NEW YORK – Last year, a 15-year research and development slog finally culminated in regulatory approval and instrument sales for QuidelOrtho's Savanna molecular diagnostics system.

纽约——去年，长达15年的研发工作终于迎来了QuidelOrtho的Savanna分子诊断系统获得监管批准并实现仪器销售。

But in a twist highlighting how fortunes can dramatically change in the diagnostics space, just 18 months later, the company

然而，这一转变凸显了诊断领域内的财富如何能发生戏剧性的变化，仅仅18个月后，这家公司

announced

宣布

on Tuesday it is abandoning Savanna in favor of acquiring UK startup Lex Diagnostics and its faster, cheaper, easier to use platform for up to $100 million.

周二，该公司放弃了萨凡纳，转而收购英国初创公司Lex Diagnostics及其更快、更便宜、更易使用的平台，交易金额高达1亿美元。

On a call to discuss the pivot, executives at the San Diego-based firm pointed to trends in the diagnostics market to justify its change of heart.

在一次讨论转型的电话会议上，这家位于圣地亚哥的公司的高管们指出了诊断市场趋势，以此为其改变初衷提供理由。

QuidelOrtho, then called Quidel, first described Savanna in 2010, when the project was called Operation Wildcat. With core technology initially developed in a

2010年，当时名为奎德尔的奎德尔奥索公司首次描述了萨凡纳，当时该项目被称为“野猫行动”。核心技术最初开发于一个

collaboration

协作

with researchers at Northwestern University's Global Health Foundation, and a total

与西北大学全球健康基金会的研究人员，以及总计

commitment

承诺

of approximately $21 million from the Bill and Melinda Gates Foundation, Savanna was initially positioned as a rapid molecular tool that could be deployed at the point of care as well as in low-resource settings.

大约 2100 万美元来自比尔和梅琳达·盖茨基金会，Savanna 最初被定位为一种快速分子工具，可以在护理点以及资源匮乏的环境中部署。

Savanna became the keystone of QuidelOrtho's long-term growth strategies in decentralized molecular diagnostics, intended to diversify the portfolio and decrease the firm's reliance on seasonal and fluctuating rapid influenza test sales.

萨瓦纳成为了奎德尔奥索公司在分散式分子诊断领域长期增长战略的基石，旨在实现产品组合的多样化，并减少公司对季节性和波动性的快速流感测试销售的依赖。

QuidelOrtho

快德奥索

debuted

首次亮相

a prototype of the platform at the American Association for Clinical Chemistry conference in 2014 that was roughly the size of a desktop computer. But soon, the firm set about making changes — reducing the instrument to toaster-sized, increasing the multiplexing capabilities, dropping the optional isothermal nucleic acid amplification in favor of a PCR-only approach, and shuffling the test menu pipeline — causing project delays.

2014年美国临床化学协会会议上展出的平台原型，该设备大约是一台台式计算机的大小。但很快，公司就开始做出改变——将仪器缩小到烤面包机大小，提高多重分析能力，放弃可选的等温核酸扩增而采用仅PCR的方法，并重新调整测试菜单的优先顺序——导致项目延期。

.

。

Finally, in February 2024 — two months after the Savanna system was granted 510(k)

最后，在2024年2月——即Savanna系统获得510(k)许可的两个月后

clearance

清仓

from the US Food and Drug Administration along with a panel to detect and differentiate different herpes simplex viruses — the firm submitted its respiratory panel originally intended to be its first assay. Then on Valentine's Day, a guidance

来自美国食品药品监督管理局的指导，以及一个用于检测和区分不同单纯疱疹病毒的小组——该公司最初提交了其呼吸道面板，原本计划作为其首个检测方法。然后在情人节当天，一份指导文件

miss

错过

led QuidelOrtho to

导致QuidelOrtho公司

part ways

分道扬镳

with CEO Douglas Bryant, who had been with the company since 2009.

与自2009年以来一直在公司的首席执行官道格拉斯·布莱恩特一起。

A triumvirate of execs temporarily helmed the firm, and in March 2024 they

2024年3月，三位高管组成的三驾马车暂时掌管了公司，

affirmed

确认

QuidelOrtho's prior 2024 revenue expectations for Savanna, noting that clearance of the respiratory panel, dubbed RVP4, would catalyze its placement.

QuidelOrtho公司对Savanna在2024年的收入预期，指出呼吸道检测面板（被称为RVP4）的批准将推动其布局。

However, in April 2024 the firm

然而，在2024年4月，该公司

withdrew

撤回

its FDA submission for the respiratory panel, stating that it ultimately did not meet its high standards.

