Devices & Diagnostics

Meridian Bioscience to release up to four new illumigene tests in next year

Meridian Bioscience (NASDAQ:VIVO) plans to launch up to four new tests from its illumigene molecular diagnostic testing platform over the next year. Cincinnati-area Meridian is betting big on the illumigene platform, which it says provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the […]

Meridian Bioscience (NASDAQ:VIVO) plans to launch up to four new tests from its illumigene molecular diagnostic testing platform over the next year.

Cincinnati-area Meridian is betting big on the illumigene platform, which it says provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation.

The first expected new illumigene test will be for Group B streptococcus, a bacterial infection that pregnant women can pass on to newborns. CEO Jack Kraeutler said the company was awaiting U.S. Food and Drug Administration clearance to market the test, according to a statement accompanying the company’s fourth-quarter earnings data.

Other new versions of the illumigene test include those for Mycoplasma pneumonia, an infection of the lungs; Group A streptococcus, a type of bacteria often found on the throat or in the skin; and Pertussis, a contagious bacterial disease that causes whooping cough.

“Longer term, our business is dependent upon technological innovation that can improve diagnosis and detection while materially reducing the total costs of healthcare,” Kraeutler said.

Meridian’s first illumigene test, for the bacterium C. difficile, received FDA approval in July 2010. It’s the only test from the illumigene platform that’s received market clearance in the U.S. During the quarter, Meridian added 150 “placements” of the test for a global total of 650, Kraeutler said.

Turning to financials, the company reported a 26 percent increase in fourth-quarter earnings to $6.7 million. Adjusted earning per diluted share came in at 18 cents, a penny below the consensus analysts’ estimate.

Fourth-quarter sales jumped 16 percent to $41 million.

For the full year, Meridian reported adjusted earnings per diluted share of 69 cents, which also fell a penny short of analysts’ expectations.

Meridian reaffirmed its full-year 2012 guidance of diluted earnings per share in the range of 85 cents to 89 cents.