Medical Device Daily

3M Diagnostics (St. Paul, Minnesota), a new business unit of 3M, unveiled in early March (Medical Device Daily, March 13, 2007), introduced its first product last week, in Europe, at the 17th European Congress of Clinical Microbiology and Infectious Diseases in Munich, Germany.

This first product, launched last week and designed for hospitals fighting the battle to stop the spread of methicillin-resistant Staphylococcus aureus, is the 3M BacLite Rapid MRSA test. 3M said it is the first rapid culture-based test that can "effectively and reliably" detect the presence or absence of MRSA in high-risk patients within five hours.

"[MRSA] is not symptomatic, so this is a test for screening to determine if they are carriers of MRSA," Angela Dillow, global business manager for 3M Diagnostics, told Medical Device Daily. "It's preventative in nature."

Dillow said that typically patients are screened when they arrive at a hospital to determine if they are carriers. Or, if a patient is a "known carrier," she said, upon readmission that patient is tested again to determine if he or she had cleared the infection.

"There are several places they are tested in the body, but [clinicians] are not looking for active infections," she said. "They're looking for carriers."

One of the "most common" locations on the body is in the nose, she said.

3M said that the new 3M BacLite Rapid MRSA Test will help clinicians quickly identify MRSA-colonized patients so they can proactively manage carriers. Importantly, the company said, a confirmed negative test result is available within five hours, and a confirmed positive result is available in 24 hours.

Currently, a typical culture test would take two to three days to provide a result, Dillow said.

Hospitals would be required to buy 3M's instrument system to run the assay, but more tests are planned as applications for the instrumentation in the future, Dillow said.

The BacLite test requires 45 minutes total hands-on time for 45 specimens, which 3M said helps the laboratory's efficiency and productivity. Also, the company said it is an easy system to implement, because it does not require a high level of skill to operate.

"It also has an objective endpoint, which means that the opportunity for error is reduced," the company said.

Dillow said that molecular testing is another alternative to culture, but those tests tend to be more complex and more expensive than culture-based tests.

3M's Director of Microbiology at the diagnostics unit, Steve O'Hara, said, "The BacLite MRSA test represents a revolutionary step in microbiology testing. It is quick and simple to use due to its accelerated culture-based detection of micro-organisms direct from clinical specimen."

MRSA is one of the most common hospital-acquired infections in Europe. Among Germany, UK, France, Italy and Spain, prevalence rates range from 21% to 44%, according to the company. It said that in some European countries, the proportion of MRSA infection in patients in intensive care units is more than 60%.

In the UK, for example, it is estimated that MRSA infections are costing 11.5 billion ($2 billion) a year.

Dillow said that Europe is not homogeneous and due to this diversity, "parts of Europe have been tackling the problem many years in advance of what we have in the States and in other European countries." However, while some EU countries are "further along in thinking about this problem," MRSA is "not any less or more of a problem than in the U.S."

The expectation is that earlier screening will result in less spread of the infection and lower costs associated with isolating patients suspected of carrying the bacteria, because typically the wait is about 48 hours until confirmatory tests are obtained.

When the organization of 3M Diagnostics was first reported by the company last month, Dillow told MDD at the time that she expected three tests in the U.S. to be launched later this year, although they still require approval from the FDA.

In addition to tests for MRSA, 3M expects to develop tests of influenza A and B, along with its initial strategy to provide products in the area of infection control.

"MRSA is the top antibiotic-resistant pathogen of concern, so it's considered a great first step into the marketplace," Dillow said.

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