Molecular Diagnostics
On June 13, the Supreme Court issued its long-awaited decision in Association for Molecular Pathology v. Myriad Pharmaceuticals, Inc. In a 9-0 decision, the Court ruled that naturally occurring human genes are not patent-eligible subject matter under the U.S. Patent Act, but cDNA can be patented. The Court did not address Myriad patents covering genetic testing methods based on specific mutations in human genes. The full decision is available online. The Myriad decision has caused a fair degree...
The following 10 names are the molecular-diagnostics industry’s heaviest hitters. Listed in descending order, these 10 firms brought in the greatest molecular-related revenues in 2012. (Update May 15, 2013: An error regarding Digene's ownership has been corrected.) If you follow this industry, there won’t be any enormous surprises here. Bruce Carlson, Publisher, Kalorama Information, points out that these are the 10 companies “that have almost always showed up” on the...
  HiberGene Diagnostics CEO Tony Hill As part of our new monthly series on emerging IVD companies, IVD Technology spoke with Tony Hill, CEO of HiberGene Diagnostics Ltd., a young company based in Dublin, Ireland. Hill's company has developed a rapid and highly sensitive molecular diagnostic test for bacterial meningitis, which the company hopes to introduce to the European market in Quarter 4 of this year, with a U.S. introduction a year later.   Please give us...
The basic promise of personalized medicine is predicated in large part on the expanding availability of biomarker-based testing, and FDA-approved tests offer the broadest market for any biomarker that is to be developed into an IVD. Approval trends for biomarker-based IVDs are thus among the best objective measures of progress in advancing personalized medicine. A new report that reviews trends in approvals of 510(k) and premarket approved molecular IVDs shows an appreciable decline in the...
Appropriate early treatment of hospital-acquired infections (HAI) has been associated with lower treatment costs and improved patient outcomes. Current culture-based methods for diagnosing HAI are either slow or poorly sensitive/specific; therefore, broad-spectrum antimicrobial therapy is often initiated when there is clinical suspicion of infection. This approach may not be effective when dealing with inherently resistant organisms and can result in iatrogenic infections. Amplification and...
Molecular methods have revolutionized the way clinical labs identify the presence of microorganisms in patient samples, monitor viral responses to therapy, and characterize genetic disorders. Challenges with traditional techniques include difficulty growing organisms with prepared media or in cell culture, slow or poor growth kinetics in vitro, limited sensitivity, and the labor and technical expertise requirements associated with manual methods. The molecular diagnostics industry continues to...
We are entering a bold new period for personalized medicine and molecular IVDs, highlighted by the AMA’s approval of more than 100 new genomic test codes for 2012. But there are still some urgent problems in our regulatory and reimbursement policy arenas. The regulatory problem is the disincentive that our mixed environment of approved IVDs and competing laboratory-developed tests (LDTs) impose on IVD companies that make long-term investments in product development and FDA submissions...
Image: Lumora Ltd. Recent updates to HIV treatment guidelines have revealed a trend toward earlier treatment and highlighted the longer life expectancy being seen in the HIV population.1-3 Collectively, these two factors mean that patients are receiving antiretroviral therapy (ART) for longer than ever before. In the developing world, efforts to scale up treatment of HIV have led to increases in the proportion of patients receiving combination ART (cART).4 However, in areas where...
Diarmuid Flavin, CEO of Biosensia, has 15 years of management experience in the healthcare industry, from diagnostics to medical devices and sterile parenteral pharmaceutical manufacture. Previously, he was quality operations manager for cardiac therapies at Abbott Vascular. Flavin is a graduate of the National University of Ireland and holds an MSc in pharmaceutical manufacturing technology, a higher diploma in QA assurance, and a BSc in microbiology. Irish startup Biosensia will...
  Shopping for parts, components, services, and new technologies at the Clinical Lab Expo next week? You're in luck. Here's just a tiny sampling of what will be on display there. Isolation Miniature Valves Solenoid-operated valves use a flexible diaphragm to isolate the solenoid actuation mechanism from the fluid path. When the valve is energized, the solenoid retracts an armature that is attached to a flexible diaphragm. In a normally closed valve, this raises the diaphragm, allowing...