其呼吸道面板的FDA提交，称其最终未达到其高标准。

A month later, the firm's new CEO, Brian Blaser, said he would thoroughly review the Savanna project. At the JP Morgan Healthcare Conference this past January he said Savanna represented the molecular diagnostics business' largest near-term opportunity for growth, and on a call to discuss QuidelOrtho's first quarter 2025 financial results last month, he said the respiratory panel was in the final stages of its clinical trial.

一个月后，该公司新任首席执行官布莱恩·布拉泽表示，他将全面审查萨凡纳项目。在今年一月的摩根大通医疗保健会议上，他表示萨凡纳代表了分子诊断业务近期增长的最大机会。在上个月讨论奎德尔奥思2025年第一季度财务业绩的电话会议上，他提到呼吸道检测面板正处于临床试验的最后阶段。

.

。

However, QuidelOrtho disclosed on Tuesday that it had been eyeing an out from Savanna in the potential acquisition of Lex Diagnostics for at least the past 18 months, beginning under Bryant's leadership.

然而，奎德尔奥索公司周二披露，在布莱恩特的领导下，该公司至少在过去18个月里一直在考虑摆脱萨凡纳，作为潜在收购Lex诊断公司的一部分。

On Tuesday's call, the firm's CFO Joe Busky said QuidelOrtho made an initial $20 million investment in Cambridge, England-based Lex Diagnostics in December of 2023 — around the time that the FDA gave its stamp of approval to Savanna — with a subsequent investment of $10 million in 2024.

在周二的电话会议上，该公司首席财务官乔·布斯基因表示，奎德尔奥索公司在2023年12月对位于英国剑桥的Lex Diagnostics公司进行了初步2000万美元的投资——大约在FDA批准Savanna的同时——并在2024年追加了1000万美元的投资。

An agreement between the two firms at the time also gave QuidelOrtho dibs on acquiring Lex Diagnostics on or before the date its platform was granted FDA clearance. This was subsequent to a deal made in 2021 when GenMark Diagnostics, now part of Roche, invested in Lex Diagnostics as part of a definite option agreement, a representative of Lex Diagnostics .

两家公司当时达成的协议还让奎德尔奥索公司在其平台获得FDA批准的当日或之前拥有收购Lex Diagnostics的优先权。这随后促成了2021年的一笔交易，当时罗氏旗下的GenMark Diagnostics作为确定选择权协议的一部分投资了Lex Diagnostics。

told

告诉

GenomeWeb

基因组网

in 2022.

2022年。

Busky said the investments were structured as a convertible loan. The approximately $100 million acquisition price will be paid at closing, which the firm expects to occur in early 2026, funded using a combination of cash and its revolving line of credit.

布斯基表示，这些投资被设计为可转换贷款。约1亿美元的收购价格将在交易结束时支付，公司预计这将发生在2026年初，资金来源将是现金和其循环信贷额度的组合。

'We may also pay up to $40 million in additional purchase price based on an earn-out component, payable for up to six years following the closing of the acquisition,' Busky added.

“我们还可能根据收益分成条款支付高达4000万美元的额外购买价格，这笔款项将在收购完成后的六年内支付，”布斯基补充道。

Finally, the firm expects a $130 million to $150 million write-off related to manufacturing equipment and inventory for Savanna, and approximately $25 million in annualized benefit from stopping the project.

最终，该公司预计将冲销1.3亿至1.5亿美元与Savanna相关的制造设备和库存，并预计从停止该项目中获得约2500万美元的年度收益。

Tamara Ranalli, the firm's senior VP of point-of-care and molecular diagnostics who has been with QuidelOrtho for more than 16 years, said during the call that the market has evolved since Savanna was originally proposed.

塔玛拉·拉纳利（Tamara Ranalli）是公司床旁检测和分子诊断业务的高级副总裁，她已经在奎德尔奥索（QuidelOrtho）工作了16年以上，在电话会议中表示，自从萨凡纳（Savanna）最初被提出以来，市场已经发生了变化。

QuidelOrtho originally targeted the centralized hospital testing space for Savanna, Ranalli said, as these customers seek moderately fast, broadly syndromic panels as an alternative to core laboratory molecular testing, and the space is growing at a mid- to high-single digit rate. But the decentralized testing space, which includes emergency departments, clinics, and physician offices, is expanding at a double-digit rate 'as demand for faster near patient testing has continued to accelerate,' she said.

