NEW YORK – Scout Health is aiming to expand the use of point-of-care molecular testing — perhaps even to consumers' homes — with a novel approach that enables sensitive and specific single-tube multiplexing of isothermal nucleic acid amplification.

纽约——Scout Health 旨在通过一种新颖的方法扩大即时分子检测的使用范围，甚至可能扩展到消费者的家中。这种方法能够实现等温核酸扩增的灵敏且特异的单管多重检测。

Last week, the startup showed off its multiplexing capabilities, ability to rapidly develop new assays, and assay usability in home settings at Cambridge Healthtech Institute's Precision Medicine Tri-Con conference in San Diego.

上周，这家初创公司在圣地亚哥剑桥健康技术研究所的精准医学三合一会会议上展示了其多路复用能力、快速开发新检测方法的能力以及在家庭环境中检测的可用性。

Scout initially used a $14.9 million award from the National Institutes of Health's Rapid Acceleration of Diagnostics (

Scout最初使用了来自美国国立卫生研究院快速诊断加速计划（Rapid Acceleration of Diagnostics）的1490万美元奖励。

RADx

快速诊断加速计划

) initiative to develop an assay to detect SARS-CoV-2. Under its former name of Uh-Oh Labs, the firm obtained

）倡议开发一种检测SARS-CoV-2的测试方法。在其前身为Uh-Oh Labs时，该公司获得了

Emergency Use Authorization

紧急使用授权

for its COVID test in 2022.

由于其在2022年的COVID测试。

More recently, Scout was

最近，Scout被

awarded

授予

$1 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to develop a low-cost, multiplex point-of-care molecular diagnostic test for the sexually transmitted infections

来自抗击抗生素耐药细菌生物制药加速器（CARB-X）的100万美元，用于开发一种低成本、多重分子即时检测性传播感染的诊断测试。

Neisseria gonorrhoeae

淋病奈瑟菌

and

和

Chlamydia trachomatis

沙眼衣原体

.

。

Isothermal nucleic amplification is typically more sensitive and specific than antigen testing yet less time-consuming and cheaper than PCR.

等温核酸扩增通常比抗原检测更敏感和特异，同时比PCR更省时且成本更低。

However, while they can attain the ideal point-of-care sweet spot of high accuracy and low cost, isothermal assays can be quite tricky to develop since they require six primers.

然而，虽然它们可以达到高准确性和低成本的理想即时检验点，但等温检测法的开发可能会相当棘手，因为它们需要六种引物。

Multiplexing isothermal amplification assays have also previously demanded fluorescent chemistries, as the reactions are inhibited by high concentrations of primers and colorimetric readouts would be too dim to see. This has in turn necessitated more complex fluorescence reader devices for multiplex isothermal tests..

多重等温扩增检测此前也要求使用荧光化学，因为反应会被高浓度引物抑制，且比色读数过于微弱而难以观察。这反过来又使得多重等温测试需要更复杂的荧光读取设备。

Cam Ball, cofounder and chief technology officer at Scout, said that the firm's patented solution — dubbed loop-de-loop — essentially eliminates the inhibition problem and increases the sensitivity of isothermal reactions, so they can be readily multiplexed using a less costly reader.

Scout公司的联合创始人兼首席技术官康·鲍尔表示，公司获得专利的解决方案（被称为 loop-de-loop）基本上消除了抑制问题并提高了等温反应的灵敏度，因此可以使用成本较低的读取器轻松实现多重分析。

'We have some reactions with up to 70 primers,' he said in an interview this week.

“我们有一些反应使用多达70个引物，”他在本周的采访中说道。

The loop-de-loop approach uses a looped primer attached to a quenched fluorophore, and it can insert itself into double-stranded DNA during a process known as

循环引物方法使用连接到淬灭荧光团的环状引物，并且在称为

DNA breathing

DNA呼吸

, according to a poster the firm presented at Tri-Con.

，根据该公司在Tri-Con上展示的海报。

Once incorporated into an amplicon, the reverse complement of the loop-de-loop primer is generated using a strand-displacing polymerase, which unquenches the fluorophore and yields a bright fluorescence.

