Roche Launches New SP116 Antibody to Aid in Prostate Cancer Diagnosis

Roche Launches New SP116 Antibody to Aid in Prostate Cancer Diagnosis

Roche says clinicians can now access its anti-p504 (SP116) antibody to help diagnose men with prostate cancer, representing a new way to detect the disease early using a simple laboratory assay.

SP116, a monoclonal primary antibody, recognizes specific regions of a protein called α-methylacyl-CoA racemase (AMACR) — a useful biomarker in prostate adenocarcinoma due to its increased protein expression compared to healthy prostate tissues.

The novel antibody can efficiently diagnose prostate cancer when used in combination with the VENTANA Basal Cell Cocktail, which detects the proteins 34ßE12 and p63. The effectiveness of this method reduces the need for multiple tissue samples to achieve a proper diagnosis.

The SP116-VENTANA cocktail can therefore be especially useful when limited tissue sample is available, which is frequently the case with prostate biopsies.

“As the second most common cancer in men, prostate cancer is a serious public health concern,” Ann Costello, head of Roche Tissue Diagnostics, said in a news release. “The anti-p504s (SP116) Primary Antibody is an important tool to aid clinicians in making a more accurate diagnosis with a smaller tissue sample.”

SP116 is intended for lab diagnostic use only by qualified clinicians.

Some 1.1 million men worldwide have prostate cancer, a disease that accounts for 15 percent of all cancer types in men. Patients with prostate cancer experience several urinary and reproductive symptoms, including pain during urination or ejaculation, pain in the lower back, hips, or upper thighs, weakness or numbness in the limbs, and erectile dysfunction.

The mechanisms underlying the development of this disease are not completely understood, but several studies have suggested that genetics plays an important role in patient susceptibility. Inherited DNA mutations cause 5 to 10 percent of prostate cancer cases.

Standard procedure for detecting prostate cancer includes a serum analysis for prostate-specific antigen (PSA), a urine analysis for prostate cancer antigen 3 (PCA3), and a tissue analysis for AMACR.