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 treatmentHow 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 ChampionsASCP Immuno-Oncology Microlearning Courses Inside the Lab in the ASCP Store   Sponsor Bristol Myers Squibb 

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 ASCPASCPASCP on FacebookASCP on InstagramASCP on Twitter Connect with Dr. WangDr. Wang at Duke University Connect with Ms. SwailsMs. Swails on TwitterResourcesDr. 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 AssociationInside the Lab in the ASCP Store 

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 pandemicsConnect with ASCPASCPASCP on FacebookASCP on InstagramASCP on Twitter Connect with Dr. SossamanDr. Sossaman on LinkedIn Connect with Dr. GenzenDr. Genzen on LinkedIn Connect with Mr. SchulzeMr. Schulze on LinkedIn Connect with Ms. Swails & Dr. BrownMs. Swails on TwitterDr. Brown on Twitter ResourcesASCP Membership 2024Proposed FDA Regulation of Laboratory Developed TestsPublic Comment on the FDA’s Proposed RuleInside the Lab in the ASCP Store 

What inspires a doctor to pursue pathology?  Dr. Elvio Silva, MD, was drawn to pathology because it’s the only specialty in medicine where you can SEE the disease. And his patient-centered approach to studying tumors has led to breakthrough research.  On this episode of Inside the Lab, Dr. Silva, Professor in the Department of Pathology at MD Anderson Cancer Center, joins our hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP, to discuss his storied career as a gynecologic pathologist. Dr. Silva explains the two kinds of pathology research, describing what inspired his revolutionary work in grading endocervical adenocarcinomas and why it’s crucial for medical journals to make room for new ideas. Listen in for insight on deciding between a career in academics versus private practice and find out what Dr. Silva learned from his most challenging cases in the diverse field of gynecologic pathology. Topics Covered · Dr. Silva’s accidental journey to becoming a gynecologic pathologist· How pathology is the only specialty where you can SEE the disease and why Dr. Silva views that as the best part of pathology· Dr. Silva’s response to people who say pathologists aren’t real doctors· How Dr. Silva thinks about deciding between academics vs. private practice· The two kinds of pathology research and what draws people  to research that involves understanding a disease· What Dr. Silva says to people who are intimidated by the diversity in gynecologic pathology· Why it’s challenging for pathologists to recognize when we’re wrong· The publications Dr. Silva is most proud of (and why those papers were initially rejected)· Examples of challenging cases and how they illustrate pitfalls pathologists should avoid· Why it’s crucial for societies and journals to make room for people with new and unusual ideas· Concerns around the training of pathology residentsConnect with ASCPASCPASCP on FacebookASCP on InstagramASCP on Twitter Connect with Dr. SilvaDr. Silva on TwitterDr. Silva on LinkedIn Connect with Ms. Swails & Dr. BrownMs. Swails on TwitterDr. Brown on TwitterResourcesDr. Silva on ResearchGateInside the Lab in the ASCP Store 

During this recorded 2022 ASCP Annual Meeting session, multidisciplinary faculty will discuss the science and latest evidence on emerging biomarkers, resistance mutations, immuno-oncology (I-O) resistance mechanisms, and I-O treatment options (e.g., combination therapy involving CTLA-4 inhibitors) in metastatic NSCLC.  In addition, they will address how to integrate next generation sequencing (NGS) into your biomarker testing workflows and optimize its use for patients.  Finally, they will share best practices in biomarker testing, reporting, and communication to help pathologists and laboratory professionals guide medical oncologists and other team members in the appropriate diagnosis, testing, and treatment for patients.  The activity offers 1.0 CME/CMLE credit.  The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians.   Learning ObjectivesUpon completion of this activity, you should be able to:·         Describe ongoing investigational efforts regarding emerging biomarkers in metastatic NSCLC ·         Utilize NGS to identify current and emerging biomarkers to predict response to personalized therapies for patients with metastatic NSCLC ·         Employ strategies for optimizing workflows and turnaround times for NGS ·         Discuss the science behind resistance mechanisms in patients with metastatic NSCLC ·         Recognize the use of emerging I-O combination therapies and potential biomarkers in patients with metastatic NSCLC ·         Develop ways to improve communication among pathologists, oncologists, and other members of the multidisciplinary lung cancer care team FacultyDiana N. Ionescu MD, FRCPC, FCAP Consultant Pathologist and Medical Lead Anatomical Pathology Medical Director BC Cervical Cancer Screening Laboratory Medical Director Clinical Trials, BC Cancer Laboratories Clinical Professor of Pathology, University of British Columbia Doru Paul, MD, PhDAttending Physician, Division of Hematology and Medical Oncology Weill Cornell and New York Presbyterian Hospital  Faculty DisclosuresThe following Panel/Faculty members have relevant financial relationships to disclose:  | Faculty Member | Ineligible Company | For what role? | Diana Ionescu, MD | AstraZeneca, Bayer, BMS, Merck, Pfizer, Roche | Consultant, Consultant, Consultant, Consultant, Consultant, Consultant Dr. Paul has no relevant financial relationships to disclose All of the relevant financial relationships listed for these individuals have been mitigated  Commercial SupportFunded by an independent educational grant from AstraZeneca Pharmaceuticals

