News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

What Key Laboratory Leaders Will Learn at This Week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Executives and pathologists from many of the nation’s most prominent clinical laboratories are on their way to the Crescent City today to share best practices, hear case studies from innovative labs, and network

NEW ORLEANS—This afternoon, more than 900 lab CEOs, administrators, and pathologists will convene for the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management conference. Three topics of great interest will center around adequate lab staffing, effective cost management, and developing new sources of lab testing revenue.

Important sessions will also address the explosion in next-generation sequencing and genetic testing, proposed FDA regulation of laboratory-developed tests (LDTs), and innovative ways that clinical laboratories and pathology groups can add value and be paid for that additional value.

All this is happening amidst important changes to healthcare and medicine in the United States. “Today, the US healthcare system is transforming itself at a steady pace,” explained Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “Big multi-hospital health systems are merging with each other, and payers are slashing reimbursement for many medical lab tests, even as healthcare consumers want direct access to clinical laboratory tests and the full record of their lab test history.

“Each of these developments has major implications in how clinical laboratories serve their parent organizations, offer services directly to consumers, and negotiate with payers for fair reimbursement as in-network providers,” Michel added. “Attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management equips lab leaders with the tools they’ll need to make smart decisions during these challenging times.”

Executive War College

Now in its 28th year, the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management convenes April 25-26 in New Orleans. Executive War College extends to a third day with three full-day workshops: LEAN fundamentals for lab leaders, a genetic testing program track, and a digital pathology track. Learn more at www.ExecutiveWarCollege.com. (Photo copyright: The Dark Intelligence Group.)

Challenges and Opportunities for Clinical Laboratories

With major changes unfolding in the delivery and reimbursement of clinical services, clinical laboratory and pathology practice leaders need effective ways to respond to the evolving needs of physicians, patients, and payers. As The Dark Report has often covered, three overlapping areas are a source of tension and financial pressure for labs:

  • Day-to-day pressures to manage costs in the clinical laboratory or pathology practice.
  • The growing demand for genetic testing, accompanied by reimbursement challenges.
  • Evolving consumer expectations in how they receive medical care and interact with providers.

Addressing all three issues and much more, the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management features more than 80 sessions with up to 125 lab managers, consultants, vendors, and in vitro diagnostic (IVD) experts as speakers and panelists.

Old-School Lab Rules Have Evolved into New-School Lab Rules

Tuesday’s keynote general sessions (to be reported exclusively in Wednesday’s Dark Daily ebriefing) will include four points of interest for clinical laboratory and pathology leaders who are managing change and pursuing new opportunities:

  • Positioning the lab to prosper by serving healthcare’s new consumers, new care models, new payment models, and more, with Michel at the podium.
  • How old-school lab rules have evolved into new-school lab rules and ways to transition the lab through today’s disrupters in healthcare and the clinical laboratory marketplace, with Stan Schofield, Managing Principal of the Compass Group.
  • The growing trend of clinical laboratory-pharmacy relationships with David Pope, PharmD, CDE, Chief Pharmacy Officer at OmniSYS, XIFIN Pharmacy Solutions.
  • Generating value by identifying risk signals in longitudinal lab data and opportunities in big data from payers, physicians, pharma, and bioresearch, with Brad Bostic, Chairman and CEO of hc1.

Wednesday’s keynote sessions (see exclusive insights in Friday’s Dark Daily ebriefing) explore:

Wednesday’s keynotes conclude with a panel discussion on delivering value to physicians, patients, and payers with lab testing services.

Clinical Labs, Payers, and Health Plans Swamped by Genetic Test Claims

Attendees of the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management may notice a greater emphasis on whole genome sequencing and genetic testing this year.

As regular coverage and analysis in The Dark Report has pointed out, clinical laboratories, payers, and health plans face challenges with the explosion of genetic testing. Several Executive War College Master Classes will explore critical management issues of genetic and genomic testing, including laboratory benefit management programs, coverage decisions, payer relations, and best coding practices, as well as genetic test stewardship.

