Luminex shares blossom after xTAG approval

Austin based biological testing company Luminex saw a sharp increase in its shares after it got the approval for the FDA approval for the xTAG Respiratory Virus Panel that can simultaneously detect 12 viruses and viral subtypes.

The 12 viruses which can be detected by the panel are responsible for more than 85% of viral infections known to humans. These include adenovirus, rhinovirus and the strain of influenza that has been a major factor in epidemics. The test analyzes genetic material found in secretions from the back of the throat.

Shares of the company rose by 79 cents or 4.9% on NASDAQ to reach $17.02. The stock also hit a 52-week high of $17.87 during the day’s trading. Luminex’s total sales for 2006 were $53 million.

Luminex mainly manufactures and sales bioassay consumables and devices to clinical research companies including Celera Group, Abbott Labs and Bayer.

According to the company, almost 1 million respiratory tests are conducted every year making this around a $75 million business. With this panel, tests can be completed in a matter of hours compared to week-long wait by other tests.

It is the first multiplexed nucleic acid test for respiratory viruses cleared by the FDA for in vitro diagnostic use. It also is the first test of any kind cleared to detect human meta-pneumovirus, for influenza A subtypes H1 and H3, and the first molecular test cleared for adenovirus.

"It's going to take the guessing game out of respiratory diagnosis," said Patrick J. Balthrop, Luminex President and CEO.

The Viral Panel uses the xMAP molecular diagnostic platform, to directly look into the molecules that cause disease, i.e. DNA and proteins. It also helps the researchers to observe how drugs interact with these molecules.

The most important feature of Luminex’s xMAP platform is that it can check for 100 different types of molecules simultaneously even in the impure samples. The Viral Panel uses microscopic beads that change color when they get attached to the DNA from any of the 12 different viruses, the process known as Hybridization.

"Nucleic acids tests such as the xTag Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel Schultz, director of the FDA's device center.

This test will definitely reduce the time for the tests and doctors will be able to prescribe medicine with precision.