A Diagnostics & Imaging Week

Harmonization is one of the keys to make global commerce work, and the Securities and Exchange Commission has signed on to a protocol that will allow the agency to share information on the use of International Financial Reporting Standards (IFRS) with its counterparts in four European nations.

According to a May 23 statement at the SEC web site, regulators in Belgium, Bulgaria, Norway and Portugal will now share such data with other signatories as part of a work plan previously agreed to by SEC and the pan-European agency known as the Committee of European Securities Regulators (CESR). The agreement follows a similar arrangement with authorities in the UK.

Christopher Cox, chairman of the SEC, said in the statement that "arrangements of this kind are quickly becoming a cornerstone of U.S. securities regulation in today's global marketplace." He also noted that the German Federal Financial Authority is on board with the IFRS agreement.

SEC stated that investors in the U.S. "increasingly demand seamless cross-border access to information and capital" and that these agreements "represent an important step in our pursuit of that goal." On the other hand, foreign investment in the U.S. also is rising, adding a further sense of urgency to the effort.

FFDM display guidance finalized

Full-field digital mammography (FFDM) has changed the science of mammography, but not the problem of interpreting different image sources. However, FDA's May 30 guidance on displays and accessories for FFDM systems gives manufacturers some guidance on any 510(k) applications for those display systems.

Any application for a soft-copy display, such as a computer monitor, should include data on "the speed and bit-depth precision of digital-to-analogue converters," the guidance states, along with pixel (picture-element) parameters such as array dimensions, size and pitch.

An application for a hardcopy display system must also include data on pixel size and the minimum size of the recording pixel matrix. Spatial resolution is another parameter of interest for hardcopy.

Image archiving systems also are addressed in the guidance, which calls for data on any image data compression software that an archiving system might employ along with "data handling, storage and security features."

Heavily processed images are the order of the day, and the guidance recommends that a manufacturer include a description of how any such software functions as well as a detailed flowchart of the software's function. Manufacturers are also urged to provide a list of workstations known to be compatible with the program.

As for physical laboratory testing of softcopy systems, FDA recommends that sponsors provide data on luminance response and luminance uniformity as well as any geometric distortion known to be generated by the software. Manufacturers also will want to provide data on "chromacity ... measured at the center of the screen at 5%, 50% and 95% of the maximum luminance."

Medicare NPI number now mandatory

CMS gave all providers and suppliers of medical equipment a reminder that they will all have to use their national provider identifier (NPI) numbers in any transactions that are subject to the rules of the Health Insurance Portability and Accountability Act (HIPAA).

The May 23 notice barely qualified as timely, given that the rule went into effect that same day.

On the other hand, acting administrator Kerry Weems said this should not be news to the affected parties. "We have been working with healthcare providers and their trade and professional organizations for more than two years to get us to this point of one unique number for identification," Weems said, warning providers that any transactions "that are sent with a legacy number will be rejected on and after the May 23 deadline."

NIH scans gene-cell behavior

Seeing small is the key to much of modern medical science, and thanks to an NIH study, scientists now can visually track the interaction between genes and their host cells as they happen, thanks to a technique called live-cell fluorescent microscopy.

Fluorescence microscopes are not exactly new, but were limited to two-dimensional images in previous years. Thanks to improvements in the field of visualization and the addition of image processing computer software, scientists can capture images in real time and observe how genes transmit their codes into living proteins.

According to the May 22 announcement at the NIH web site, researchers at NIH's National Cancer Institute have seen enough from live-cell fluorescent microscopy to establish that a version of ribosomal ribonucleic acid (rRNA) known to scientists as RNA pol 1 functions in a more complex manner than previously understood. The new information may shed light on the processes behind the various forms of cancer.

The NIH statement said that RNA pol I "is not a single protein but rather a complex of subunits that assemble into the full polymerase when needed." The researchers concluded that some of the pol 1 sub-units "associate more stably with the gene and assemble active and complete RNA pol I complexes more efficiently.

To test the idea further, the scientists then interfered in the interactions between the RNA pol I subunits and another transcription factor, which was said to mimic "the conditions of a cell that was able to produce rRNA at a high rate," the NIH statement said, which the cell reacted to by drastically cutting the efficiency of rRNA output.

This outcome hints that the "efficiency with which the RNA pol I complex assembles all its subunits ... plays a significant role in determining when a given gene is turned on." If the results of this study generalize to other transcription factors "the observed may represent a general mechanism for regulating gene transcription," the statement said.