This year’s Executive War College also devotes a one-day intensive session on how community hospitals and local labs can set up and offer genetic tests and next-generation sequencing services. This third-day track features more than a dozen experts including:

During these sessions, attendees will be introduced to “dry labs” and “virtual CLIA labs.” These new terms differentiate the two organizations that process genetic data generated by “wet labs,” annotate it, and provide analysis and interpretation for referring physicians.

State of the Industry: Clinical Lab, Private Practice Pathology, Genetic Testing, IVD, and More

For lab consultants, executives, and directors interested in state-of-the-industry Q/A and discussions concerning commercial laboratories, private-practice pathology, and in vitro diagnostics companies, a range of breakout sessions, panels, and roundtables will cover:

  • Action steps to protect pathologists’ income and boost practice revenue.
  • Important developments in laboratory legal, regulatory, and compliance requirements.
  • New developments in clinical laboratory certification and accreditation, including the most common deficiencies and how to reach “assessment ready” status.
  • An update on the IVD industry and what’s working in today’s post-pandemic market for lab vendors and their customers.
  • Federal government updates on issues of concern to clinical laboratories, including PAMA, the VALID Act, and more.

Long-time attendees will notice the inclusion of “Diagnostics” into the Executive War College moniker. It’s an important addition, Michel explained for Dark Daily.

“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he noted. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”

Key managers of medical laboratories, pathology groups, and in vitro diagnostics have much to gain from attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, now in its 28th year. Look for continued coverage through social media channels, at Dark Daily, and in The Dark Report.

Clinical laboratories are invited to continue the conversations by joining the Executive War College Discussion Group and The Dark Report Discussion Group on LinkedIn.

Liz Carey

Related Information:

Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management Agenda

Six Important Themes to Help Labs Succeed

Executive War College Press

The Dark Report

Dark Daily eBriefings

The Dark Report Discussion Group

Executive War College Discussion Group

Genomic Companies Collaborate to Develop Facial Analysis Technology Pathologists Might Eventually Use to Diagnose Rare Genetic Disorders

Phenotypic data combined with artificial intelligence provides a new biomarker for genetic laboratories to use when diagnosing disease

Researchers are demonstrating that facial analysis and facial recognition technology can play a useful role in helping pathology and medical laboratory scientists diagnose disease. This is just the latest example of how advances in different technologies can add new sources of biomarkers for clinical laboratories.

Biomarkers used by clinical laboratories and anatomic pathologists are usually biological substances or states that can be measured during testing either in vivo or in vitro. However, clinical laboratories may soon be working with biomarkers based on measurable aspects of external human anatomy. One such biomarker employs facial analysis and facial recognition technology to produced phenotypic data that could help pathologists diagnose rare genetic disorders. A human phenotype is data comprised of a person’s “observable characteristics or traits.”

Phenotypic Data from Photographs

Three genomics companies: FDNA, GeneDx, and Blueprint Genetics, are collaborating on a unique project, dubbed Face2Gene Labs. They are using a facial recognition application called Face2Gene developed by FDNA. The application uses artificial intelligence (AI) and phenotyping technology to extract data from facial photographs of patients. The data is then examined and compared to a database of hundreds of thousands of patterns that were generated from photos of patients with known rare genetic disorders. The algorithm then compiles a list of possible diagnoses. The goal is to produce phenotypic data that clinicians can transmit in real-time directly to medical laboratories for analysis.

“Trying to diagnose patients with genetic sequencing is like searching for a pin in a 22,000-needle haystack,” stated Dekel Gelbman, CEO, FDNA, in a news release. “By providing accurate phenotypic and clinical data to the lab directly at the point of genetic interpretation, we are truly realizing the promise of precision medicine. And, with the power of artificial intelligence behind it, clinicians will be pointed toward potential diagnoses that they may have never otherwise considered.”

The Face2Gene application developed by FDNA uses artificial intelligence to compare digital photographs of patients’ faces against hundreds of thousands of stored patterns to help clinicians identify genetic disorders in children. (Photo copyright: FDNA.)

Solomon goes on to praise GeneDx and Blueprint Genetics as examples of innovative and renowned labs adopting technology that will lead the way in pinpointing rare disease and promote further medical advancements.

