NEW YORK – QuidelOrtho announced after the close of the market on Tuesday that it will discontinue development of its Savanna molecular diagnostic system and that it aims to acquire UK-based Lex Diagnostics for approximately $100 million.

纽约——奎德尔奥索公司周二在市场收盘后宣布，将停止开发其萨凡纳分子诊断系统，并计划以约1亿美元收购英国的莱克斯诊断公司。

'Our intended acquisition of Lex Diagnostics will strengthen and accelerate our presence in point-of-care molecular diagnostics — one of the largest and fastest-growing segments in the diagnostics industry,' said Brian Blaser, QuidelOrtho's president and CEO.

“我们计划收购Lex Diagnostics将加强并加速我们在即时医疗分子诊断领域的地位，这是诊断行业中规模最大、增长最快的细分市场之一，”奎德尔奥索公司总裁兼首席执行官布莱恩·布莱瑟表示。

On a call with investors, QuidelOrtho executives said the firm initially invested $20 million in Lex Diagnostics in December, 2023, followed by a $10 million investment in 2024. The initial investment included the exclusive option to acquire Lex Diagnostics up to or shortly after the 510(k) clearance of its point-of-care molecular test system by the US Food and Drug Administration.

在与投资者的电话会议上，QuidelOrtho 高管表示，该公司最初于 2023 年 12 月向 Lex Diagnostics 投资了 2000 万美元，随后在 2024 年又投资了 1000 万美元。初步投资包括在 Lex Diagnostics 的床旁分子检测系统获得美国食品药品监督管理局 (FDA) 的 510(k) 许可之前或之后，独家选择收购该公司的权利。

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The Lex Diagnostics system performs true PCR, with positive results in approximately six minutes and negative results in 10 minutes, which QuidelOrtho said can 'bring the sensitivity of PCR to urgent care centers, physician office labs, hospitals and other decentralized settings at a competitive price.'.

Lex Diagnostics系统执行真正的PCR，阳性结果大约在六分钟内得出，阴性结果则在十分钟内得出，QuidelOrtho表示这可以“以具有竞争力的价格将PCR的灵敏度带到急诊中心、医生办公室实验室、医院和其他分散的场所”。

Lex Diagnostics expects to submit dual 510(k) and CLIA-waiver applications to the FDA in the near future, QuidelOrtho said, and expects to receive 510(k) clearance in late 2025 or early 2026, depending on FDA review timelines. Lex Diagnostics is also submitting a multiplex test for the detection and differentiation of influenza A, influenza B, and COVID-19..

莱克斯诊断公司预计将很快向美国食品药品监督管理局（FDA）提交双重510(k) 和 CLIA豁免申请，快德尔奥索公司表示，并预计在2025年底或2026年初获得510(k)批准，具体取决于FDA的审查时间表。莱克斯诊断公司还正在提交一种多重检测方法，用于检测和区分甲型流感、乙型流感和新冠病毒。

QuidelOrtho first announced that it was developing the Savanna system in 2010. The firm ultimately obtained 501(k)

QuidelOrtho最早在2010年宣布正在开发Savanna系统。该公司最终获得了501(k)许可。

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in January 2024 for the instrument and an assay to detect and distinguish herpes simplex viruses. The firm then parted ways with its long-time CEO, Doug Bryant,  the following month, and soon announced it would be reviewing the Savanna project and withdrew its FDA submission for a four-plex respiratory test in April..

2024年1月，该仪器和检测两种单纯疱疹病毒的分析方法获得了FDA的批准。随后，该公司于次月与其长期首席执行官道格·布莱恩特分道扬镳，并很快宣布将对萨凡纳项目进行审查，且于4月撤回了其四重呼吸道测试的FDA申请。

In its statement, QuidelOrtho said the decision to discontinue Savanna was in part related to recent results of its clinical trial for the retooled respiratory assay. 'In comparing the results of recent clinical trial data, investment requirements, and the significant market opportunity for both the Savanna and Lex Diagnostics platforms, we determined that Lex Diagnostics offers important performance advantages for customers and is better aligned with our strengths and opportunities for growth,' Blaser said in the statement..

在其声明中，QuidelOrtho 表示，决定停止 Savanna 平台的部分原因与最近对其改进后的呼吸道检测临床试验结果有关。“在比较最近的临床试验数据、投资需求以及 Savanna 和 Lex Diagnostics 平台的巨大市场机会后，我们认为 Lex Diagnostics 能为客户提供重要的性能优势，并且更符合我们的优势和增长机会，”布拉泽在声明中说道。

QuidelOrtho will now work closely with customers who acquired the Savanna herpes panel to establish a transition plan.

QuidelOrtho 将与购买了 Savanna 疱疹面板的客户密切合作，制定过渡计划。

The firm also said that it is maintaining its full year 2025 guidance of

该公司还表示，维持其对 2025 年全年的指导方针不变。

$2.60 billion to $2.81 billion in total revenues, with adjusted EPS expected to be in the range of $2.07 to $2.57.

总收入为 26 亿美元至 28.1 亿美元，调整后每股收益预计在 2.07 美元至 2.57 美元之间。