兰纳利表示，奎德尔奥索公司最初将萨凡纳的目标定在集中式医院检测领域，因为这些客户寻求中等速度、广泛适用的综合检测板，作为核心实验室分子检测的替代方案，而且这一领域正以中高个位数增长率扩大。但是，包括急诊科、诊所和医生办公室在内的分散式检测领域正以两位数的速度增长，“因为对更快速的近患者检测的需求持续加速”。

.

。

This ongoing shift toward more decentralized molecular testing was a primary motivation for the pivot. However, Ranalli also said that bringing Savanna's larger, more complex panels to commercialization would likely require longer and more expensive development cycles compared to tests on the Lex Diagnostics system.

这种向更加分散的分子检测的持续转变是此次转型的主要动机。然而，Ranalli还表示，与Lex Diagnostics系统上的测试相比，将Savanna更大、更复杂的检测面板商业化可能需要更长且更昂贵的开发周期。

.

。

The six-minute turnaround time for true PCR results on the Lex platform is ideal for the decentralized setting, Ranalli said, and the direct-from-swab workflow may also be an enticement for customers.

兰纳利说，Lex 平台上真正的 PCR 检测结果六分钟内即可出炉，非常适合分散式环境，而直接从拭子开始的工作流程也可能吸引客户。

Furthermore, 'While there are some other competitive molecular platforms out there in this space, none have offered the combination of multiplex testing in under 10 minutes with a workflow as simple as the Lex platform,' Ranalli added.

此外，拉纳利补充说：“虽然在这个领域还有其他一些具有竞争力的分子平台，但没有任何一个平台能像Lex平台那样，在不到10分钟的时间内提供多重测试，并且工作流程如此简单。”

Busky said the firm would maintain its full year 2025 guidance — $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 — but expected to see an $11 million benefit this year from dropping Savanna. Rather than up the guidance, he said the firm would maintain the current guidance as a buffer against tariff uncertainties..

布斯基表示，该公司将维持其 2025 全年的指导方针——总收入在 26 亿美元至 28.1 亿美元之间，调整后的每股收益预计在 2.07 美元至 2.57 美元之间——但预计今年将从放弃萨凡纳（Savanna）中获得 1100 万美元的收益。他称，公司不会提高指导方针，而是会保持当前的指导方针，以作为应对关税不确定性的缓冲。

UBS analyst Lu Li said in a note to investors that she was surprised by disappointing results from Savanna after multiple delays in the past but believes the Lex Diagnostics pivot to be 'a logical option' that allows QuidelOrtho to stay in the point-of-care molecular diagnostics race.

瑞银分析师李璐在一份给投资者的报告中表示，她对萨凡纳在经历了多次延误后的令人失望的结果感到惊讶，但她认为莱克斯诊断的转型是一个“合乎逻辑的选择”，可以让奎德尔奥索继续留在即时医疗分子诊断的竞争中。

'We don't think the strategy shift is thesis changing given the competitive molecular point-of-care market,' she added.

“鉴于竞争激烈的分子即时检测市场，我们认为这一战略转变并不会改变我们的核心观点，”她补充道。

Tycho Peterson at JP Morgan, meanwhile, said in his note to investors that from the start, 'we have been skeptical on Savanna and its ability to disrupt the molecular diagnostics market, given the checkered past of delays and a highly-competitive landscape.'

与此同时，摩根大通的泰科·彼得森在给投资者的报告中表示，从一开始，“鉴于萨凡纳过往的延迟记录以及竞争激烈的市场环境，我们对其能否颠覆分子诊断市场持怀疑态度。”

That said, 'for however low we viewed the probability of Savanna becoming a successful disruptor, it did at least provide [QuidelOrtho] with hopes of having an attractive secular growth story,' he added. Replacing Savanna with the Lex system is a positive, he also said, but noted that the plan is not totally de-risked as the system has yet to be approved by the FDA..

他说：“尽管我们认为萨凡纳成为成功颠覆者的概率很低，但它至少为[奎德尔奥索]提供了一个有吸引力的长期增长故事的希望。” 他补充说，用Lex系统取代萨凡纳是一个积极的进展，但他指出，该计划并非完全没有风险，因为该系统尚未获得FDA的批准。

Savanna v Lex

热带稀树草原 v Lex

In its 2024 annual report, QuidelOrtho described Savanna as a CE-marked, 510(k) approved, multiplex, real-time PCR platform. It sported customizable syndromic panels that could detect up to 12 analytes from a single patient sample in less than 25 minutes.

