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OMNIgene. GUT Dx is intended for the non-invasive collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene GUT Dx.

The OMNIgene . GUT Dx device consists of a collection tube with a tube top and pusher cap with a screw seal, along with a spatula or spoon for transferring fecal specimen into the collection tube. The tube contains 2 mL of the stabilizing liquid and a stainless-steel mixing ball. These components are intended to stabilize bacterial DNA in human fecal specimens. notably to preserve the relative abundances of bacterial organisms, for potential downstream analysis of the fecal microbiome. The collection device is designed for storage of fecal specimens at room temperature (20-26°C/68-79°F) for up to 30 days.

Oragene®•Dx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. Saliva may be collected by spitting directly into the Oragene®•Dx container or may be transferred into the Oragene® Dx container using a sponge. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using Oragene®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using Oragene®•Dx can be transported and/or stored long term at ambient conditions

Oragene®●Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. Oragene®●Dx devices are a noninvasive alternative for collecting high quality and quantity DNA for use with prescription and over-thecounter (direct-to-consumer) diagnostic testing applications. Oragene®●Dx devices consist of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube or may be transferred into the Oragene®●Dx container using a sponge. Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field. Untrained (naïve) or professional users can carry out saliva collection. After saliva is collected, the stabilizing liquid is mixed with the sample. A small cap is provided to close the tube for transport and storage (funnel with lid is removed and discarded). Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). Samples can be immediately processed, transported or stored for future use. Samples can be shipped at ambient temperature to the laboratory for processing. Oragene® •Dx samples are stable at room temperature for up to 12 months. Device and sample integrity are preserved during typical ambient transport and storage conditions. Oragene®●Dx saliva collection devices are suitable for use with prescription and over-the-counter (direct-to-consumer) downstream diagnostic testing applications, systems or platforms. Test or assay manufacturers must validate the use of Oragene®●Dx for their specific indications for use. Using DNA obtained from an Oragene®●Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory. The resulting genetic information may be used to generate a personalized health report related to detected mutations and may be used by medical and health practitioners as an aid in patient management.

ORAcollect Dx is intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva sample sultured using ORAcollect+Dx are stabilized and can be transported and/or stored long term at anbient can adions.

The ORAcollect-Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. ORAcollect-Dx is a non-invasive alternative for collecting high quality and quantity human DNA and is suitable for use in molecular diagnostic applications. ORAcollect-Dx consists of a collection tube containing a stabilizing liquid and a double ended cap with an integrated sponge used to collect a saliva sample. After receiving instruction from a professional, saliva collection can take place in a laboratory setting, physician's office, at home, or in the field. Untrained (naïve) or professional users can carry out saliva collection. Using the provided instructions for use, the integrated sponge on the device to collect a saliva sample from the mouth. After saliva is collected, the cap is removed from the tube, inverted to place the sponge into the collection tube with the stabilizing liquid, and re-capped with the sponge remaining inside the tube. Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). Samples can be immediately processed, transported or stored for future use. Samples can be shipped at ambient temperature to the laboratory for processing. ORAcollect-Dx device pre-collection shelf life is 24 months at room temperature (15°C to 25°C) from the date of manufacture. Post collection, ORAcollect·Dx samples are stable at room temperature for up to 60 days. ORAcollect · Dx device and sample integrity are preserved during typical ambient transport and storage conditions.