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
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‘10 Disruptive Forces in Healthcare’ Provide Challenges for Clinical Laboratories and Pathology Groups Forced to Respond to a Changing Marketplace

Transition to value-based reimbursement tops Insigniam’s list of factors altering healthcare landscape

Management consulting firm Insigniam recently identified “10 Disruptive Forces in Healthcare”. Several of these development create significant implications for clinical laboratories and anatomic pathology groups that are navigating today’s rapidly-changing healthcare landscape.

ACA and Aging Population Reshaping Healthcare

“I have been doing healthcare for 33 years at this point. And there has been more change in the last three [years] than at any time, and it’s by a long shot,” declared Donald Casey, Jr., Chief Executive Officer of the Medical Segment of Cardinal Health in Ohio. He was quoted by Insigniam Quarterly.

donald casey

Donald Casey, Jr., Chief Executive Officer of the Medical Segment of Ohio-based Cardinal Health, has firsthand experience responding to the fundamental changes taking place in healthcare today. Casey points to the Affordable Care Act (ACA) and an aging population as the two drivers behind what is a fundamental reshaping of American healthcare. (Photo copyright: Cardinal Health.)

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New Tool to Identify Tumor Heterogeneity Could Help Pave Way for Personalized Cancer Therapies and Help Pathologists Add Value for Oncologists

Ohio State University study shows correlation between genetic variability among cancer cells within tumors and the survival of patients with head-and-neck cancers

Anatomic pathologists and clinical laboratories  may gain a tool to identify tumor heterogeneity. This would enable them to ultimately guide personalized cancer therapies if a new method for measuring genetic variability within a tumor and predicting outcomes is confirmed in future studies.

Scientists Seek Cause of Resistance to Cancer Treatment

The new tool was dubbed “MATH” by researchers at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute  (OSUCCC–James). MATH is the scoring method they developed and stands for  mutant-allele tumor heterogeneity. MATH was used to measure the genetic variability among cancer cells within tumors from 305 patients with head and neck squamous cell carcinoma  (HNSCC), treated at multiple institutions, from The Cancer Genome Atlas.

In announcing the study results, OSUCCC-James stated  that cancers that showed high genetic variability— called “intra-tumor heterogeneity”—correlated with lower patient survival.

James Rocco, MD, PhD, Professor in the Department of Otolaryngology-Head and Neck Surgery at The Ohio State University Wexner Medical Center, and his colleagues, used MATH values “to document a relation between intra-tumor heterogeneity and overall survival in any type of cancer.” (more…)

UCLA Health Pilot Program Looks to Integrate Genomic Patient Data into Epic EHRs: Currently Clinical Pathology Laboratories Store This Data

Use of genomic data collector could mean competition for medical laboratories that now store, analyze, and interpret genetic data

UCLA Health is working to integrate genomic patient data into its Epic electronic health record (EHR) system. This pilot project could signal potential competition for pathology groups and clinical laboratories that currently are the main repositories for the storage, analysis, and interpretation of genetic data.

Pilot Program Designed to Support Precision Medicine Research

As it becomes faster, cheaper, and easier to sequence human exomes and genomes, the challenge is how to store a patient’s gene data and make it available at the time care is provided.

UCLA Health is teaming with Seattle-based startup ActX in an effort to solve this problem. ActX represents a relatively new type of company—a genomic data collector (GDC)—and it is developing a critical solution—EHR Integration. The emergence of GDCs could affect clinical laboratories that currently provide most of the storage, analysis, and interpretation of genetic data.

ActX Founder and CEO Andrew Ury, MD, told MedCity News that, “While genetics can’t predict everything, genetics can predict more and more and whether a patient has a side effect. We think this is the future.”

ActX currently provides genomic decision support to physicians using Allscripts and Greenway Health ambulatory EHRs. A patient’s genetic information is collected through a saliva sample and then analyzed in real-time. Using a patient’s genetic code, the ActX application alerts physicians to possible medication adverse reactions and efficacy as well as actionable medical risks and patients’ carrier status. (more…)

California’s Massive Microarray SNP Genotyping Project Processed Genetic Data from More Than 100,000 Volunteers and Characterized 70 Billion Genetic Variants in 14 months

Faster sequencing speed and accuracy could fuel growth of biomarkers and lead to development of new medical laboratory tests and therapeutic drugs

Trailblazing methods used to create a treasure trove of genetic data from 100,000 Californians could pay dividends for clinical laboratories and pathology groups if similar projects identify novel biomarkers and fuel the development of new clinical laboratory tests and therapeutic drugs.

In fact, California is once again in the forefront, this time with a major program to create a big database of genetic data. The program is called the Genetic Epidemiology Research on Adult Health and Aging (GERA). It is a collaboration between the Kaiser Permanente Northern California Research Program on Genes, Environment, and Health (RPGEH) and the Institute for Human Genetics at the University of California, San Francisco (UCSF) that began in 2009. (more…)

New England Journal of Medicine Publishes Study Where Researchers Call Attention to Lack of Knowledge about Some Genes Included in Gene Panel Tests for Inherited Cancers

Researchers are concerned about the lesser-known genes included in the test and also point out that little published research exists to support use of these genes for clinical laboratory testing

Gene-panel tests for inherited cancers were scrutinized by a group of 17 prominent international genetic researchers in a study published by the New England Journal of Medicine (NEJM) this summer titled “Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk.” These experts pointed out that, for many of the genes included in these test panels, there remains much uncertainty about their role in various cancers and other diseases.

What will be of greatest interest to pathologist, Ph.D.s, and medical laboratory professionals currently performing molecular diagnostics assays and genetics is that these experts proposed greater regulation of unvalidated gene-panel tests for inherited cancers. In the NEJM, the authors provided some examples of genetic tests, such as those offered by Myriad Genetics, Inc. (NASDAQ:MYGN), Ambry Genetics, Invitae (NYSE:NVTA), and Illumina, Inc. (NASDAQ:ILMN) and noted that risks posed by many mutations occurring on these panels are unknown.

These panel tests can include more than 100 genes, 21 of which are an indication of breast cancer, including BRCA1 and BRCA2, stated the paper. (more…)

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