Medical and Scientific Affairs

There is a need to develop diagnostics and therapeutics that can make an impact in Alzheimer’s. Healthcare providers will utilize fluid biomarkers as part of the Alzheimer’s diagnostic workup, and laboratory professionals will play an essential role along the clinical care pathway.

Early detection of Alzheimer’s pathology can occur in vivo using fluid biomarkers and/or positron emission tomography (PET) imaging. The cerebrospinal fluid (CSF) ratios A𝛃42/A𝛃40 and pTau181/A𝛃42 are reflective of Alzheimer's pathology and correlate with PET. This program will also discuss CSF biomarkers laboratory implementation. 

In 2022, the American Diabetes Association released a Consensus Report on Heart Failure: An Underappreciated Complication of Diabetes and recommended at least yearly biomarker screening to identify patients with early stages of heart failure. This program will discuss the importance of biomarkers to identify more patients with undiagnosed heart failure.

About 6.2 million adults in the United States have heart failure (HF), and more than 900,000 new cases are diagnosed every year. The mortality rate for chronic HF is ~50% at 5 years post-diagnosis. HF costs the nation an estimated $30.7 billion in 2012, and a major contributor to these costs are hospitalizations. Acute HF patients are often under-treated and not on all available Guideline-Directed Medical Therapies (GDMT: ACEi/ARB/ARNi, MRA, BB, SGLT2i) or at low dose. Two major concerns for not prescribing full doses are patient safety and frailty. STRONG-HF was designed to assess the safety and efficacy of rapid up-titration of evidence-based GDMT and close follow-up (physical examination, NT-proBNP concentrations) compared to usual care and was terminated prematurely due to superior results in the intensive intervention arm in October 2022.

The prevalence of cancer in the U.S. population is 18.1 million and is projected to increase to 26 million by the year 2040. Currently 47% of the U.S. population has lived for at least 10 years since their cancer diagnosis, reflecting improvement in cancer survival and increase in life expectancy. However, cancer and cardiovascular (CV) disease are still the leading causes of death worldwide. When these two diseases occur together, the burden of CV disease and mortality in patients with cancer becomes substantial. There is a need to identify and monitor patients’ risk to mitigate events and facilitate cancer and CV management and treatment. This session will provide the viewer the current definition of cardiotoxicity and the potentially cardiotoxic cancer therapies, and the role of cardiac biomarkers throughout the patient journey.

Viral infections are common among patients admitted to hospitals with acute respiratory failure. As viral respiratory infections may be clinically and radiographically indiscernible from bacterial infections, the use of rapid viral respiratory diagnostics may have the potential to decrease inappropriate antibiotic use by increasing diagnostic certainty. In this session, we review the current respiratory season and data supporting the impact of rapid respiratory diagnostics on antimicrobial stewardship efforts.

The pandemic has brought about an opportunity to perform diagnostic testing in new ways. Solutions, such as devices for remote patient monitoring, over-the-counter tests and collection of samples in patients’ homes have changed the workflow of traditional laboratory testing. Along with opportunity, however, there are also challenges that must be addressed. This session will discuss the different ways that testing has evolved, the impact to the clinical laboratory and the future of diagnostics in the continuum of care.

This educational presentation includes audience response questions and patient case scenarios designed to provide insight and improve audience knowledge regarding the clinical, economic and/or stewardship impact of using rapid diagnostics for blood culture identification with a specific focus on how these instruments improve outcomes.

One of the goals of the U.S. Ending the HIV Epidemic (EHE) initiative is to have 50% of people who could benefit from PrEP (pre-exposure prophylaxis) using it by 2030. Routinely used diagnostic tests fail to detect early infection, leading to adverse health outcomes. Based on this new evidence, the CDC updated the PrEP guidelines to include testing with antigen/antibody (Ag/Ab) and Nucleic Acid Amplification Test at every PrEP monitoring visit.

Elimination of HCV transmission will require a collective effort, starting with awareness, appropriate and effective screening and diagnostic testing practices. Despite great strides in the treatment of HCV with direct-acting antivirals, the burden of HCV remains high in the U.S. and globally. This presentation will include a brief overview of the patient journey of HCV infections in the U.S., highlight some of the challenges with HCV patient management and discuss the importance of early and effective diagnosis and linkage to care.
 

Digital PCR has proven its utility in the precise detection of low-abundance mutations, indicating its value not only in early diagnosis but also as a powerful tool to guide informative treatment decisions. Here, we will review the principle of digital PCR and its applications across the cancer care continuum.

Precision oncology, using comprehensive genomic profiling (CGP), has the potential to significantly improve cancer care. Identifying specific genetic changes in a cancer can match patients with treatments. This session is meant to educate the viewer on the need for CGP and how it provides deeper insights into therapy choices.

Biomarker testing has become part of the diagnostic landscape in breast cancer and is required to identify appropriate treatment and prognosis for patients. Due to the essential nature of these tests, specimen handling is of the utmost importance to ensure reliable and valid results.

In 2022, lung cancer was the second most common cancer diagnosed and responsible for the most deaths. Identification of actionable biomarkers in NSCLC has redefined the therapeutic landscape. The session aims to educate on the characteristics, diagnosis, biomarker testing and treatment implications of lung cancer.

Human papillomavirus (HPV) is known to cause over 93% of cervical cancer. Early diagnosis and treatment, as well as vaccines, could eliminate this cancer. This presentation will discuss cervical cancer screening and management guidelines and provide an overview of different methods for screening and triage of patients.

Breast cancer affects 1 in 8 women in the U.S., with only a 30% rate of 5-year survival for metastatic patients. Breast cancers that have human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) scores of 1+ or 2+ with negative in-situ hybridization (ISH) represent around 50% of breast cancers. The aim of this session is to enable laboratories to meet the needs of their clinicians by properly segmenting patients with low-level expression of HER2 and its implications for clinical lab professionals and patients.