Final Thoughts
Approval Trends for Biomarker-Based IVDs
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...
CLIA-Waived Tests: Continuing the Conversation
A two-tiered regulatory scheme currently imposed on sponsors of new point-of-care (POC) IVDs, particularly devices intended for the physician office laboratory (POL), was characterized as unduly burdensome in a column titled, “CLIA-Waived Tests: Is There Another Way?” published in the March/April 2010 issue of IVD Technology. In brief, a prospective sponsor of a new POL test not only must secure FDA clearance but, in many cases for marketing reasons, also must obtain CLIA...
Regulatory and Reimbursement Issues Involving Molecular IVDs
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...
RUOs: What Will an Updated Regulatory Approach Accomplish?
In the November/December 2010 issue of IVD Technology, I discussed moves made by FDA to regulate laboratory-developed tests (LDTs, formerly known as “home brews”). Examples of inadequate LDTs were formally submitted to FDA in Genentech’s December 2008 Citizens’ Petition, but the agency’s discomfort with LDTs has a long history. New guidance documents and presentations in recent months have sought to clarify FDA’s intentions and produced many responses...
Measuring Regulatory Effectiveness
After more than 35 years of industry and FDA device and diagnostic evolution, it remains difficult to measure regulatory effectiveness because we are still seeing a moving target in submission reviews and enforcement. Examples include performance testing, clinical data, and quality system regulation (QSR)-related information and claims. While the FDA-requested Institute of Medicine report published last summer called for a rewrite of the 510(k) process, in part based on perceived 510(k) process...
TB CDRC Fights TB with Diagnostic Science
  Despite UN Secretary-General Ban Ki-moon’s statement in March 2010 that “in this day and age, no one should be dying from TB,” fatal cases of TB remain a reality.1 In 2009, an estimated 1.7 million people died of TB-380,000 of whom were co-infected with HIV.2 Roughly one-third of the world’s population is infected with TB, and 10 percent of infected people are likely to develop active TB at some point in their lives.2 Development of more-effective TB tests...
Designing Medical Device Software for the Millennial
2010 was a catalyst year for computing. When Apple launched the iPad tablet computer in April, it brought the keyboard and mouse one step closer to extinction. Similarly, with Windows 7, Microsoft added true touch-screen support to desktops, tablet PCs, and smartphones. Google made an entrance as well, with Android, an operating system for smart phones and slates. Touch screen will be the dominant user interface for years to come, according to DisplaySearch.com, which monitors and reports on...
IT Innovations Raise the Bar for IVDs
Healthcare is being reshaped by IT. Some of the most influential solutions transforming the healthcare industry involve the flow of data, be it life-saving information transmitted to hard-to-reach locations following a natural disaster, or the aggregation of patient results on a single screen to accelerate actionable decision-making. The clinical laboratory environment is a relative newcomer to the widespread adoption of more sophisticated IT solutions compared to other segments of the...
AdvaMedDx Advocates for Industry
Today a nurse can test a senior citizen for C. difficile in a long-term-care facility. Within hours, the test indicates that special care is required to prevent the spread of this healthcare-associated infection. In the near future, a molecular assay may be able to detect ovarian cancer in a 45-year-old woman with persistent stomach pain, before the cancer spreads to other organs.   Advances in genetic and molecular research are leading to many new and promising technologies like these,...
Measuring Regulatory Effectiveness
When CDRH reworded the copyrighted ISO 9001 Quality Standard to update the Good Manufacturing Practice regulation in the 1990s, the primary objective was the addition of design control.1  It was reported by FDA that approximately half of all device and diagnostic recalls were due to design issues rather than manufacturing issues. Last September, the independent Battelle Memorial Institute issued a report for AdvaMed on the 510(k) premarket submission program and, among their conclusions,...