Jul 18, 2012 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
New lab test market could open up if research findings lead to a useful clinical laboratory test that predicts prostate cancer recurrence
Over the past decade, clinical laboratory tests that can predict the occurrence or recurrence of breast cancer have opened up a profitable market for the companies that developed these technologies. Now, new research may become the basis of a useful medical laboratory test that could be predictive of prostate cancer relapse.
Of course, pathologists know that several years of further development and regulatory approvals will be needed before this research produces a lab test for clinical use that can reliably predict the recurrence of prostate cancer. What makes this development exciting is that there is a huge and untapped demand to help men with prostate cancer and their physicians make informed decisions about treatment options and long-term prognosis. (more…)
Jul 16, 2012 | Laboratory Hiring & Human Resources, Laboratory News, Laboratory Operations, Laboratory Pathology
It’s been a challenging year for this New Zealand city’s medical laboratory testing professionals
CHRISTCHURCH, NEW ZEALAND—Two private clinical laboratory companies in this city have had quite a roller coaster ride during the past 18 months. Included in the ups and downs were a series of destructive earthquakes, a new contract bidding cycle that eliminated one of the two existing private medical laboratory companies, and a lab acquisition.
For pathologists and clinical lab administrators in other countries, there are useful lessons to be learned in the aftermath of the Christchurch earthquakes. Among other things, one clinical laboratory company needed to move its testing facility six different times in a year! That’s because aftershocks and ongoing engineering inspections revealed significant damage to these different buildings at different points in time.
Two Major Earthquakes within Six Months in Christchurch
It was September 4, 2010, when a magnitude 7.1 earthquake rocked the city, causing considerable damage but no fatalities. Just six months later, on February 22, 2011, a magnitude 6.3 earthquake hit Christchurch. This second earthquake caused substantial damage and loss of life. For this event, experts noted that the “intensity and violence of the ground shaking was measured to be… among the strongest ever recorded globally in an urban area.” (more…)
Jul 13, 2012 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
District Health Boards in New Zealand use medical laboratory test contracts as one way to control cost of testing and better manage utilization
HAMILTON, NEW ZEALAND—Medical laboratory testing in this mid-sized city is carefully divided between a community laboratory company and the cluster of hospitals located in and around Hamilton. The test menu offered by each clinical laboratory is defined by contracts negotiated with the individual District Health Boards (DHB) that manage the healthcare system in this region of New Zealand.
This week, your Dark Daily editor, Robert L. Michel is in New Zealand. He is visiting clinical and pathology laboratories in two cities and speaking at the 2012 Pathology Laboratory Meeting that is conducted annually by Canterbury Health Laboratories (CHL), located in Christchurch. (more…)
Jul 11, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Both pathology profession and biotech industry have much at stake in how Supreme Court rules in this important case involving the patentability of genes
Legal challenges to gene patents are a high interest topic among pathologists and clinical laboratory scientists who perform genetic testing. Two high profile cases involving gene patents were accepted by the Supreme Court. A ruling was made in one case and the second case is continuing.
The Supreme Court issued a ruling in one case, titled Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Prometheus). The dispute centered upon Prometheus’ method patents to testing for metabolites of the drug thiopurine in patients with gastrointestinal disease.
In a unanimous opinion, the Supreme Court ruled that these patents were invalid. Some medical laboratory scientists believe that the ruling could ultimately result in the invalidation of the even more significant gene patents, including those gene patents at issue in Association for Molecular Pathology, et al. v. Myriad Genetics (Myriad)..
New Ruling Has Huge Significance for Pathology and Lab Medicine
According to a story in CAP Today, in the Prometheus case, the court reasoned that a process of recognizing and reciting a law of nature is not patentable because laws of nature are not patentable.
This summer, the Supreme Court will hear oral arguments in the case of Association of Molecular Pathology vs. Myriad Genetics. At issue is the patentability of genes. In March, the Supreme Court ruled unanimously against Prometheus in another case involving gene patents. (Image by PSmag.com)
“We have the first clear statement by the Supreme Court—and by a unanimous Supreme Court—that laboratory testing really amounts to nothing more than an observation about the correlation between an analyte and a particular medical condition is not patentable,” stated Jack Bierig, JD, Partner with Sidley Austin in Chicago, in the CAP Today article.
