Inside the Lab

While the rapid evolution of I-O continues to bring unprecedented change to the way cancer is treated, there are significant gaps impacting the laboratory team regarding the examination of resection specimens following neoadjuvant immunotherapy and staying abreast of advances in I-O biomarker testing. 

This episode discusses advances in I-O biomarker testing, advantages and limitations of some key I-O biomarkers, and practical ways that pathologists and laboratory professionals can improve their I-O biomarker testing workflows to optimize patient care. 

Topics discussed include: 

• Recent advances in immune-oncology (I-O) biomarker testing 
• Advantages and limitations of IO biomarkers 
• Addressing challenges related to IO biomarkers 
• Improving IO biomarker workflows 
• Best practices for collaboration with the multidisciplinary cancer care team 

The diagnostic paradigm for Alzheimer's disease (AD) has rapidly shifted in the last five years as fluid-based biomarker testing has emerged as a reliable, accurate, and accessible means to detect amyloid pathology when evaluating a patient for cognitive decline. This podcast is designed to help pathologists and laboratory professionals gain an understanding of plasma testing for markers such as Abeta40/42, P-tau181, and P-tau217 which are rapidly appearing in the commercial space and how healthcare providers have begun incorporating these tests into routine neurology practice. This podcast will help participants to understand the advantages and limitations of these assays as well as their potential application when a physician is evaluating a patient for AD. 

Communicating imperative diagnoses effectively can often be a daunting challenge. It’s a crucial and delicate step that takes practice and know-how to do well and can be one of the most important actions taken with patients. That’s why a panel of experts have gotten together to discuss the current practices, gaps, and best practices for communication of urgent and significant/unexpected diagnoses in anatomic pathology.

The Promoting Diagnostic Excellence by Improving the Communication of Urgent and Unexpected Diagnoses in Anatomic Pathology podcast is designed to support the collaboration with clinical partners as well as to notice actionable opportunities where the communication of urgent and significant/unexpected diagnoses in anatomic pathology may be improved.

You will learn to:

• Understand current guidelines and practices for communication of urgent and unexpected diagnosis in anatomic pathology. 
• Discuss high-priority communication barriers.
• Discuss best practices and recommendations for effective and timely communication of urgent and significant/unexpected diagnoses. 

Women make up a majority of the workforce in pathology yet lag behind men in leadership roles. What are the consequences of this for women working in pathology today, and what can be done? 

In this episode of Inside the Lab, Drs. Melissa Upton and Kimberly Sanford share a warm conversation in which they reflect on their long and varied careers, describe the unique challenges they faced over their careers, and discuss their accomplishments as trailblazers themselves. Our guests describe the value of finding mentors,  They also describe the opportunities for the future of pathology, particularly in the context of working in a multigenerational workforce with evolving expectations of workplace culture.

Although molecular testing offers promising opportunities for diagnosis and targeted treatment of cancers, prostate cancer has lagged behind other types of cancer. Recently, homologous recombination repair testing in prostate cancer has provided a means to achieving targeted treatments for patients as well as opening new avenues of collaboration between pathologists and oncologists.

On this episode of Inside the Lab, hosts Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP are joined by Heather Cheng, a medical oncologist and associate professor of hematology and oncology at the University of Washington and Fred Hutchinson Cancer Center, and Colin Pritchard, molecular pathologist and professor of laboratory science and director of the Genetics and Solid Tumors Laboratory at the University of Washington Medical Center.

Our panelists discuss the current treatment landscape for prostate cancer and how HRR testing can improve patient outcomes in this context.

Topics Covered  

• An introduction to metastatic prostate cancer testing, and what types of tests are standard of care, and the rationale for targeting prostate cancer using PARP
• Key findings from recent phase III randomized clinical trials
• Standards for optimal testing in prostate cancer, particularly concerning sample sources and the choice between next-generation sequencing (NGS) and polymerase chain reaction (PCR) methods
• common pitfalls or challenges in the arena of accurately reporting and interpreting findings from HRR tests
• Practical tips for optimal coordination among a multidisciplinary, cross-departmental team of healthcare providers and laboratory professionals when utilizing HRR testing in prostate cancer management.

