Is your product FDA approved?
Not yet. We have contacted the FDA and the data we are collecting will be used to file for approval. Our kit is however very safe as it is entirely made of commercially available products.
Is Exogen’s database project approved by an IRB?
An Institutional Review Board (IRB) is a federally mandated panel that is charged with overseeing the protection of human participants in research. Exogen has submitted to a third party IRB all documentation describing the assay’s protocol, the consent form users need to read and sign and the questionnaire used to correlate DNA damage to various important lifestyle parameters. The IRB found that Exogen had put in place a process that protected our users and approved the study. More specifically:
i. participants’ rights and welfare are adequately protected,
ii. research is guided by the ethical principles of respect for persons, beneficence, and justice as set forth in the Belmont Report,
iii. research is conducted with the highest level of expertise and integrity, and
iv. research complies with all applicable laws, policies and regulations.
Are the components in your kit safe to touch?
The fixative in the collection tubes provided in our kits contains formaldehyde in concentration comparable that what is found in cosmetics, and as such should not be tampered with, taken out, dispersed on your skin, ingested or inhaled. If some fixative spills on your skin, wash it for 10 min in cold water. If you ingested the fixative, immediately contact a poison center.
How long can I keep my kit in the fridge?
The fixative used is stable at 4 degrees C for two weeks. Keep it in the dark until usage. Once blood is collected, keep it in the fridge and ship it back to us as soon as possible but no later than three days post-collection.
I have messed up collection and I ran out of mini-capillaries or disposable lancets.
The basic kit allows you to do three measurements, but you are provided extra samples in case of manipulation error. Your basic kit should come with five disposable lancets (2 extra), four mini-capillary (1 extra) and four collection tubes. If you handle your kit correctly, you will be able to ship back four samples and Exogen will be happy to process the extra one at no cost as long as you registered it. If you request extra items in case of depletion of the kit’s components, Exogen will charge a full new kit and will ship it to you.
How long does it take to get my results?
If you live in the United States, expect four days from shipping to delivery. Sample analysis can take one to two weeks, depending on the amount of samples we receive. We are working hard at reducing this delay and hope to provide results in the future within one week. Once processed, you will receive an email to prompt you to log onto our web page/app to get your results.
I want to learn more about what you do and give you feedback, what is the best way to contact you?
Emails are always welcome and your feedback is critical to improve our kit, our web page/app and the type of information you want to have. We are also planning to have regular webinars to discuss our most recent results and updates regarding Exogen. You will be able to register to these events on our web page.
How reproducible are these measurements?
There are many factors that can affect the accuracy of the number we measure and we put in place a protocol to reduce error. Before you collect your sample, record your diet and activity using our online questionnaire.Make sure you follow the protocol for collection and preservation of specimen.
We now report our analysis based on a specific lineage of lymphocytes. By reducing our measurements to specific cell types, we have achieved 8% relative error. We advise triplicate measurements for baseline level (basic kit), taken early in the morning before eating to avoid diet effect. If all three measurements on three consecutive days are not within the expected relative error, we will let you know and help you resolve the potential source of the variability.
Are my personal genetic data of interest to you?
Absolutely. We are very keen on linking DNA repair gene deficiencies to your DNA damage baseline. Exogen has the software and the expertise to import such data. We are planning to create a simple application allowing you to upload your genetic data.
Which marker of DNA damage are you using… is it presence of gamma2x foci?
We are looking at P53 Binding protein 1 (53BP1). We have published on this marker extensively (Plos Comp Bio 2007, PNAS 2012) and shown it is a more reliable DNA Damage marker than gamma-H2AX as it is less prone to change with cell cycle.