This research study led by Dr. Javed Yakoob from Aga Khan University, Karachi, has determined that a gastric juice polymerase chain reaction test for the diagnosis of Helicobacter pylori infection has greater sensitivity compared to histology when commonly used potent acid-reducing drugs such as proton pump inhibitors are being used. The use of the gastric juice PCR test can be recommended to confirm H. pylori status in patients taking PPIs.

This study determined the efficiency of a gastric juice PCR test for the detection of H. pylori infection in patients receiving PPI therapy and compared it with histology and gastric biopsy PCR.

Helicobacter pylori (H pylori) is a gram-negative spiral bacterium that infects the human gastric mucosa and is associated with gastritis, gastroduodenal ulcer disease, gastric carcinoma, and lymphoma of mucosa-associated lymphoid tissue.

An accurate diagnosis of H pylori infection is important when seeking to cure patients with persistent gastric symptoms in which H pylori infection is suspected. In patients on acid-reducing drugs such as PPI or H2-receptor blockers (H2RB), the accuracy of the rapid urease test, urea breath test and histology are known to be lower for the diagnosis of H pylori infection.

In the view of the authors, the development of new targets to test for H pylori infection in patients with prior use of acid-reducing drugs is important, considering the morbidity and mortality associated with this infection. Gastric juice PCR has been evaluated as a highly specific and rapid method for the detection of H pylori.

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New clinical data from a study of 570 men published in the peer-reviewed Journal of Urology1 support the use of PROGENSA PCA3 as a tool for diagnosing prostate cancer. The study confirms that PROGENSA PCA3, the world’s first gene-based urine test to help detect prostate cancer, can provide clinicians with valuable information that helps guide diagnosis.

As awareness and clinical support for PROGENSA PCA3 grows, a unique new resource regarding prostate cancer has been launched. www.PCA3.org is the first patient and professional website dedicated solely to PCA3, providing patients and healthcare professionals with information about how PCA3 can be used to help tackle the UK’s most common cancer affecting males.

Launched last year in the UK, PROGENSA PCA3 addresses some of the limitations of existing diagnostic tools. For example, Prostate Specific Antigen (PSA) is commonly elevated for reasons not related to prostate cancer, and as a result, PSA testing produces many ‘false positive’ results, which can burden patients and the healthcare system. In contrast, the genetic marker PCA3 is elevated only in cancerous prostate tissue, making it a more specific indicator of cancer than PSA, potentially reducing the number of unnecessary biopsies.

“We found that the percent of biopsy-positive men identified directly increased with the PCA3 score,” commented Dr. Jack Groskopf, Director of Oncology Research and Development at Gen-Probe Incorporated and co-author of the study. “We also confirmed that the PCA3 score was independent of prostate size; this is important because PSA levels can be elevated in men who have enlarged prostates due to non-cancerous conditions.”

Men with a PCA3 score of less than five showed a positive biopsy rate of 14 percent; however, a PCA3 score greater than 100 showed a 69 percent biopsy positive rate. Results were similar regardless of a patient’s PSA levels or whether they had undergone repeat biopsies.

“PROGENSA PCA3 provides physicians with valuable information to guide biopsy decisions.” added Dr. Groskopf.

The study expands on findings from a previous study conducted by Dr. Leonard Marks of the Urological Sciences Research Foundation published in the March 2007 issue of Urology.

PROGENSA PCA3 is the first CE-Marked test to use the presence of PCA3 (a genetic marker for prostate cancer) to predict prostate cancer, and can be used in conjunction with current tests to confirm diagnosis.2-7 PCA3 is overexpressed, relative to benign cells, by 60- to 100-fold in more than 90 percent of prostate tumors. DiagnoCure Inc. (TSX: CUR) is the exclusive worldwide licensee for all diagnostic and therapeutic applications of the gene. Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November of 2003.

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