 260,000 laboratory entities and falls under regulation by the Centers for Medicare and Medicaid Services (CMS) for all laboratory testing performed on humans in the US. The Division of Clinical Laboratory Improvement & Quality—within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ)—has the responsibility for implementing the CLIA Program. CMS has granted the College of American Pathologists (CAP) Laboratory Accreditation Program deeming authority, which has enabled CAP inspection in lieu of CMS inspection. CAP has retained its deemed status with the Joint Commission, the United Network for Organ Sharing, the National Marrow Donor Program, the Foundation for the Accreditation of Cellular Therapies, among many US state agencies. PreludeDx’s team of highly-trained quality and compliance staff play an integral role in maintaining the standards of operations, staying abreast of the ever-evolving laws and regulations. Driving Innovation is, after all, one of the core values upon which PreludeDx was built, alongside Quality First, which guarantees the prioritization of quality systems, processes, and results, and Patient Focused, recognizing that behind each sample is a patient who deserves respect and conscientious treatment. PreludeDx exists to serve the needs of its patients, and as such, is committed to handling each sample with care and providing