Prometheus Validates Anser VDZ Assay for Use in IBD Patients

Prometheus Validates Anser VDZ Assay for Use in IBD Patients

Prometheus Laboratories has validated its novel Prometheus Anser VDZ assay to monitor adult patients with inflammatory bowel diseases (IBD), including patients with moderate-to-severe active ulcerative colitis (UC) and Crohn’s disease (CD) who are being treated with Entyvio (vedolizumab).

“Prometheus Anser VDZ uniquely measures both serum drug concentrations and antidrug antibody levels of vedolizumab from a single serum sample that may be obtained at any time during treatment,” Tharak Rao, MD, vice president and chief medical officer at Prometheus Laboratories, said in a press release.  “Prometheus Anser VDZ is a drug-tolerant assay that overcomes the limitations of assays that cannot measure both serum drug concentrations and antidrug antibody levels, even in the presence of vedolizumab,” Rao said.

Prometheus Anser VDZ is the latest test of a broad set of quantitative monitoring assays developed to provide healthcare providers with a test to measure and monitor both the levels of drug and anti-drug antibodies during therapy. Prometheus assays provide important treatment guidance, which may help clinicians in making decisions while treating their IBD patients with Entyvio or anti-TNF agents, including Remicade, Remsima or Inflectra (infliximab), infliximab biosimilars, and Humira or Exemptia (adalimumab).

Incorporating drug monitoring in clinical decisions may clarify which factors are contributing to a patient’s loss of response, helping clinicians determine an appropriate course of action.

“Nearly 100,000 patient experiences with the Prometheus Anser tests have been completed to date,” Rao said.  “Prometheus Anser VDZ is a new monitoring test that helps healthcare providers optimize clinical response to vedolizumab in adult patients with inflammatory bowel disease.”

Entyvio is a humanized immunoglobulin G1 monoclonal antibody commercialized by Takeda Pharmaceuticals. It has the capacity to bind specifically to α4β7 integrin, which is a primary mediator of gastrointestinal inflammation.  The monoclonal antibody alleviates gastrointestinal inflammation by selectively inhibiting the entry of inflammation-promoting lymphocytes into the gastrointestinal tract without blocking systemic adaptive immunity.

The U.S. Food and Drug Administration approved Entyvio injection in 2014 to treat adult patients with moderate-to-severe UC and adult patients with moderate-to-severe CD when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have been ineffective.