Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This rule would expand APRNs’ authority, currently limited to ordering and interpreting lab tests. In an
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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.
CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has identified 10 ways that it can contribute more value to physicians and its parent health system. One way is to help eliminate needless tests and processes. Other initiatives involve improving supplier processes, helping to reduce patient length of stay, creating a lab test formulary, and demonstrating the financial efficacy of all lab interventio
CEO SUMMARY: For clinical laboratories and anatomic pathology groups willing to adapt to the evolving needs of the American healthcare system, there are many positive opportunities. That’s the view of a Wall Street investment bank that just published a report on the lab testing sector. The report on healthcare trends includes commentary about developments in cancer care, acceptance of personalized medicine, and the growing activity in direct-to-consumer lab testing.
CEO SUMMARY: It’s a case of the little fish gobbling the big fish, as Opko Health—with revenue of $91 million—will be acquiring Bio-Reference Laboratories, with revenue of $832 million. But the more interesting aspect of the story is that the CEO of Opko Health is a physician worth $5 billion and highly respected by Wall Street. It could be that Bio-Reference CEO Marc Grodman, M.D., has gained a shrewd advisor and powerful ally in Phillip Frost, M.D., the Chair and CEO of Opko Health.
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the clinical trial data required to obtain coverage guidelines and
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs recognize that fee-for-service reimbursement is on the way out. They want to get
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tests that are used by healthcare professionals
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
“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