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ASCP
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Connect with Dr. Cheng
Dr. Cheng on LinkedIn 

Connect with Dr. Pritchard
Dr. Pritchard 

Connect with Ms. Swails & Dr. Brown
Ms. Swails on Twitter
Dr. Brown on Twitter 

Resources
ASCP Membership 2024
Proposed FDA Regulation of Laboratory Developed Tests
Public Comment on the FDA’s Proposed Rule
Inside the Lab in the ASCP Store 

As CRC affects younger and more diverse populations, emerging tests for CRC biomarkers provide enormous utility for diagnosis. However, misdiagnosis of CRC, shifting demographics of those afflicted with CRC, and patient unfamiliarity with symptoms create challenges in identifying CRC. In this episode of Inside the Lab, hosts Dr. Ali Brown and Lotte Mulder are joined by Dr. Melissa Taggart, a board-certified pathologist at MD Cancer Center and Karla Valencia, a laboratory manager at MD Anderson Cancer Center to discuss the utility of biomarker testing for CRC.  

The hosts are also joined by Sarah Claeys, who was diagnosed with Stage I CRC in 2020 and is now actively fighting Stage IV recurrence with metastatic disease primarily in the liver, and ASCP Patient Champion Heather Tucker, who suffered from misdiagnosis for years before being diagnosed for CRC. She completed treatment 5 years ago. Sarah and Heather share their experiences with seeking both diagnosis and treatment, and provide insights on what information related to biomarkers were most valuable to them. 

Topics Covered in this podcast include:  

• How have tests for CRC evolved recently, and which biomarkers they test for; 
• How laboratory quality control is used to ensure the accuracy and reliability of colorectal cancer biomarker test results; 
• Factors involved with validating and implementing new biomarker assays for CRC in the laboratory; 
• Handling pre-analytical variables and potential interferences that may affect the interpretation of biomarker test results for colorectal cancer; 
• How pathologists integrate molecular and biomarker findings into pathology reports; 
• What information related biomarkers was most valuable from a patients’ perspective was most valuable when seeking treatment for CRC, as well as patient advice for healthcare professionals, including pathologists and laboratory professionals, regarding laboratory testing, including biomarker testing. 

Connect with ASCP 

ASCP 

ASCP on Facebook 

ASCP on Instagram 

ASCP on Twitter 

Connect with Ms. Bartosh, Ms. Courtright & Mr. Bowman 

University Health Laboratory Services 

Ms. Bartosh on LinkedIn  

Connect with Ms. Swails & Dr. Brown 

Ms. Swails on Twitter 

Dr. Mulder on Twitter 

Resources 

CAP Inspection Checklists 

ASCP Patient Champions Program 

Inside the Lab in the ASCP Store 

Recent developments in disease modifying therapies have been proven to slow the progression of cognitive decline associated with Alzheimer’s disease. 

And yet, we can only confirm a diagnosis of AD after a patient’s death. 

But what if we could use biomarkers to identify preclinical stage Alzheimer’s and step in long before a patient exhibits dementia? 

On this episode of Inside the Lab, your host, Ms. Kelly Swails, MT(ASCP) introduces us to Dr. Shih-Hsiu Jerry Wang, MD, PhD, Assistant Professor of Pathology and Assistant Professor of Neurology at the Duke University School of Medicine, and shares his talk on emerging biomarkers for the assessment of Alzheimer’s disease from the ASCP 2023 Annual Meeting. 

Dr. Wang explains how we measure AD right now and why there’s discordance between the clinical presentation and pathology of Alzheimer’s. 

Dr. Wang walks us through the core biomarkers for identifying AD per the AT(N) framework, describing the pros and cons of current detection methodologies and offering recommendations around when to use blood biomarkers versus PET imaging or CSF. 

Listen in for insight into the ongoing search for better AD biomarkers and learn what we are doing to diagnose Alzheimer’s in its early stages and intervene accordingly. 