The emergence of HER2-low therapies for metastatic breast cancer is a paradigm shift in the traditional binary classification of a patient’s HER2 status, creating a need for practice changes in pathology necessitated by the expansion in how HER2-low breast cancer needs to be classified and treated. During this recorded 2022 ASCP Annual Meeting session, a moderated expert faculty panel will discuss evolving and emerging trends in breast cancer classification and reporting across the HER2+ spectrum. They will also discuss how pathologists and laboratory professionals can prepare for HER2-low classification, tracking, and reporting. In addition, they will review some of the current challenges in HER2 testing and explore opportunities to prepare for the future landscape of HER classification in breast cancer.  The activity offers 1.0 CME/CMLE credit.  The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians.  FacultySwikrity U. Baskota, MDAssistant Professor, Department of Pathology, and Cell BiologyColumbia University Irving Medical Center Marilyn Bui, MD, PhDSenior Member and Professor of PathologyScientific Director of Analytic Microscopy CoreProgram Director of Cytopathology FellowshipMoffitt Cancer Center & Research Institute Mamatha Chivukula, MD, FASCPDirector of Breast Pathology Services and IHC LabMills Peninsula Medical Center, Sutter Health Affiliate Joseph Kim, MD, MBA, MPHPresidentQ Synthesis Credit Designation Statement  The ASCP designates this enduring podcast activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only credit commensurate with the extent of their participation in the activity.  ASCP designates this enduring podcast activity for a maximum of 1.0 CMLE credit.  This activity meets CMP and state re-licensure requirements for laboratory personnel.  For questions regarding CME credit, please contact ASCP Customer Service at 1-800-267-2727, during normal business hours: Monday through Friday, 8 a.m. to 6 p.m. Eastern Time  Method of Participation  To complete the activity and receive credit, the participant must complete the podcast activity. CME certificates will be provided on-line.  Commercial Support Funded by independent educational grants from AstraZeneca and Daiichi Sankyo, Inc.Provided by the American Society for Clinical Pathology in partnership with Q Synthesis.

In the 100 years since its founding in 1922, the American Society for Clinical Pathology has guided the application and evolution of pathology and laboratory medicine. But how much do you know about the history of ASCP? On this episode of Inside the Lab recorded live at the ASCP Annual Meeting in Chicago, our hosts, Ms. Kelly Swails and Dr. Lotte Mulder, are joined by Team Total Kuality, Dr. Kamran Mirza, MD, PhD, Associate Professor of Pathology at Loyola Medicine, and Dr. Theresa Tellier-Castellone, EdD, MPH, MLS(ASCP)CM, Program Director for the School of Medical Technology at Our Lady of Fatima and Rhode Island Hospital; Team Buffy Coat, Dr. Kim Sanford, MD, MASCP, MT(ASCP), Past President of ASCP, and Dr. Will Finn, MD, MASCP, Medical Director at Warde Medical Lab and Past President of ASCP; and Team Diplococcus, Ms. Christy Nickel, MHA, MLS(ASCP)CM, CPHQ, ASCP CMLA Chair and Director of the Clinical Laboratory at Bryan Health, and Ms. Jeannie Guglielmo, MS, MAT, MLS(ASCP)CM, Chair of the Clinical Laboratory Science Program at Stony Brook University, for an enthusiastic game of ASCP Trivia. Our teams answer questions about the ethical issues that concerned ASCP in its early years and the goals of the organization that have remained consistent since its founding in 1922. They buzz in to share their knowledge of how we made history by electing Dr. Emma Sadler Moss as President in 1955. Listen in as the teams compete for bragging rights (and a glow-in-the-dark Erlenmeyer flask). Topics Covered · Dr. Emma Sadler Moss’ roles at Charity Hospital in New Orleans and with ASCP in the 1950s· The ethical issues around the practice of pathology that concerned ASCP in its early years· Other professional organizations founded at ASCP meetings· Why ASCP changed its name to the American Society for Clinical Pathology in 2002· How ASCP’s Center for Global Health is responding to disasters and expanding laboratory services all over the world· What goals ASCP established when the organization was founded in 1922 (and how those goals have remained consistent in the years since)· How ASCP made history by electing the first female president of a medical organization in 1955 Connect with ASCPASCPASCP on FacebookASCP on InstagramASCP on Twitter Connect with Team Total KualityDr. Mirza on TwitterDr. Tellier-Castellone on TwitterConnect with Team Buffy CoatDr. Sanford on TwitterDr. Finn on Twitter Connect with Team DiplococcusMs. Nickel on LinkedInMs. Guglielmo on LinkedInConnect with Ms. Swails & Dr. MulderMs. Swails on TwitterDr. Mulder on Twitter Resources ASCP Annual MeetingInside the Lab in the ASCP Store 

