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Utilizing the fecal immunochemical test in a CLIA waived physician office lab

June 17, 2014

Colorectal Cancer, when discovered at its earliest stages,  is the most preventable and curable of all cancers. Routine CRC Screening is  important, and Pinnacle BioLabs is leading the way with Quantum - the MOST effective mass screening protocol for Colorectal Cancer.

In February 2009 the American College  of Gastroenterology, with a dramatic change of direction, released its first  update in CRC Guidelines in almost a decade. 

“The American College of Gastroenterology supports the joint guideline recommendation that older 

guaiac-based fecal occult blood tests be abandoned as a method for CRC  screening…..the ACG

recommends the FIT as the preferred cancer detection  test.”


To view complete ACG article click on the “ACG” link in the downloads section.

FIT with Quantum RRS4 technology is rapidly becoming the method  of choice for colorectal cancer screening - Easy to perform, easy to result, no more costly mailers - that may or may not be returned - and registered nurses waiting to help your patients are a phone call away.  

In comparison with guaiac-based testing, the Second Generation FIT has a  higher specificity due to its unique combination of monoclonal and polyclonal antibodies that are specific to human hemoglobin, unlike guaiac-based tests that also detect peroxidase activity and animal blood from food. 

Therefore, traditional abstinence of food and  drug by patients is no longer necessary.

In comparison with older first generation tests - readability is greatly improved, evidenced by our over-the-counter designation from the FDA - meaning that the lay person has a low propensity to misinterpret the test.

Additionally - with our Quantum system, the overall number of patients performing the received test kits spiked from 62% to over 93%.  Some people are unwilling or simply forget to put a test in the mail or return it to their physician.  Now the patient can send their FIT results electronically and instantly.  Additional benefits to you and your staff are a simple concise report, no more time wasted on resulting immunoassay tests - and most importantly - Pinnacle tracks and follows up with your patient when we have not received their results back within 5 days of the patient receiving the test.

Reimbursement remains unchanged, with providers reporting 82274QW or G0328QW with V76.41 (screening for a colorectal neoplasia).