一旦被整合到扩增子中，使用链置换聚合酶生成环状引物的反向互补序列，这会使荧光团去淬灭并产生明亮的荧光。

Loop-de-loop primers melt open and fluoresce at approximately 10 degrees above the reaction temperature and also when incorporated into amplification products, according to the poster.

根据海报，Loop-de-loop 引物在高于反应温度约 10 度时会熔解并发出荧光，当被整合到扩增产物中时也是如此。

The method is adaptable to any type of isothermal amplification assay, including but not limited to loop-mediated isothermal amplification, Ball said.

鲍尔表示，该方法可适用于任何类型的等温扩增检测，包括但不限于环介导等温扩增。

Alex Jiao, cofounder and CEO of Scout, said in an interview that the loop-de-loop chemistry enables the Santa Clara, California-based firm to do its test development on standard lab equipment with very straightforward design transfer to the Scout system.

焦亚历克斯（Alex Jiao），Scout公司的联合创始人兼首席执行官，在一次采访中表示，循环化学技术使得这家位于加利福尼亚州圣克拉拉的公司能够在标准实验室设备上进行测试开发，并将其设计直接转移到Scout系统中。

'We don't have to create like any complex consumables or cartridges, or do any verification or pilot production prototyping,' he said, which means assay development can be quite rapid.

“我们不需要创建任何复杂的消耗品或墨盒，也不需要进行任何验证或试生产原型设计，”他说，这意味着检测开发可以非常迅速。

Proof of concept

概念验证

Scout scientists also described several proof-of-concept studies in their poster.

侦察科学家还在他们的海报中描述了几项概念验证研究。

Its triplex STI assay, called STI Scout, detects CT/NG as well as an internal molecular control target. It uses crude first-void urine or vaginal swab samples and reports results in 30 minutes using three spectrally separated fluorescence channels. The assay, which is also shelf-stable and lyophilized, showed a high sensitivity and specificity in preliminary studies of spiked-in samples..

其三联STI检测方法，称为STI Scout，可检测CT/NG以及内部分子控制目标。它使用初次排尿的尿液或阴道拭子样本，并通过三个光谱分离的荧光通道在30分钟内报告结果。该检测方法在初步研究中对掺入样本显示出高灵敏度和特异性，并且具有货架稳定性并经过冻干处理。

With a four-target RT-LAMP respiratory panel, the team showed that loop-de-loop fluorescence brightness scales linearly with probe concentration but without any change in reaction speed. This property enables even higher multiplexing, Ball explained, because different targets can now be identified by color as well as by endpoint fluorescence brightness level.

通过四靶标RT-LAMP呼吸道检测板，团队展示了环状荧光亮度与探针浓度呈线性关系，而反应速度没有任何变化。Ball解释说，这一特性实现了更高的多重检测能力，因为现在可以通过颜色以及终点荧光亮度水平来区分不同的靶标。

.

。

The respiratory panel, called Respiratory Scout, detects influenza A, influenza B, SARS-CoV-2, and an internal control target in 30 minutes.

名为Respiratory Scout的呼吸系统检测板可在30分钟内检测甲型流感、乙型流感、SARS-CoV-2以及内部对照目标。

Meanwhile, a quadruplex rhinovirus assay called Rhino Scout, showed sensitivity comparable to the BioMérieux BioFire Spotfire respiratory panel. The test detects three types of rhinovirus plus an internal process control.

同时，一种名为Rhino Scout的四重鼻病毒检测方法显示出与BioMérieux BioFire Spotfire呼吸道检测板相当的灵敏度。该测试可检测三种类型的鼻病毒以及一个内部过程控制。

Scout is currently working with Altesa BioSciences, according to the poster, to offer Rhino Scout for research-use-only clinical stage development. Altesa is currently in Phase IIb clinical trials for its novel antiviral, vapendavir, which can prevent rhinovirus from entering human cells, according to the firm's website.

