On September 9, 2020 Paradise Genomics reported that it has advanced the development of their whole blood-based assay for gastric cancer by translating a gene expression profile associated with the disease into a high-throughput and cost-effective real-time PCR (RT-PCR) test (Press release, Paradise Genomics, SEP 9, 2020, View Source [SID1234564871]). The company is currently evaluating strategic partners to help bring this early detection molecular diagnostic to the clinic.
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Each year, approximately 28 thousand people in the United States and more than one million worldwide are diagnosed with gastric cancer. One of the greatest challenges in treating this cancer is that it is difficult to detect before it’s too late – pre-cancerous changes in the stomach lining rarely cause any symptoms, and frequently, the cancer has spread throughout the body before it is even diagnosed.
"Unfortunately, late stage gastric cancer can often times be a surprise," said Dr. Gary Pusateri, Chief Executive Officer and Medical Director for Paradise Genomics. "As such, there is a real need for a blood-based clinical diagnostic that can identify the presence of cancer in the critical early stages of gastric cancer."
In the stomach, precise detection of malignant and premalignant lesions, particularly atrophy, intestinal metaplasia (IM) and dysplasia, always requires upper digestive endoscopy with tissue biopsies. Paradise Genomics, through a collaboration with Dr. Martin A. Gomez Zuleta, Associate Professor of Gastroenterology at the Universidad Nacional de Colombia and Gastroenterologist at Hospital Universitario Nacional in Bogota, Colombia, identified a blood-based gene expression profile composed of 95 genes. With greater than 90 percent accuracy, this profile is highly sensitive and specific in differentiating healthy patients (or those with gastritis alone) from those with gastric cancer or premalignant conditions. The company was able to take the identified genes and develop a rapid, reproducible RT-PCR test from a minimally invasive blood sample for the detection of cancer.
Pusateri noted, "By taking the gene expression profile from discovery to creation of a reproducible test validates our approach and process. We’re confident that with the right partner, we can make a real impact in the early diagnosis and intervention of this silent disease, as well as other diseases."
Currently, the gastric cancer RT-PCR test from Paradise Genomics is for research use only. The company will further validate the gene expression profile with additional samples prior to submission for regulatory clearance.
As a discovery-centric company, Paradise Genomics has spent the past several years, discovering accurate and novel gene expression profiles in blood and tissue, for a number of diseases, including colorectal cancer, celiac disease, fibromyalgia, depression, bipolar, ADHD, and PTSD.