Frequently Asked Questions

Our test works by detecting a variant mycobacteria and a metabolic (waste) product that is specific to cell wall-deficient mycobacteria (CWDM). Mycobacterium avium subspecies paratuberculosis (MAP) is one type of CWDM found more prevalently in Crohn’s disease patients.

CWDM are historically slow growing and difficult to culture. The 7DN culture media has been specifically designed by Otakaro Pathways to rapidly grow CWDM. It also allows us to detect a unique metabolic product and distinguish between mycobacterial strains.

We chose not to identify MAP via PCR or other molecular methods because MAP is present in low concentrations in human control samples as well as those with Crohn’s disease. In contrast, we have developed a test that is able to distinguish between the CWDM forms found in human controls, and variant forms seen in Crohn’s disease patients.

Variant forms are robust, viable strains of CWDM that have the potential to cause disease. We see these variant forms present in the cultures from Crohn’s disease patients, but rarely in controls. Crohn’s disease patients in remission will often show a result similar to control patients. This is because the CWDM are present in lower numbers, which results in less metabolic product produced. When the patient is in a flareup, there will be many CWDM present in the cultures, and a greater amount of metabolic product produced.

The test is conducted in two stages:

Stage 1: 7DN culture media is used to promote CWDM growth and detect variant forms. Growth promotion tells us that the CWDM are living, and able to grow in our culture media.
Stage 2: Variant forms are isolated and we promote growth with 7DN culture media.

It will confirm that you have the variant CWDM we associate with Crohn’s disease, and an estimate of the numbers present. The growth in culture allows us to use the isolate of CWDM variant forms for further testing and research

The test is run over thirty days to allow for observation of the growth characteristics. A report will be prepared shortly thereafter and sent to you via email.

Your individual 4-8 page laboratory report contains the results of your cultures and labelled photos of the microscopic features we found. We also provide an assessment of your disease status and a description ofthe media and method used.

Yes, at the present. We are in the process of validation and obtaining regulatory approval for the test. Our intention is to finalise development of the media and to make the methods widely available to diagnostic medical laboratories for patient support. Since Otakaro Pathways is dedicated to advancing research for the benefit of patients, we decided to make the test immediately available after requests from patients, clinicians and researchers.

The test can enable you to look at options for treatment, and allow you and your doctor to monitor your progress. However we do not yet advise using the test to continually monitor progress, as a clinical assessment may be of more relevance. There is still debate over the precise cause of Crohn’s disease and ulcerative colitis, but it is apparent to most commentators that the environment plays a part, along with a genetic predisposition. Research to determine whether a variant CWDM causes Crohn’s disease is ongoing.

No, the test will help to confirm that you have a variant form of CWDM capable of causing your illness which may be possible to treat using new therapies, particularly those able to treat infections or modify the reaction of the immune system. It is important that the results of the test are reviewed in the context of your diagnosis, and other clinical considerations.

Yes. We are happy to discuss the interpretation of the report with you and/or your doctor and answer any questions not covered by your report or this publication. We are in the process of publishing our work, and are collaborating with international researchers. External evaluations and methods to conduct qPCR are ongoing.

Your doctor is your avenue to the health care system, and it is important they are fully informed of your health status, the therapies you may be on (including alternative therapies), and the results of any tests you may have had. We encourage you to share your lab report with your doctor, and can provide additional publications and information to explain our methodology upon request.

The staining and culture methods we use are conventional microbiology methods. The unique 7DN culture media is designed to isolate the variant forms.

Aside from discussing the results and potential CWDM treatments with your doctor, we advise patients to stay informed of relevant clinical research on CWDM and IBD. Consider joining a patient support group to find new research and advances. Human Paratuberculosis Foundation (HumanPara.org) provides up-to-date research on mycobacteria and immune disease.

Two tubes of blood are required to complete your test. (See our website for detailed requirements.) This can be obtained from a local laboratory where they offer phlebotomy services. In some instances, laboratories are legally prohibited from handing a patient blood samples. In this case, we would recommend asking your doctor for assistance, or bringing the Otakaro Pathways lab requisition to the draw site. Private phlebotomy services near you may also be able to assist.

FedEx is the preferred carrier. Request a “Clinical Pack” which allows for easy transport. Samples do not need refrigeration, and are viable as long as they arrive within 7 days after being drawn. For more details on how to fill out shipping and customs forms, please see our website. In the unlikely event of a problem in sample delivery, we will credit the patient for a second test.