A new generation test measures drug (infliximab) and drug antibody levels in one sample among inflammatory bowel disease (IBD) patients who use infliximab.

The newly launched test helps physicians to identify potential causes for loss of treatment response and helps to guide patient management decisions.

The new generation test is called Anser IFX and is a product of Prometheus Laboratories Inc., (San Diego, CA, USA). The Anser IFX test was verified with more than 3,000 IBD clinical patient samples. The test uses Prometheus' nonradiolabeled homogeneous mobility-shift assay (HMSA) to measure the antibodies-to-infliximab (ATI) and IFX levels in serum samples.

Approximately 50% of IBD patients using infliximab may eventually experience a loss of treatment response. For some patients, this loss of treatment response may be the result of insufficient infliximab levels. For others, the loss may be due to the development of antibodies to infliximab (ATI). If the loss of treatment response is due to the development of ATI, increasing the infliximab dose–the most common first step for physicians–may be less effective than switching to another treatment agent.

"The need for Prometheus Anser IFX is high, and its availability marks the latest milestone in our continuing commitment to significant advancements in personalized medicine for gastroenterologists, patients, and healthcare providers," said Joseph M. Limber, president and CEO of Prometheus.

Crohn's disease and ulcerative colitis, are chronic inflammatory conditions of the intestinal tract. Symptoms of the disease may include diarrhea, abdominal pain, fever, and rectal bleeding. Patients may require long-term medical care, including hospitalizations, surgeries and therapeutics. Sometimes the condition is difficult to diagnose, treat, and manage clinically.

Prometheus intends to use this platform for the introduction of additional tests targeted to other biologic agents being used to treat a variety of autoimmune diseases.

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Prometheus Laboratories Inc.