ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 10 challenged claims of Exact Sciences' U.S. Patent No. 11,970,746 (the '746 patent) unpatentable. This decision follows the PTAB's July 2025 Final Written. ...

Core Insights - Castle Biosciences significantly outperformed Wall Street expectations in Q2 2025, reporting GAAP EPS of $0.15 and non-GAAP revenue of $86.2 million, both exceeding analyst estimates [1][2] - The company raised its full-year 2025 revenue guidance to a range of $310 million to $320 million, reflecting stronger-than-expected adoption of key tests [10] Financial Performance - GAAP revenue for Q2 2025 was $86.2 million, nearly flat compared to $87.0 million in Q2 2024, with a year-over-year change of -0.9% [2] - Non-GAAP EPS was $0.16, down 51.6% from $0.31 in Q2 2024 [2] - Adjusted EBITDA fell to $10.4 million, a decrease of 51.6% compared to $21.5 million in Q2 2024 [2] - Gross margin decreased from 80.7% in Q2 2024 to 77.3% in Q2 2025, reflecting rising expenses and a less favorable sales mix [2][9] Business Overview - Castle Biosciences specializes in molecular diagnostics, focusing on tests that provide actionable information for managing skin, gastrointestinal, and mental health diseases [3] - The company aims to expand its test portfolio through launches and acquisitions while ensuring reimbursement coverage to support test adoption [4] Recent Developments - Total test volumes reached 26,574 in Q2 2025, a 6% increase year-over-year, primarily driven by core offerings like DecisionDx-Melanoma and TissueCypher [5] - DecisionDx-Melanoma received FDA's Breakthrough Device designation in Q2 2025, indicating regulatory recognition for its innovation [5] - TissueCypher test report volume increased by 117% year-over-year in Q1 2025, attributed to expanded sales force coverage and rising clinical demand [6] - The company discontinued the IDgenetix test due to reimbursement challenges, aiming to streamline operations and improve profitability [8] Strategic Focus - Management is refocusing commercial efforts towards melanoma tests following the loss of Medicare coverage for DecisionDx-SCC, which has significantly impacted revenue [7] - The acquisition of Previse aims to broaden the gastrointestinal segment's potential, although it is not expected to contribute meaningfully to 2025 financial results [6]

Core Viewpoint - OraSure Technologies, Inc. has authorized a stock repurchase program of up to $40 million over the next twenty-four months, to be funded from cash on hand [1][2]. Company Overview - OraSure Technologies, Inc. is a leader in point-of-need and home diagnostic tests and sample management solutions, aiming to improve access, quality, and value of healthcare through innovative testing and sample management [3]. - The company, along with its subsidiaries DNA Genotek Inc. and Sherlock Biosciences, Inc., develops, manufactures, and distributes rapid diagnostic tests and sample collection devices globally [3]. Stock Repurchase Program - The stock repurchase may be executed through various methods in compliance with applicable laws, with the timing and amount determined at the management's discretion [2]. - The repurchase program can be modified, suspended, or discontinued at any time without prior notice [2].