“This is an important collaboration for several reasons,” states Ben Solomon, MD, a Clinical Geneticist and Managing Director of GeneDx, in the news release. “It’s a great way to leverage clinical and genetic information and machine learning approaches to find answers for the clinicians, patients, and families GeneDx serves. Aside from providing answers, this integration will make the diagnostic testing process easier, smoother, and more enjoyable for clinicians.”

85% Increase in Diagnostic Yield with Addition of Phenotypic Data

A recent multi-center study called PEDIA (short for Prioritization of Exome Data by Image Analysis) looked into the accuracy of genetic testing when using FDNA’s Face2Gene tool. The study, conducted by researchers at the Berlin Institute of Health and Charité University of Medicine in Berlin, showed promising results of the collaboration.

“We estimate that the addition of phenotypic features [encoded in HPO terms] increases the diagnostic yield to about 60% [from 25% without],” stated Peter Krawitz, MD, PhD, and Principal Investigator for PEDIA. “When adding facial analysis, FDNA’s technology, to that process, the diagnostic yield increases to more than 85%,” he explained in the FDNA news release.

The Rarity Paradox and Diagnosing Genetic Disorders in Children

According to Global Genes, a rare disease patient advocacy non-profit organization, one in 10 Americans (approximately 30 million people) suffer from a rare genetic disorder. These disorders also affect the same percentage of people worldwide, or about 350 million people. There are more than 7,000 distinct rare diseases known to exist and approximately 80% of those illnesses are caused by faulty genes. In addition, about half of the people affected by rare genetic illnesses are children.

“We call it the rarity paradox,” stated Gelbman in an article published in Wired. “Each rare disease in itself affects very few people, but on aggregate the effect is pretty staggering.”

The three companies hope their collaboration will help clinicians determine faster, more accurate diagnoses, while diminishing anxiety among patients and their families regarding the unknowns of rare genetic disorders.

“Since 2012, Blueprint Genetics has been developing technological innovations in sequencing and clinical interpretation to improve the quality and performance of rare disease diagnostics,” noted Tero-Pekka Alastalo, MD, PhD, President, Chief Medical Officer of Blueprint Genetics, in the FDNA news release. “It’s great to see how these innovations are now helping the genetics community and patients suffering from inherited disorders. Combining these technological innovations with our transparent approach to diagnostics and next generation phenotyping tools like Face2Gene represents the next steps forward in molecular genetic diagnostics.”

Pathology groups and clinical laboratories are advised to monitor this exciting development in genomic research. It illustrates how unrelated technologies, such as facial analysis software, could soon be used for diagnostic purposes to detect the presence of genetic disorders, and to determine the best therapies for patients. Labs will want to be prepared to engage with clinicians who adopt this technology and to answer patients’ questions about it.

—JP Schlingman

Related Information:

FDNA Announces Collaboration with GeneDx and Blueprint Genetics in the Launch of Face2Gene LABS

FDNA Expands Facial Analysis Reach to 2,000 Syndromes

Groups Explore Facial Analysis Software for Inherited Disease Diagnosis, Research

Your Face Could Reveal if You Have a Rare Disease

Face2Gene: Take a Headshot – Get a Diagnosis

Attention Pathologists! New Prostate Cancer Test Has CPT Code, NCCN Guideline Recommendation, and Potential Market of One Million Prostate Biopsies Annually

OPKO Health’s 4Kscore test predicts the rate of high-risk prostate cancer and may become a useful business case study for other labs developing proprietary diagnostic tests

Clinical laboratories and biotech companies with new medical laboratory tests are struggling to win coverage by Medicare and private payers. How big is this problem? There are currently tens of thousands of molecular diagnostic assays and genetic tests offered for clinical use.

Any lab company seeking to obtain an appropriate Current Procedural Terminology (CPT) code, favorable coverage guidelines, and adequate reimbursement from health insurers for its new lab test faces three big challenges, and they are related. First, payers are simply overwhelmed with requests to review new genetic tests. The flood of new test submissions exceeds the capability of payers to respond.

Most Payers May Not Have Right Scientific Expertise to Evaluate Genetic Tests

Second, most health insurance plans lack physicians and medical professionals who have the necessary experience in laboratory medicine, molecular diagnostics, and genetic medicine to evaluate these lab test submissions in a knowledgeable way. (more…)

;