Who would have guessed that Angelina Jolie would do a multi-million-dollar favor to Myriad Genetics, Inc.? Jolie caused quite a stir earlier this year when she went public with the news that she had done a prophylactic double mastectomy after she had learned the results of her BRCA test for breast cancer risk. That news
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A companion diagnostic device can be an in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
Because the companion diagnostic test is designed to be paired with a specific drug, the development of both products requires close collaboration between experts in both the Food and Drug Administration (FDA)’s device center, which evaluates the test to determine whether it may be cleared or approved, and FDA’s drug center, which evaluates the drug to determine whether it may be approved.
The process works best when development of the test begins before the drug enters clinical trials, increasing the likelihood that the participants in the trials are the patients most likely to benefit from the treatment.
Companion diagnostics can provide information such as the following:
- Test results that identify a population in which the therapeutic product will achieve greater (or little) effectiveness
- Test results that identify a patient population that should not receive a particular therapeutic product due to the possibility for therapy-related serious adverse events
- Test results that identify the characteristics of a disease, condition, or disorder to specifically determine what type of treatment is appropriate
- Test results that are the basis for selecting a safe and efficacious therapeutic dose.
Development of companion diagnostics has been supported by regulatory agencies, such as the FDA. The biopharmaceutical industry has also embraced the co-development of companion diagnostics, with companies either partnering on their development or pursuing in-house programs.
Genetic Engineering & Biotechnology News notes that a frequently cited example of a successful personalized therapeutic and companion diagnostic pair is Genentech’s antibody-based drug, Herceptin® (trastuzumab), which treats patients with cancers that overexpress the HER2 receptor (such as breast cancer), and the companion diagnostic test, HercepTest. The diagnostic test was developed to select patients that will benefit from treatment with Herceptin, a blockbuster drug.
“When it comes to hiring senior leaders, labs today are more diligent in recruiting and interviewing candidates for key executive and management positions. One reason for this change is the shrinking financial margins at most labs.”
—Adam Slone, Founder, Slone Partners
CEO SUMMARY: There is a clear shift in the hiring practices of clinical labs and pathology
CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding growth at this lab company. Here is an inside look at six factors which
CEO SUMMARY: There will be an expanding role for innovative clinical labs as healthcare moves forward on its path toward personalized medicine. However, to capitalize on this opportunity, pathology groups and clinical labs will need to beef up their information systems. They will also need to recruit lab staff who are skilled in interpreting molecular
CEO SUMMARY: Digital pathology holds the promise of interconnecting pathologists around the globe in ways that advance diagnostic accuracy and improve patient outcomes. One pioneering digital pathology collaboration involves the pathology departments at the medical schools of the University of California, Los Angeles (UCLA) and Zhejiang University in Hangzhou, China.
PART ONE OF A SERIES
CEO SUMMARY: Community hospitals are recognizing increased interest in personalized medicine among consumers. One expert predicts that this will create opportunities for hospital labs and pathology groups to add value by offering subspecialty expertise in molecular diagnostics, genetic testing, and “companion informatics.” At the University of Louisville School of Medicine, the Department of Pathology and
CEO SUMMARY: Taken collectively, the speakers at the opening session of the 17th Annual Executive War College on Lab and Pathology Management had a powerful message to the nearly 700 attendees. After years of slow movement, a rapid transformation of the American healthcare system is about to unfold. There will be opportunities for clinical labs
CEO SUMMARY: Once again, Roche is hunting for gene sequencing and gene analysis technology that can support its goal of being a world leader in gene-based therapeutics and clinical lab testing that utilizes gene tests and molecular diagnostics. Last week, Roche launched a hostile stock tender offer for shares of Illumina, Inc., of San Diego,
DURING THE PERSONALIZED MEDICINE WORLD CONFERENCE (PMWC) that took place in Silicon Valley last week, there was much excitement about the earliest clinical services that meet the definition of personalized medicine.
It won’t surprise pathologists and lab administrators to learn that companion diagnostics is considered a frontline example of personalized medicine. Our Editor-In-Chief, Robert L. Michel,
CEO SUMMARY: In September, Palmetto, a Medicare carrier serving California and seven other states, made public two draft local coverage determinations (LCDs) that revamp its coverage guidelines for molecular diagnostic tests (MDT) and laboratory-developed tests (LDT). All labs submitting claims to Palmetto would need to apply to Palmetto for each MDT or LDT it plans