We proudly claim that “WE ARE #1 IN THE BUSINESS OF #2.”
Genesis Labs provides molecular diagnostic and anatomic pathology solutions for gastrointestinal diseases. From the beginning, our goal has been to advance the current knowledge, fill the gaps in diagnosing and treating Gastrointestinal (GI) diseases and improve clinical management outcomes.
Approximately 375 million episodes of diarrheal illness occur in the United States annually. Healthcare providers experience an overwhelming 73 million consultations resulting in 1.8 million hospitalizations. Mortality figures are in excess of 3,000 deaths with over $6 billion of associated medical care and lost productivity1.
One of our main focuses has been to develop various stool tests that can help clinicians differentiate Functional Diseases from Non-Functional GI illnesses. Abdominal pain, bloating, and diarrhea are common symptoms shared by most GI illnesses. As such, the ability to differentiate between the Functional and Non-Functional etiologies is difficult and often requires various expensive and sometimes unfruitful lab tests. This can be frustrating for both the patient and the physician.
Also, it can be needlessly more expensive for the insurance company to pay the bills. With this in mind, Genesis Labs developed a comprehensive diarrhea panel that combines a selection of FDA-approved and Laboratory Development Tests (LDTs), demonstrating the ability to decisively differentiate between Functional and Non-Functional GI disorders.
Specialized Stool Testing
In addition to performing all traditional stool tests performed at most major labs, we perform several stool molecular and immunoassay-based tests that can differentiate between various diseases affecting the GI tract. Many of these are uniquely offered at Genesis Labs and are not performed at larger laboratories.
Genesis Labs has partnered with many developmental stage stool testing labs worldwide and helped with refining testing methods, validations, and clinical applications. By our estimates, we are currently the largest stool testing lab in the country, doing close to 20,000 various types of stool tests every month.
Rapid Turnaround Time (TAT)
We have taken the lead in developing and improving patient compliance with stool testing and reducing turnaround time (TAT). This has significantly increased the number of patients undergoing stool testing recommended by their physicians. We have created a very user-friendly take-home kit for sample collection. Our pre-assembled kit is handed to the patient at the time of the office visit. The kit has all the tools needed for a quick and seamless sample collection at home. The kit includes a prepaid shipping envelope for the sample to be delivered to the lab overnight. All of the physician-ordered tests can be run from the two collection vials included in the kit.
The turnaround time (TAT) for the Diarrhea Pathogen Panel (DPP) is 24 hours or less after collection, and all other test results are reported within 72 hours. Traditionally for stool testing, patients visit a lab to pick up sample collection vials after getting a prescription from the physician’s office. Then, they must revisit the lab after collecting the sample at home without using any stool collection equipment provided by the lab.
Needless to say, most patients never complete this lengthy process and forgo these very important tests requested by their physicians. Our research (2019 Genesis Labs Patient Satisfaction Survey)2 indicates that the compliance rate of stool testing with traditional labs is less than 20%, while close to 60% of patients submit a sample when our kit is given out by the physician.
Delayed and missed diagnosis can clearly add to the worsening of the illness and increased expenditure. In addition to the test we already perform, Genesis Lab’s portfolio of fecal markers in the making is geared to further differentiate between Functional and Non-functional GI disorders. These include Alpha-1 Antitrypsin, Beta defensin 2, Lysozyme, and Secretory IgA. These are all under varying stages of development and could be included in our future offerings if they demonstrate clinical utility.