Feb 17, 2012 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement
Court rulings in several controversial patenting cases are largely consistent
Recent decisions from the U.S. Court of Appeals for the Federal Circuit (CAFC) offer some much-needed clarity in the controversial issues surrounding the legality of life sciences patents.
This will be of interest to pathologists and medical laboratory managers, because many clinical laboratories and pathology groups must pay royalties to patent-holders for rights to use the technologies. There are multiple legal cases winding their way through the federal court system, so legal decisions in these cases have the potential to change in status quo in patent law.
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Apr 22, 2011 | Laboratory Pathology, News From Dark Daily
At issue is ability of biotech companies to hold patents on genes that might be used in clinical laboratory testing
Patents involving human genes have always been controversial among pathologists and clinical laboratory managers. This is one reason why many in the medical laboratory testing industry are following the progress of the well-publicized lawsuit that challenged certain patents involving human genes that are held by Myriad Genetics, Inc. (Myriad), of Salt Lake City, Utah.
In the trial, which was conducted last year, a federal judge ruled against Myriad Genetics. The company filed an appeal and, on April 4th, the United States Court of Appeals for the Federal Circuit (Court of Appeals) heard oral arguments in the case of Association of Molecular Pathology (AMP) (plaintiffs) versus United States Patent and Trademark Office (USPTO) (defendants). This lawsuit was originally filed on March 29th, 2010, in the United States District Court Southern District of New York (District Court).
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Feb 23, 2011 | Digital Pathology, Laboratory News, Laboratory Pathology
Goal is to produce accurate sequence of one human cancer cell; could lead to new cancer tests
Pathologists and clinical laboratory managers will find the latest “prize” for a genetic breakthrough to have direct relevance to molecular diagnostics. One million dollars will go to the first person who sequences an entire cancer cell genome, including all of the RNA, using a specific whole human genome sequencer made by Carlsbad, California-based Life Technologies (NASDAQ: LIFE).
This is the fourth of seven challenges being put out to the public at large. It is part of the global biotechnology company’s crowdsourcing initiative, dubbed the “Life Grand Challenges Contest.” Life Technologies first announced the contest in December of 2010, and since then, has posed three earlier challenges, each one also paying $1 million upon completion and verification.
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Jan 3, 2011 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Pathology
High-Density Sequencing Chips Will Soon Be Able To Sequence Five Million SNPs
Rapid gene sequencing is catching the interest of progressive anatomic pathologists. These medical laboratory professionals are interested in using rapid gene sequencing technology to allow them to study tens and hundreds of genes on a patient specimen.
The technologies used in rapid gene sequencing are being developed and improved by a handful of biotech companies who are racing each other be first to deliver systems to the marketplace that can sequence whole human genomes at a cost of $1,000 or less. Some innovative medical laboratories are beginning to acquire these sequencing systems and explore how they might be used for clinical pathology laboratory testing. (more…)
Dec 20, 2010 | Laboratory Instruments & Laboratory Equipment, Laboratory Pathology
Medical Laboratory Test Offers Improved Accuracy and Faster Time-To-Answer
It’s big news when an international health body endorses a new proprietary clinical laboratory test. That’s why pathologists will be interested to learn that, earlier this month, the World Health Organization (WHO) publicly recommended that nations incorporate a new rapid molecular test for tuberculosis into their disease testing programs.
The clinical laboratory test that the World Health Organization endorsed is the Xpert MTB/RIF test manufactured by Cepheid (Nasdaq: CPHD), the molecular diagnostics company based in Sunnyvale, California. The assay is a 100-minute rapid tuberculosis (TB) test. It is a fully-automated nucleic acid amplification test and WHO advised that the assay be introduced into clinical use under defined conditions as an integral part of a nation’s program to diagnose and treat TB and multi-drug resistant TB. (more…)