根据海报，Scout目前正与Altesa BioSciences合作，提供仅供研究使用的Rhino Scout用于临床阶段开发。Altesa目前正在对其新型抗病毒药物vapendavir进行IIb期临床试验，据该公司网站称，该药物可以阻止鼻病毒进入人体细胞。

.

。

Providing RUO custom testing to support pharma and vaccine research and development has actually helped the firm generate revenues to support its business to date, Jiao said.

焦说，为制药和疫苗研发提供RUO定制测试实际上帮助公司产生了支持其业务发展的收入。

Finally, with an assay called Avian Scout, the firm was able to prove it could go from a concept to a research-use-only RT-LAMP test ported onto the Scout platform in about six weeks.

最终，通过一种名为 Avian Scout 的检测方法，该公司能够证明它可以在大约六周内从一个概念发展到研究专用的 RT-LAMP 检测，并移植到 Scout 平台上。

Compared to a published fluorescent RT-LAMP assay specific for H5N1

与已发表的针对H5N1的荧光RT-LAMP检测方法相比

clade 2.3.4.4b

进化枝 2.3.4.4b

sequence, Scout showed that the loop-de-loop chemistry was twice as fast and between 10 to 100 times more sensitive, depending on viral titer. Similarly, an RT-LAMP

序列，Scout 表明环状化学反应的速度快了一倍，并且根据病毒滴度的不同，灵敏度提高了10到100倍。同样地，RT-LAMP

assay

测定

using SYTO9 intercalating dye from researchers in France was recently shown to detect clade 2.3.4.4b H5 from pooled poultry samples in 30 minutes with sensitivity of 86 percent while, by comparison, the Avian Scout test showed a time to positivity of between 10 to 15 minutes in the firm's proof-of-concept studies.  .

使用法国研究人员的SYTO9嵌入染料最近被证明可以在30分钟内从混合家禽样本中检测到2.3.4.4b H5分支，灵敏度为86％，而相比之下，Avian Scout测试在公司的概念验证研究中显示阳性时间在10到15分钟之间。

Importantly, the Avian Scout test kit was able to be integrated with the firm's reader device and mobile app within the six-week pilot project.

重要的是，禽类侦察测试套件能够在六周的试点项目中与公司的读取设备和移动应用程序集成。

Pros of a reader

读者的优点

The pandemic-era boom in the over-the-counter molecular testing space has shifted dramatically in the past year, and only a handful of over-the-counter molecular tests are currently commercially available. Similarly, firms focused on CLIA-waived, rapid point-of-care systems for use in urgent care clinics and physician offices also seem to be feeling the post-COVID pinch..

疫情期间，在柜台分子检测领域的繁荣在过去一年中发生了巨大的变化，目前只有少数几个柜台分子测试产品在商业上可用。同样，专注于CLIA豁免、快速即时检测系统，用于紧急护理诊所和医生办公室的公司似乎也感受到了后疫情时代的压力。

Among the POC MDx companies surviving the extinction event are

在POC MDx公司中，熬过灭绝事件的包括

Aptitude Medical

天赋医疗

,

，

Visby Medical

维斯比医疗

,

，

PlusLife

普鲁斯莱夫

,

，

Anavasi Diagnostics

阿纳瓦西诊断学

, and

，以及

Detect Diagnostics

检测诊断

. There are also innovative new molecular systems in development from

。还有一些正在开发中的创新分子系统

Credo Diagnostics

我相信诊断

,

，

Kryptos Biotechnologies

克里普托斯生物技术公司

, and

，以及

Cubit Diagnostics

立方体诊断

, and a host of

，以及许多

amplification-free

无扩增的

technologies on the horizon.

即将到来的技术。

On the other hand, some early beneficiaries of pandemic-era need for rapid molecular COVID testing have not fared as well. Talis Biomedical, for example, is no longer operating as a public company, while

另一方面，一些早期受益于疫情时期对快速分子新冠检测需求的公司表现不佳。例如，Talis生物医学公司已不再作为上市公司运营，而

Cue Health

检测健康

declared bankruptcy, and Pfizer's

宣布破产，以及辉瑞的

Lucira Health

吕西拉健康

subsidiary will be shuttering by the end of this year. Meanwhile, messages to

子公司将在今年年底前关闭。与此同时，消息显示

3EO Health

3EO健康

are currently forwarded to a consultancy firm that offers bankruptcy and insolvency services.