This podcast will help pathologists gain deeper skills in improving HER2 IHC testing in patients with breast cancer. and includes the following topics:Optimizing IHC scoring across the HER2 spectrum in patients with breast cancerGuidelines for conducting IHC and ISH testing of HER2 in patients with breast cancerApplication through cases of patients with breast cancer along the lower spectrum of HER2 expressionSuggestions for effective coordination and collaboration among pathologists, oncologists, and other key members of the cancer care teamThe activity offers 0.75 CME/CMLE credit.Learning Objectives:Upon completion of this activity, you should be able to:Appropriately score HER2 levels via immunohistochemistry (IHC) in routine and complex breast cancer cases in accordance with guidelinesDescribe the factors that may affect IHC performance across the HER2 spectrumUtilize in situ hybridization (ISH) testing in breast cancer cases when appropriate in accordance with guidelinesDiscuss ways to prepare laboratories and cancer centers for HER2-low breast cancer identification, tracking, and reportingFaculty:Aysegul A Sahin, MDDirector of Educational OperationsDepartment of Pathology, Division of Pathology/Lab MedicineThe University of Texas MD Anderson Cancer CenterHouston, TXAli Brown, MD, FASCPChief Officer, Medical QualityAmerican Society for Clinical PathologyWashington, DCErin Downs-Kelly, DODirector, Breast PathologyCleveland ClinicCleveland, OHThe American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians.Credit Designation StatementThe ASCP designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only credit commensurate with the extent of their participation in the activity.ASCP designates this enduring material for a maximum of 0.75 CMLE credit. This activity meets CMP and state re-licensure requirements for laboratory personnel.For questions regarding CME credit, please contact ASCP Customer Service at 1-800-267-2727, during normal business hours: Monday through Friday, 8 a.m. to 6 p.m. Eastern TimeMethod of ParticipationTo complete the activity and receive credit, the participant must complete the online course. CME certificates will be provided on-line.Provided by the American Society for Clinical Pathology in partnership with Q-Synthesis, LLC and Clinical Care Options, LLC.Funded by independent educational grants from AstraZeneca Pharmaceuticals and Daiichi Sankyo, Inc.

