Polymedco's automated immunoassay fecal occult blood test system receives FDA clearance

Polymedco, Inc. today announced that the U.S. Food and  Drug Administration (FDA) has granted 510(k) clearance of the OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT) used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and colitis.  

The new OC-Sensor Diana system measures 280 FIT samples per hour and ensures that quality data is consistently collected.  In addition, its compact design, only 24.8" by 22" by 22" and 133 lbs., is ideal for workstation set-up.

"If detected early, colorectal cancer deaths are preventable," said Drew Cervasio, President of Polymedco.  "We have seen increased compliance from patients, physicians and laboratory professionals using FIT and less false positive test results than other methodologies.  This feeds more of the right patients to colonoscopy.  Early detection of colorectal cancer leads to better patient care and improved survival rates, and less invasive and less expensive treatments.  Catching colorectal cancer early reduces the cost of the overall management of disease to our healthcare system. In this regard, Polymedco is truly changing the outcome of colorectal cancer."

The FIT system screening method provides increased sensitivity and specificity over traditional screening methods. Indicated for use in routine physical examinations, the test measures the presence of human hemoglobin in a patient's stool.  The results assist physicians in recommending patients to colonoscopy, leading to the detection and treatment of colorectal cancer at an earlier stage.  

Personal use iFOBT packs allow the patient to easily collect a sample and return it to the lab for quick and accurate results. The iFOBT requires no dietary or medicinal restrictions and only a single sample collection, making it easier and more comfortable for use versus other methods.