Shineco granted US patent, FDA marketing approval for fecal specimen sampling device
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Shineco Inc. announced it has been granted a United States Patent and Trademark Office patent and FDA marketing approval for its in-situ fecal specimen sampling device intended for stool test sample collection..
The sampling device includes a massager-like fingertip swab, a collection tube and a lid with unidirectional sampling inlet that can be used for self-collection while defecation and doesn’t require a container or plastic bag for this process, according to a company release. Then, laboratory staff can complete the testing procedures without being required to open the sample tube.
“We are extremely pleased with the grant of a U.S. patent and the marketing approval from FDA for our easy-to-use disposable stool test sample collector, which gives us strong support to optimize the stool sample collection in clinical stool test,” Marvin Liu, MD, chairman of Shineco’s controlling affiliate, Changzhou Biowin Pharmaceutical Company, Ltd., said in the release.
Liu noted that although “the stool test is a very common clinical lab examination and requires the collection of stool sample from the patient,” the current method of sample collecting is inconvenient, requiring the passing of a stool specimen into a clean, dry container directly or by placing a plastic bag inside the toilet bowl.
“This easy-to-use disposable stool test sample collector provides a very simple, easy and complete privacy protected tool for stool sample collection,” Liu said in the release. “The collection procedure can be done while [defecating, either] squatting or sitting or can be done after defecation. This not only prevents samples from contamination, but also provides a sanitary measure for laboratory staff to work on the stool sample.”
Shineco recently presented its device at MEDICA 2022, an annual exhibition of medical devices, in Düsseldorf, Germany.