This 45-minute podcast is the first of two designed to help pathologists understand the latest evidence regarding HER2-low breast cancer, HER2 testing guidelines, the implications for the pathology team as HER2-low therapies emerge, and ways to streamline communications with oncologists and other members of the cancer care team. The podcast features authentic patient cases, scenarios, and discussion of digital slide images to engage learners.This first podcast will help pathologists understand the science and emerging evidence around HER2-low breast cancer, as well as changes to practice that will be necessary in preparation for anticipated approvals of HER2-low breast cancer therapies and includes the following topics:Science and emerging evidence around HER2-low breast cancerConsiderations for laboratories and cancer centers related to the potential approval of HER2-low therapies (eg, the need to document HER2 IHC and ISH status, enhanced communication with oncologists and other members of the cancer care team)Application through cases of patients with breast cancer along the lower spectrum of HER2 expressionSuggestions for effective coordination and collaboration among pathologists, oncologists, and other key members of the cancer care teamThe activity offers 0.75 CME/CMLE credit.Learning Objectives:Upon completion of this activity, you should be able to:Describe the science and emerging evidence around the diagnosis and treatment of HER2-low breast cancerDiscuss potential updates to laboratory processes and procedures to prepare for the anticipated emergence of HER2-low as a diagnostic category of breast cancerApply principles of leadership to engage and inform members of the cancer care team about ongoing research around HER2-low breast cancerOutline ways to improve communication and coordination among pathologists, oncologists, and other members of the cancer care team when discussing HER2 test results in patients with breast cancerFaculty:Aysegul A Sahin, MDDirector of Educational OperationsDepartment of Pathology, Division of Pathology/Lab MedicineThe University of Texas MD Anderson Cancer CenterHouston, TXAli Brown, MD, FASCPChief Officer, Medical QualityAmerican Society for Clinical PathologyWashington, DCErin Downs-Kelly, DODirector, Breast PathologyCleveland ClinicCleveland, OHThe American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians.Credit Designation StatementThe ASCP designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only credit commensurate with the extent of their participation in the activity.ASCP designates this enduring material for a maximum of 0.75 CMLE credit. This activity meet CMP and state re-licensure requirements for laboratory personnel.For questions regarding CME credit, please contact ASCP Customer Service at 1-800-267-2727, during normal business hours: Monday through Friday, 8 a.m. to 6 p.m. Eastern TimeMethod of ParticipationTo complete the activity and receive credit, the participant must complete the online course. CME certificates will be provided on-line.Provided by the American Society for Clinical Pathology in partnership with Q-Synthesis, LLC and Clinical Care Options, LLC.Funded by independent educational grants from AstraZeneca Pharmaceuticals and Daiichi Sankyo, Inc.

This 45-minute podcast features the expertise of a pathologist and an oncologist highlighting important and practice-changing developments related to the use of Ki67 biomarker testing in patients with HR-positive/HER2-negative early breast cancer, such as new clinical data with immediate implications for patient care. Case-based, and with expert perspectives and recommendations, this podcast addresses key educational gaps and controversies related to optimal Ki67 biomarker testing methods, including challenges with standardization, interpreting findings, and potential therapeutic implications for patients with HR-positive/HER2-negative early breast cancer to optimize clinical outcomes.Topics covered include:Analytical validity of Ki67 as a diagnostic assay, application of results in clinical practice, and relevance to therapyCurrent and emerging therapies for HR-positive/HER2-negative early-stage breast cancercurrent standardized methodologies for Ki67 quantificationOptimizing workflows and communications with the multidisciplinary teamThe activity offers 0.75 CME/CMLE credit.The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians.Learning Objectives:Upon completion of this activity, you should be able to:Incorporate the evidence on the current use of Ki67 as a predictive and prognostic biomarker into clinical practiceEvaluate the clinical validity, utility, and differences among Ki67 assessment techniquesIntegrate best practices for Ki67 testing methodology, standardization, and reportingIdentify patients with high-risk features who may benefit from the addition of CDK4/6 inhibitor therapy to endocrine therapy in the adjuvant settingFoster collaborative discussions and workflows between oncologists, pathologists and the multidisciplinary team on recent clinical evidence to guide personalized treatment planning for HR-positive/HER2-negative early breast cancerIdentify patients with HR-positive/HER2-negative early breast cancer that expresses Ki67 who may be eligible for ongoing clinical trialsFaculty: Sunil S. Badve, MD, FRCPathVice Chair, Pathology Cancer Programs, Department of Pathology and Laboratory MedicineEmory University School of MedicineAtlanta, GA Manali Bhave, MDAssistant Professor, Department of Hematology and Medical OncologyEmory University School of MedicineAtlanta, GAThe American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians.Credit Designation StatementThe ASCP designates this internet activity for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only credit commensurate with the extent of their participation in the activity.ASCP designates this internet activity for a maximum of 0.75 CMLE credit. This activity meets CMP and state re-licensure requirements for laboratory personnel.For questions regarding CME credit, please contact ASCP Customer Service at 1-800-267-2727, during normal business hours: Monday through Friday, 8 a.m. to 6 p.m. Eastern TimeMethod of ParticipationTo complete the activity and receive credit, the participant must complete the online course. CME certificates will be provided online.Provided by the American Society for Clinical Pathology in partnership with Clinical Care Options, LLCThis activity is supported by an educational grant from Lilly.