Bierig observed that the key question presented by Prometheus is where to draw the line between a law of nature and an application of the law. “There is a well-known distinction between laws of nature—which are not patentable; and applications of laws of nature—which are patentable,” he stated. “This is the first Supreme Court case that has addressed that question in the context of laboratory testing.”
The ruling overturned the U.S. Court of Appeals for the Federal Circuit (CAFC) decision which upheld the Prometheus patents.
Prometheus Decision May Render Myriad Gene Patent Claims Invalid
Important questions still remain about the patentability of genes. Just six days following the March 20, 2012, ruling in Prometheus, the Court remanded Myriad to the CAFC for reconsideration under the new ruling. In 2011, the CAFC found in favor of Myriad.
The Myriad case originated in 2009 when several plaintiffs, including the American Civil Liberties Union, filed a lawsuit challenging seven of Myriad Genetics’ (NASDAQ: MYGN) patents on the BRCA1 and BRCA2 genes and methods for interrogating the genes.
The question of gene patentability is of critical importance to pathologists, according to Roger D. Klein, M.D., J.D., a molecular pathologist and Chair of the Professional Relations Committee of the Association for Molecular Pathology (AMP). Klein observed in CAP Today that enforcement of gene patents in Myriad has interfered with pathologists’ ability to provide comprehensive interpretations involving multiple diagnostic test procedures. He asserted that the patents have also prevented pathologists from implementing cost-saving algorithms that reduce unnecessary testing.
“It’s the gene patents that are so universal,” agreed Wayne W. Grody, M.D., Ph.D., Professor of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the University of California School of Medicine. “We really care much more about the impact of this case on Myriad and other cases that may come later,” stated Grody, who is also President of the American College of Medical Genetics and Genomics.
Biotechnology in a “Minor Panic” Following Prometheus Ruling
According to a story in The Economist, the biotechnology industry is in a “minor panic” at the implications of the high court’s unexpected ruling in Prometheus.
Klein rejects the biotechnology industry’s argument that patent invalidation will jeopardize the advancement of personalized medicine. “I think it will produce tremendous advancement and accelerate progress,” he stated.
John H. Noseworthy, M.D., President and Chief Executive Officer of Mayo Clinic, agreed. “[The new ruling] will favorably impact patient care because it provides broad access to good-quality bedside testing,” he stated in a story published by The Wall Street Journal.
At this point, oral arguments in the Myriad case are scheduled for this summer. In reconsidering the Myriad case, the CAFC may reverse its previous ruling upholding the BRCA gene patents, Bierig speculated. Or, the case may end up in the Supreme Court for final determination.
“I think there’s a chance that the Supreme Court could now rule that the product of the genome is basically a natural phenomenon,” observed Bierig. Klein agreed, suggesting that the Prometheus decision probably renders the Myriad patent claims invalid.
Pathologists and clinical laboratory managers will want to continue to follow the surprising developments in these clinically-relevant patent cases. The Prometheus decision sent a clear message that the Supremes are positioned on the side of the “medical” rather than “commercial” ethic in the area of genetic patents.
For its part, the biotechnology industry may ultimately have to resort to seeking relief through congressional revision of patent law as it pertains to genes. Of course, it can be expected that the clinical laboratory testing profession would be actively educating Congressman should there be consideration of such legislation.
—Pamela Scherer McLeod
Related Information:
For background on the patent cases:
Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics
By Zeus! Prometheus ruling checks patents
Prometheus unsound: America’s Supreme Court wallops the biotech industry
Top Court’s Patent Rejection Alarms the Biotech Industry
Jul 9, 2012 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, News From Dark Daily
Pre-authorization for therapeutic drugs is one step on the path to payers requiring similar pre-authorization for expensive clinical laboratory tests
It’s a step on the road to pre-authorization for both certain therapeutic drugs and expensive genetic tests. Blue Cross Blue Shield of Massachusetts (BCBSMA) recently announced that it would work to curb drug abuse through a new pre-authorization program for certain prescription drugs.
Clinical laboratory managers and pathologists should take this as a sign that managed care plans are increasingly willing to tackle issues associated with unnecessary utilization by implementing pre-authorization requirements, among other strategies.
At the top of the pre-authorization list for BCBMSA will be such drugs as Oxcycontin, Percocet, and Vicodin. In recent years, the medical laboratory industry has watched the increase of pain management testing by physicians who treat patients taking these types of addictive drugs. (more…)