Topics Covered  

· The clinical definition of Alzheimer’s disease and how it impacts cognitive function
· How we measure Alzheimer’s in pathology by amyloid plaques and neurofibrillary tangles
· Why there’s discordance between the clinical presentation and pathology of AD
· The core biomarkers for identifying Alzheimer’s disease per the AT(N) framework
· Identifying the stages of AD based on amyloid plaque, pathologic tau and neurodegeneration
· Examples of PET imaging for the different stages of AD and how imaging biomarkers predict cognitive decline
· The limitations of fluid biomarkers vs. imaging biomarkers to detect Alzheimer's disease
· Some of the emerging ultrasensitive biomarker detection methods in development for AD
· Using cerebral spinal fluids (CSF) vs. plasma biomarkers to identify Alzheimer's disease
· A comparison of the mass spectrometry vs. SIMOA methods of analyzing p-tau biomarkers
· Why Dr. Wang suggests blood biomarkers for AD screening (with confirmation by PET or CSF)
· Why SNAP-25, NfL and GFAP are not considered core biomarkers for Alzheimer’s disease
· The ongoing search for better biomarkers and ultrasensitive detection methods for AD 

Connect with ASCP
ASCP
ASCP on Facebook
ASCP on Instagram
ASCP on Twitter 

Connect with Dr. Wang
Dr. Wang at Duke University 

Connect with Ms. Swails
Ms. Swails on Twitter

Resources
Dr. Wang’s Slides from the ASCP Annual Meeting 2023
‘NIA-AA Research Framework: Toward a Biological Definition of Alzheimer’s Disease’ in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association
Inside the Lab in the ASCP Store 

The availability of targeted therapies has changed the landscape of cancer treatment in the last few years.  And two types of cancer particularly affected by these advances are melanoma and non-small cell lung carcinoma or NSCLC. What role does the laboratory play in the diagnosis and treatment of these cancers? How can pathologists and lab professionals work with oncologists to optimize biomarker testing and improve patient outcomes?  

On this episode of Inside the Lab, your hosts, Ms. Kelly Swails, MT(ASCP), and Dr. Ali Brown, MD, FASCP, are joined by Dr. Sanjay Mukhopadhyay, MD, Director of the Lung Pathology Service at the Cleveland Clinic, Ms. Lynnette Pineault, MBA, SCT(ASCP), Operations Manager for Laboratory and Genetic Services for Health Partners, and Mr. Jim Ondick, ASCP Patient Champion and IT Associate at The University of Kansas Health System, to discuss advancements in biomarker testing to improve NSCLC and melanoma cancer care.  

Listen in for insight on ensuring equitable patient access to biomarker testing and learn how to register for ASCP’s Immuno-Oncology Microlearning Courses for pathologists and laboratory professionals.  

Topics Covered   

• How targeted therapies and immunotherapies have improved treatment for melanoma and lung cancer in the past few years 
• Mr. Ondick’s success story of being treated with immunotherapy for metastatic melanoma and why he had little interaction with laboratory professionals during his diagnosis and treatment
• How pathologists can work with oncologists and surgeons to improve care for patients with cancer 
• The obstacles to providing laboratory services or support for biomarker testing 
• Dr. Mukhopadhyay and Ms. Pineault’s advice on designing workflows to optimize biomarker testing and ensuring equitable access for patients 
• Mr. Ondick’s take on what cancer patients should know about the laboratory team  

Connect with ASCP
ASCP
ASCP on Facebook 
ASCP on Instagram
ASCP on Twitter   

Connect with Dr. Mukhopadhyay 
Dr. Mukhopadhyay at Cleveland Clinic
Dr. Mukhopadhyay on LinkedIn  

Connect with Ms. Pineault
Ms. Pineault on ResearchGate
Ms. Pineault on LinkedIn  

Connect with Mr. Ondick
Mr. Ondick on LinkedIn
Mr. Ondick’s Story on ASCP Patient Champions  

Connect with Ms. Swails & Dr. Brown
Ms. Swails on Twitter
Dr. Brown on Twitter  

Resources
ASCP Patient Champions
ASCP Immuno-Oncology Microlearning Courses
Inside the Lab in the ASCP Store   

Sponsor
Bristol Myers Squibb 

Tests that are designed in-house to fulfill a clinical need (but aren’t FDA approved) qualify as laboratory developed tests. And these LDTs are currently regulated by CLIA. But the FDA is proposing a new rule that would give them oversight of the design and development of laboratory developed tests. So, what does that mean for us? How would this new legislation impact everyday practice inside the lab? 