在2024年年度报告中，QuidelOrtho 将Savanna描述为一种CE认证、510(k)批准的多重实时PCR平台。该平台配备了可定制的综合征面板，能够在不到25分钟内从单个患者样本中检测多达12种分析物。

The Savanna RVP4 assay offered simultaneous detection and differentiation of influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2 from nasal or nasopharyngeal swabs. The firm was also developing a novel function for Savanna dubbed Test Select, which would enable end users to mask results for targets that clinicians did not wish to order.

Savanna RVP4 检测试剂盒能够同时检测和区分甲型流感、乙型流感、呼吸道合胞病毒和 SARS-CoV-2，样本来源于鼻拭子或鼻咽拭子。该公司还在为 Savanna 开发一项名为“Test Select”的新功能，该功能将允许最终用户屏蔽临床医生未要求检测的目标结果。

.

。

Meanwhile, Lex Diagnostics spun off from UK technology development firm TTP Group with a sample-to-answer point-of-care infectious disease diagnostic system using ultra-fast PCR and thin, flat reaction chambers that are inexpensive to manufacture. The system accepts swab samples directly, obviating the need for liquid handling, and the turnaround time for positive tests is six minutes with negative results taking up to 10 minutes.

同时，Lex Diagnostics从英国技术开发公司TTP集团分拆出来，推出了一种样本到结果的即时护理传染病诊断系统，该系统采用超快速PCR和薄型平板反应室，制造成本低廉。该系统直接接受拭子样本，无需液体处理，阳性测试的结果周转时间为六分钟，而阴性结果最多需要十分钟。

.

。

Both systems use PCR rather than isothermal chemistries, and while the Lex system produces results 15 minutes faster, Savanna was able to perform higher multiplexing.

两个系统都使用PCR而不是等温化学技术，虽然Lex系统产生结果快15分钟，但Savanna能够实现更高的多重检测。

QuidelOrtho did extensive due diligence to be sure the Lex Diagnostics system was the best option going forward, Ranalli said on the call, comparing it to Savanna as well as to other systems that could potentially be acquired in the diagnostics space.

拉纳利在电话中表示，奎德尔奥索进行了广泛的尽职调查，以确保Lex诊断系统是前进的最佳选择，并将其与萨凡纳以及其他可能在诊断领域收购的系统进行了比较。

But QuidelOrtho Chief Technology Officer Jonathan Siegrist said during the call that the RVP4 test encountered performance issues specifically with the respiratory syncytial virus target, partly related to the prevalence of RSV during the trial period.

但奎德尔奥索首席技术官乔纳森·西格里斯特在电话中表示，RVP4测试在呼吸道合胞病毒目标上遇到了性能问题，部分原因与试验期间RSV的流行有关。

'As a result, we were left with a flu A, flu B, and COVID three-plex Savannah assay, as the RSV sensitivity just didn't meet our high performance standards,' he said.

“因此，我们最终采用了流感A、流感B和COVID三重Savannah检测方法，因为RSV的灵敏度确实没有达到我们的高性能标准，”他说道。

Siegrist, who joined QuidelOrtho in October 2024 after more than 13 years with Cepheid, noted that in parallel with the Savanna RVP4 clinical trial the firm was performing the extensive evaluations of the Lex platform.

西格里斯特于2024年10月加入奎德尔奥尔托公司，此前他在赛沛公司工作了13年以上。他指出，与萨凡纳RVP4临床试验同步，该公司正在对Lex平台进行广泛评估。

'We were seeing impressive clinical performance, and this created a natural decision point for us,' he said.

“我们看到了令人印象深刻的临床表现，这为我们创造了一个自然的决策点，”他说道。

Although the Lex respiratory test doesn't have an RSV target — Siegrist said the platform can only multiplex three targets plus a control — QuidelOrtho sees the potential to expand the multiplexing ability somewhat for future tests. The Lex system also uses lyophilized reagents, as did Savanna, so that element of the manufacturing process will likely remain consistent..

尽管Lex呼吸系统测试没有RSV目标——西格里斯特表示该平台只能多重检测三个目标加一个对照——奎德尔奥森认为未来测试中有可能将多重检测能力提高一些。Lex系统还使用了冻干试剂，萨凡纳也是如此，因此这部分制造过程可能会保持一致。

Overall, Blaser called the cost structure at volume for the Lex system 'very attractive,' noting that the margin profile will allow QuidelOrtho to 'very competitively price the product versus others that are on the market today.'

