Ever since I founded Metametrix Clinical Laboratory in 1984, innovation in nutritional, gastrointestinal, and metabolic testing has been one of my primary goals. I have always believed that the 1st step in treating most health conditions is to determine the underlying reasons for altered function through targeted testing. Our goal at Metametrix was to deliver a full range of tests that would provide this information. Over almost three decades, we have been honored to play a role in helping clinicians discover the value of functional laboratory analysis in treating disease and promoting health. In the summer of 2012, the integration of two innovative companies, Metametrix and Genova Diagnostics, created an even stronger platform to advance the increasing recognition of this powerful testing paradigm.
Over the years, both companies had focused independently on testing the inner world of the human gut. Genova continued to refine the proven culture techniques for stool testing, while Metametrix concentrated on developing PCR technology. DNA analysis represented a true advance in assessing the microbiome; this has been underscored by the rapidly amassed (and amassing) body of scientific publications on molecular techniques – and the increasingly demonstrated associations between altered gut microflora and human illnesses, such as IBS, IBD, and autoimmune disorders. The foresight of this focus on stool testing is now being reinforced by research from the Human Microbiome Project at the National Institutes of Health. Now that our two companies have merged, a top priority is refining our test profiles to advance the science of gastrointestinal diagnostics. Combining Genova’s expertise in gold-standard stool-testing techniques with the cutting-edge DNA methods advanced by Metametrix for identifying hard-to-culture gut bacteria produces the perfect marriage of technologies.
And I’m very pleased that our innovation continues. Since the integration, the joint scientific (Laboratory) and Medical Affairs teams continue to make a phased series of changes to increase the clinical utility of the GI Effects Gastrointestinal Function Profile, while also expanding the options for insurance coverage. To that end, a new version of GI Effects—GI Effects 2200—debuted on October 28th.
My original motivation for developing PCR methods was to solve the challenge of identifying gastrointestinal bacterial populations more completely, since the vast majority of gut bacteria are anaerobic and will not culture in standard aerobic culture environments. DNA technology provides an effective solution and allows for significant advancement in understanding how the composition and balance of GI tract microbiota affect human health.
However, when it comes to parasites and other pathogens, the clinical utility of DNA analysis has always been less apparent. The simple presence of parasite DNA provides no information as to active infection and taxonomy often may be unidentified; therefore, the indications for clinical action are unclear. While molecular technology continues to advance in this area and we are strongly committed to that research, our immediate goal is to refine our current testing to provide the greatest diagnostic utility for the clinician. The GI Effects 2200 profile eliminates the issue of unidentifiable taxonomy by replacing PCR parasitology with Ova & Parasites (O & P) technology, which helps to increase diagnostic certainty in identifying the patients who require clinical intervention for parasites. Regarding other pathogens, because clinical utility is best achieved by applying diagnostic assessment when there is a high index of suspicion for infection, C. difficile, H. pylori, Shiga Toxin E. coli, and Campylobacter spp. will now be offered as add-on panels by enzyme immunoassay (EIA) only, allowing test-panel customization based on clinical presentation of the patient.
I’m excited by these current changes and look forward to seeing our innovation continue as we integrate fully. I know that these enhancements will help physicians achieve more-targeted clinical results and help countless patients who are still searching for answers to their frustrating chronic health problems.