On this episode of the podcast, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP, are joined by Dr. Gregory Sossaman, MD, Clinical Pathologist and Service Line Lead for Pathology and Lab Medicine at Ochsner Health, Dr. Jonathan Genzen, MD, Clinical Pathology Professor at the University of Utah and Chief Medical Officer and Senior Director of Government Affairs at ARUP Laboratories, and Mr. Matthew Schulze, Senior Director for the Center for Public Policy at ASCP, to discuss the implications of the proposed FDA regulations for LDTs. 

Our panelists share their anxiety around the labor and costs involved in complying with the new rule and describe how lab professionals might be forced into situations where we deny care due to regulations. Listen in to understand why public opinion favors the proposed rule and learn how to share your concerns with the FDA during the public comment period from October 3rd to December 4th, 2023. 

Topics Covered  

· How tests that are not FDA approved but designed in-house to fulfill a clinical need fall into the category of laboratory developed tests
· Examples of common LDTs used in academic medical centers + large community health systems
· The current regulations re: performance standards for LDTs under CLIA
· Dr. Sossaman, Dr. Genzen & Mr. Schulze’s concerns around the labor and costs involved in complying with the proposed FDA rule
· The lack of clarity re: what modifications to FDA approved tests would be allowed under the proposed regulations
· How direct-to-consumer testing, the pandemic and technological advances influenced the proposed FDA rule and why the general public is in favor of it
· How the proposed FDA regulations would affect our ability to respond in future pandemics

Connect with ASCP
ASCP
ASCP on Facebook
ASCP on Instagram
ASCP on Twitter 

Connect with Dr. Sossaman
Dr. Sossaman on LinkedIn 

Connect with Dr. Genzen
Dr. Genzen on LinkedIn 

Connect with Mr. Schulze
Mr. Schulze on LinkedIn 

Connect with Ms. Swails & Dr. Brown
Ms. Swails on Twitter
Dr. Brown on Twitter 

Resources
ASCP Membership 2024
Proposed FDA Regulation of Laboratory Developed Tests
Public Comment on the FDA’s Proposed Rule
Inside the Lab in the ASCP Store 

Working on the bench can feel like being in a black box. And as important as it is to advocate for patients, pathologists and laboratory professionals rarely have direct access to them. 

So, what can we do to encourage patient-centered care in the medical laboratory? 

On this episode of Inside the Lab, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Lotte Mulder, PhD, are joined by three members of the laboratory staff at University Hospital in San Antonio, Ms. Carrie Bartosh, MLS(ASCP), SV, Laboratory Supervisor in the Microbiology Department, Ms. Claudia Courtright, MLS(ASCP), Technical Supervisor in Microbiology Services, and Mr. Scott Bowman, MLS(ASCP), Bench Technologist, to discuss patient advocacy in the laboratory. 

Our panelists describe what laboratories can do to promote a culture of patient-centered care, sharing examples of situations when they advocated for patients from the bench and what they wish people knew about the value of the work done in the medical laboratory.  

Listen in for Ms. Bartosh, Ms. Courtright, and Mr. Bowman’s advice for laboratory professionals on avoiding burnout and learn how your laboratory can establish processes that support patient-centered care.  

Topics Covered 
· How frontline laboratory professionals can advocate for patients from the bench
· Instances of advocating for patients and how working in a culture of safety empowered those situations
· What the University Health laboratory does to continuously evaluate and improve its patient-centered care practices
· What laboratories can do to promote a culture of patient-centered care
· Why a punitive culture in the laboratory is not conducive to patient-centered care
· Examples of processes that support patient-centered care
· Advice to laboratory professionals on how to avoid burnout
· How Ms. Bartosh, Ms. Courtright, and Mr. Bowmanstay motivated to focus on advocacy
· Why laboratory professionals rarely have an opportunity to involve patients in the decision-making process around laboratory testing and results interpretation (and how impactful it is when they do)
· What our panelists wish patients knew about the value of the work we do in the medical laboratory 

Connect with ASCP
ASCP
ASCP on Facebook
ASCP on Instagram
ASCP on Twitter

Connect with Ms. Bartosh, Ms. Courtright & Mr. Bowman
University Health Laboratory Services
Ms. Bartosh on LinkedIn 

Connect with Ms. Swails & Dr. Brown
Ms. Swails on Twitter
Dr. Mulder on Twitter

Resources
CAP Inspection Checklists
ASCP Patient Champions Program
Inside the Lab in the ASCP Store