总体而言，布拉泽称Lex系统的成本结构在产量方面“非常有吸引力”，并指出利润率将使QuidelOrtho能够“相对于目前市场上的其他产品非常有竞争力地定价。”

POC landscape

概念验证 (POC) 环境

QuidelOrtho's shift in its point-of-care testing strategy comes against a backdrop of unfulfilled expectations in the overall POC molecular testing landscape. When the first POC molecular system received CLIA waiver in 2015, some

QuidelOrtho在即时检测战略上的转变，正值整个POC分子检测领域未能实现预期的背景下。当首个POC分子系统在2015年获得CLIA豁免时，一些人...

predicted

预测

a sharp uptake in such systems. That largely has not happened.

此类系统的急剧普及。但这种情况在很大程度上并未发生。

The point-of-care molecular testing market was inaugurated in 2015 with the clearance and CLIA waiver of the Abbott ID Now isothermal platform, followed by the Roche Cobas Liat and the Cepheid GeneXpert Xpress PCR systems. Cepheid also disclosed in 2015 that it was developing a true point-of-care instrument called the Omni, although it ultimately abandoned the project approximately seven years later..

2015年，随着雅培ID Now等温平台的获批和CLIA豁免，床旁分子检测市场正式启动，随后是罗氏Cobas Liat和Cepheid GeneXpert Xpress PCR系统。Cepheid还在2015年透露，正在开发一款名为Omni的真正床旁检测仪器，但最终在大约七年后放弃了该项目。

When the value of rapid diagnostic testing finally broke through in the popular consciousness during the COVID-19 pandemic, it also seemed that a shift from immunoassays to molecular tests was imminent. Uptake of legacy systems has not dramatically impacted those firms' bottom lines, however, and while a number of new rapid molecular systems from startups saw sales after being cleared by the FDA, some of the manufacturers did not survive the post-COVID bust.  .

在新冠疫情期间，快速诊断测试的价值终于在大众意识中得到突破，似乎从免疫测定向分子检测的转变也即将到来。然而，传统系统的应用并没有显著影响这些公司的利润，尽管一些获得FDA批准的初创公司推出的新型快速分子系统实现了销售，但其中一些制造商未能在疫情后的萧条中生存下来。

During the call, the QuidelOrtho team maintained that point-of-care molecular is still one of the most attractive and fastest growing markets in the

在电话会议中，QuidelOrtho 团队坚称，床旁分子诊断仍然是最具吸引力且增长最快的市场之一。

in vitro

体外

diagnostics space. Ranalli also observed that customers are seeking to incorporate both immunoassays and molecular tests in their point of care workflows, so these products are unlikely to compete with each other and being able to provide both could be an advantage.

诊断领域。Ranalli还观察到，客户希望在其即时护理工作流程中同时纳入免疫测定和分子测试，因此这些产品不太可能相互竞争，能够同时提供这两者可能是一个优势。

In addition to the Roche, Abbot, and Cepheid platforms, the rapid molecular point-of-care test space currently includes at least one particularly imposing new competitor — the BioMérieux BioFire SpotFire. Since SpotFire's commercial launch in 2023, the firm has obtained regulatory clearance for four panels and reported dramatic sales growth for the PCR system that can detect up to 15 targets in 15 minutes.

除了罗氏、雅培和Cepheid平台外，快速分子即时检测领域目前至少迎来了一位特别强大的新竞争者——生物梅里埃的BioFire SpotFire。自SpotFire于2023年商业化推出以来，该公司已获得四项检测面板的监管批准，并报告了这款能在15分钟内检测多达15个靶标的PCR系统的销售大幅增长。

And of course FDA-cleared true PCR systems from smaller firms like Visby or Nuclein are also potential competitors as well..

当然，像Visby或Nuclein这样的小型公司所推出的经FDA认证的真正PCR系统也同样具有潜在竞争力。

In the end, Blaser said that although abandoning Savanna was not an easy decision, 'We made it with deep appreciation for the tremendous effort that has gone into developing the system over the last several years.'

最终，布拉泽表示，虽然放弃萨凡纳这个决定并不轻松，但“我们深深感激过去几年来开发该系统所付出的巨大努力。”

And going forward, assuming the Lex Diagnostics system clears the FDA and its acquisition by QuidelOrtho is realized, the firm plans to expand the menu to include RSV, Group A Strep, women's health, and other assays.

展望未来，假设Lex Diagnostics系统通过FDA审批，并且QuidelOrtho成功完成对其的收购，该公司计划扩展产品菜单，包括RSV、A组链球菌、女性健康及其他检测项目。