目前被转交给一家提供破产和资不抵债服务的咨询公司。

For over-the-counter, at-home molecular tests, in particular, the incorporation of a reader device that customers need to purchase and keep in their homes has been considered a potential hurdle for adoption.

特别是对于非处方的家用分子检测，需要消费者购买并存放在家中的读取设备被认为是阻碍其普及的一个潜在障碍。

Michael Mina, an epidemiologist who publicly advocates for expanded decentralized testing and who serves as a scientific adviser to Scout Health,

迈克尔·米纳，一位公开倡导扩大分散式检测的流行病学家，同时担任Scout Health的科学顾问，

said

说

in a recent interview that consumers seem hesitant to purchase a device that reminds them they may need to do infectious disease testing in the future. Still, molecular testing is highly accurate, and '

在最近的一次采访中表示，消费者似乎对购买一种提醒他们未来可能需要进行传染病检测的设备持犹豫态度。尽管如此，分子测试仍然具有高度准确性，而且

it is r

它是 r

eally important to help curb transmission and keep people empowered over their health care,' Mina said.

“真的很重要，有助于遏制病毒传播，让人们掌控自己的医疗保健，”米娜说。

Jiao and Ball also believe that certain consumers who require frequent testing are more likely to be psychologically aligned with owning a reader, and Scout is currently pursuing niche assays that can cater to these potential users.

焦和鲍尔还认为，某些需要频繁检测的消费者更有可能在心理上倾向于拥有一台阅读器，而Scout目前正在追求能够迎合这些潜在用户的利基检测方法。

In the traditional point-of-care space, a reader is also a benefit, as it can connect to a health system's network or public health reporting site, Jiao said.

焦说，在传统的即时检验空间中，读卡器也是一种好处，因为它可以连接到健康系统的网络或公共卫生报告站点。

For the OTC space, the reader can also store and track a patient's test data and enable patients to send it to their clinicians.

对于OTC领域，该读卡器还可以存储和跟踪患者的测试数据，并允许患者将其发送给临床医生。

Jiao said the firm was not yet in a position to cite a sales price for the reader, or hub, but noted the cost would be in the range of a co-pay and approximately twice the cost of the test consumables.

焦表示，公司目前还不能透露该阅读器或中心的价格，但指出其成本将相当于一次挂号费的范围，大约是测试耗材成本的两倍。

'We see the hub aspect as a net positive, because it opens up a lot of other opportunities,' Jiao said. 'It's part of what we think is coming for digital health in general,' he added.

“我们认为枢纽方面是一个净积极因素，因为它开辟了许多其他机会，”焦说。“这是我们对数字健康未来发展的整体看法的一部分，”他补充道。

After proving itself through the US Food and Drug Administration EUA regulatory process and demonstrating it can develop new assays very rapidly, Scout is currently in initial conversations with potential investors and partners.

在通过美国食品药品监督管理局（FDA）的紧急使用授权（EUA）监管程序证明自身实力，并展示其能够非常迅速地开发新检测方法后，Scout目前正在与潜在投资者和合作伙伴进行初步洽谈。

Investors may currently be more hesitant about molecular testing, given companies going under and a lack of IPO wins, Jiao said, and they may be looking for technical de-risking and perhaps partnerships.

焦说，鉴于一些公司倒闭和缺乏首次公开募股的胜利，投资者目前可能对分子测试更加犹豫，他们可能在寻找技术上的风险降低，也许是合作关系。

However, investors are also aware of the power of point-of-care molecular testing. 'They understand that this is where the future is headed,' he said.

然而，投资者也意识到了床旁分子检测的力量。他表示：“他们知道这就是未来的方向所在。”