Meridian Bioscience has filed an application for federal regulatory approval of a next-generation molecular test that detects a type of bacteria that causes damage to the digestive system.
Meridian’s illumigene test is designed to find traces of C. difficile, a bacteria that can cause life-threatening inflammation of the colon and most often affects elderly people after they’ve used antibiotic medications, according to a statement from the company.
Meridian’s application to the Food and Drug Administration marks a key milestone for the company, because the test is its first built on a new technology platform. The illumigene test is performed at the molecular level and allows for detection of bacteria without using expensive equipment. It is capable of detecting a single bacterium in a tiny sample.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Meridian currently has a test for C. difficile on the market, but sales have begun to stagnate due to increasing competition. The illumigene test is superior to the existing test because it’s faster, cheaper and can be performed on a smaller sample.
In a January interview, Meridian’s Chief Executive, Jack Kraeutler, estimated that the illumigene test could bring the company $10 million to $20 million in annual sales. The test kit works by amplifying DNA samples via technology licensed from Eiken Chemical Co. of Japan. The company began clinical trials of the test kit in January.
The illumigene test is performed on a stool sample and can be completed in less than an hour, according to Meridian.
Last week, Meridian cut its earning outlook for the year, saying that sales of test kits for upper-respiratory infections had “collapsed” because of the abrupt end of the H1N1 pandemic in early December.
