This article was originally published in The Gray Sheet
Cancer screening test firm CytoCore receives 510(k) clearance for its SoftPap cervical cell collector Jan. 30 and plans to sign its first U.S. distribution agreements in the coming days for launch by the end of March, the firm said Feb. 5. SoftPap consists of a reusable handle and disposable balloon, which inflates inside the body to collect cervical cells. CytoCore says the system collects better samples than the alternative spatula and brush collection method, and could be used with Cytyc/Hologic's ThinPrep liquid-based Pap test and BD/TriPath's SurePath test. The device will cost $10-$12 out-of-pocket, compared to less than $1 for the reimbursed brush technique, but will "more than prove to be cost-effective," marketing director Dan McMahon claims. SoftPap has been sold in Europe since late December
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