BETHLEHEM, Pa.- Medical technology company OraSure has secured the go-ahead from the federal government for a new product that the company has called key to its future growth.<\/p>\n
The Colli-Pee kit has secured clearance from the U.S. Food and Drug Administration (FDA), OraSure announced.\u00a0<\/p>\n
The kit, made by OraSure subsidiary DNA Genotek, is an at-home urine collection device. The FDA has cleared its use with\u00a0molecular diagnostic systems from the company Roche to identify a number of sexually transmitted infections (STIs).<\/p>\n
\u201cThis clearance connects people to care that is more accessible, convenient, private, and personalized. It showcases what\u2019s possible when you design solutions around real-life patient behavior,\u201d said Carrie Eglinton Manner, President and CEO of OraSure, in a news release.\u00a0<\/p>\n
Colli-Pee is one of two products for which OraSure submitted applications to the FDA at the end of 2025. The other is a rapid molecular self-test for the types of bacteria that cause the STIs Chlamydia and gonorrhoeae.\u00a0That test is made by Sherlock Bioscienses, another subsidiary of OraSure.<\/p>\n
OraSure, based in Bethlehem, has cited both devices as essential to the company’s return to growth in a post-COVID world. The company’s stock (NASDAQ: OSUR) has struggled in recent years, with shares dropping more than 57% since 2021.\u00a0<\/p>\n
But shares have shown some renewed vigor over the past month, after hovering near $3.00 or below since January of 2025. Shares were up more than 2% to $4.14 in early trading Thursday.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"BETHLEHEM, Pa.- Medical technology company OraSure has secured the go-ahead from the federal government for a new product…\n","protected":false},"author":2,"featured_media":217079,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[119,121,120,17458,51543],"class_list":["post-217078","post","type-post","status-publish","format-standard","has-post-thumbnail","category-allentown","tag-allentown","tag-allentown-headlines","tag-allentown-news","tag-food-and-drug-administration","tag-orasure-technologies"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/217078","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/comments?post=217078"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/posts\/217078\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media\/217079"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/media?parent=217078"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/categories?post=217078"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-pa\/wp-json\/wp\/v2\/tags?post=217078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}