Diagnostics for Personalized Medicine
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 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...
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...
  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...
The Clinical Lab Expo will feature new science and technology in every area of clinical diagnostics, automation, information systems, point of care, OEM, and biotech. Roughly 750 organizations will occupy about 2000 booths. According to Clinical Lab Expo's Website, "You will see more products in every clinical lab discipline than at any other show." Find What You Need The Clinical Lab Expo will have special sections for special products. Visit the special sections for point-of-...
The INFORM HER2 Dual ISH DNA Probe cocktail assay was approved as an aid in the assessment of patients considered for treatment with Herceptin (trastuzumab). Image: Roche Among the American IVD manufacturers working to make personalized medicine a day-to-day reality in healthcare, none appears busier than Ventana Medical Systems in Tucson, Arizona. Since the beginning of 2012, Ventana, a Roche company, has made six announcements (at last count) of collaborations with...
Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth. The current IVD market includes immunochemistry, molecular diagnostics, blood donor screening, hematology, hemostasis, and point-of-care testing. As the IVD market evolves to become more efficient and less costly, a shift from manual testing to automated methods is essential. Furthermore, as patient care shifts from the hospital to the alternate care setting, IVD is likely to follow. Overall...
Companion diagnostics are emerging as a key part of personalized medicine. Particularly in oncology, patients are being better served by drugs for which patients are selected via in-vitro diagnostic tests. The field is promising but nascent: so far, the potential of companion diagnostics is greater than the number of drug-and-diagnostic products that is actually commercially available. To find out why this is the case, and to learn more about the future of companion diagnostics, IVD...
In the ongoing legal saga that could significantly affect the development of molecular diagnostics, the Federal Circuit Court of Appeals in Washington, DC partially reversed a lower district court’s earlier ruling in a case challenging patents on two human genes associated with breast and ovarian cancer. The appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences. “The ruling is a blow to the idea that patent law...
FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a companion diagnostic that is intended to be used with a corresponding drug. Industry analysts were positive in their overall assessments of the guidance. “The draft guidance is helpful in several...