Ingen launches in vitro diagnostic kit for joint replacement infections

30 June 2010

Ingen Biosciences has launched in Europe the first in vitro diagnostic kit to detect infections in prosthetic replacements.

The diagnostic kit, BJI InoPlex, is built around Ingen Biosciences’ proprietary antigen technology. The kit consists of a panel of new high-standard antigens developed by the company. The first generation kit detects in the range of 75% of infections found in joint replacements, such as Staphylococcus aureus and S. epidermidis.

“BJI InoPlex is Ingen Biosciences’ first proprietary in vitro diagnostic product and it will open up opportunities and bring new growth to the group,” says Jean-Pierre Hermet, chairman and CEO of Ingen Biosciences. “This flagship product shows very high promise in the non-invasive detection and diagnosis of bones and joint infections, which we believe will considerably strengthen our position in the infectious diseases area.”

BJI InoPlex is the first of its kind on the market. The alternative to Ingen Biosciences’ non-invasive serological test is to put patients through a lengthy and costly surgical procedure to open up the knee joint, for example, and search for the infection. BJI InoPlex, therefore, can offer major economic benefit in detecting, treating and monitoring infection in the joint replacement process.

BJI InoPlex is the first-generation of in vitro diagnostic kits that Ingen Biosciences will make available before end of the year. Through a standard industry technology license, Ingen Biosciences has the rights to sell the kit in Europe, at first. The company plans to sell to other geographic markets in the future. The company also plans to launch a second-generation diagnostics kit in 2011 that will include new antigens to detect other infections in joint replacements.

“None of the antigens for the test kit existed until we developed them,” added Hermet. “Since infections in joint replacements is a niche market, it has tended to be overlooked by incumbents making in vitro diagnostic kits. At present, we have the market to ourselves.”

According to industry data, each year, 3.5 million joint replacements are conducted around the world with more than 1 million in Europe (source: Alcimed, a European consulting and decision aid company specialized in the fields of Life Sciences). Approximately, 15,000 prosthesis infections are reported each year in Europe, with an infection rate estimated between 2% to 3%.

BJI InoPlex uses several recombinant protein antigens developed at Ingen Biosciences to enable users to carry out several key tasks in diagnosing and treating joint infections. These include confirming or eliminating an infection from among bacteria groups that are most commonly found in bone and joint infections (staphylococcus), assessing the potential for infection by detecting the patient’s immunoreaction and enabling the biological monitoring of antibiotic treatment in patients.

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