NEW YORK – After going private in 2022 and rebranding in 2023, AliveDx has shifted its focus from transfusion testing to clinical testing with plans to soon launch in the US and EU an expanding menu of tests for autoimmune diseases and allergies, among others.

纽约——AliveDx 在2022年私有化并在2023年重塑品牌后，已经将其重点从输血检测转移到临床检测，并计划很快在美国和欧盟推出一系列扩展的自身免疫疾病和过敏等测试。

Formerly called Quotient Limited, the Switzerland-based firm said

总部位于瑞士的该公司，前称为Quotient Limited，表示

earlier this year

今年早些时候

that it had submitted for US Food and Drug Administration 510(k) marketing clearance its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray assay that is used to aid the diagnosis of autoimmune rheumatic diseases. The firm already

该公司已向美国食品和药物管理局提交了其MosaiQ AiPlex结缔组织疾病（CTDplus）微阵列检测的510(k)上市许可申请，该检测用于辅助诊断自身免疫性风湿病。公司已经

received CE marking

收到CE标志

under the EU's In Vitro Diagnostic Regulation (IVDR) for the test in February as well as CE-IVDR marking last year for two microarray immunoassays to aid the diagnosis of

根据欧盟体外诊断法规 (IVDR) 于今年二月对该测试进行认证，并且去年已获得两项用于辅助诊断的微阵列免疫分析的CE-IVDR标志。

allergies

过敏症

and

和

celiac disease

乳糜泻

.

。

Manuel O. Méndez, AliveDx CEO, said that the company can quickly develop new microarray assays for its MosaiQ fully automated microarray platform, which offers testing for up to 132 targets through two microarray-based testing chambers of up to 66 analytes or parameters each. He said that the development of a new 15-target microarray assay, for example, could be completed within two years, and he anticipates that speed will allow the company to continuously release new tests..

曼努埃尔·O.门德斯（Manuel O. Méndez），AliveDx首席执行官，表示公司可以迅速为其MosaiQ全自动微阵列平台开发新的微阵列检测方法。该平台通过两个基于微阵列的检测舱提供多达132个目标的检测，每个检测舱可检测多达66种分析物或参数。他提到，例如，一个包含15个目标的新微阵列检测方法的开发可以在两年内完成，他预计这种速度将使公司能够持续推出新的检测方法。

The company said on its website that the instrument also offers continuous random access and a throughput of up to 2,850 results per hour.

该公司在其网站上表示，该仪器还提供连续随机存取功能，每小时吞吐量高达2850个结果。

Quotient was a spinoff from the Scottish National Blood Transfusion Service, and Méndez said that the company designed MosaiQ to address the needs of the blood banking industry through QR code-based traceability for each microarray, high ease-of-use, and high walk-away time, with the ability to operate for eight hours without intervention.

Quotient 是从苏格兰国家血液 transfusion 服务中分离出来的，Méndez 表示，该公司设计 MosaiQ 是为了通过基于二维码的每个微阵列可追溯性、高易用性和高离机时间来满足血库行业的需求，并且能够无干预运行八小时。

.

。

Early adopters

早期采用者

primarily used it for blood grouping and the screening of donated blood, and the firm has said that the ability to perform multiplex testing for immunohematology, serology, and molecular biomarkers offered transfusion and diagnostic labs an option to replace several instruments.

主要用于血型分型和捐赠血液的筛查，该公司表示，能够进行免疫血液学、血清学和分子生物标志物的多重检测，为输血和诊断实验室提供了一个替代多种仪器的选择。

The company gained CE marking in 2018 for the MosaiQ instrument, in 2019 for an immunohematology microarray for use in transfusion diagnostics, and in 2020 for a serological disease screening microarray. In 2022, the firm

该公司在2018年获得了MosaiQ仪器的CE标志，2019年获得了用于输血诊断的免疫血液学微阵列的CE标志，2020年获得了血清疾病筛查微阵列的CE标志。2022年，该公司...

secured CE marking

获得CE标志

for an expanded panel for comprehensive blood typing and disease screening in samples of donated blood.

用于扩大的面板，以便对捐赠血液样本进行全面的血型分型和疾病筛查。

Méndez joined AliveDx in April 2021, and the firm soon decided to expand its reach into the clinical testing market.

门德斯于2021年4月加入AliveDx，该公司很快决定扩大其在临床测试市场的影响力。

'When I came in, I quickly started a program to address clinical needs and clinical opportunities, and one of the areas that we identified quickly was an area of autoimmune and allergy,' Méndez said.

“当我进来时，我迅速启动了一项针对临床需求和临床机会的计划，我们很快确定的一个领域是自身免疫和过敏领域，”门德斯说。

The firm

公司

announced in June 2022

2022年6月宣布

that it would partner with Theradiag to develop autoimmune diagnostics for the MosaiQ platform and it

它将与Theradiag合作，为MosaiQ平台开发自身免疫诊断产品，并且

said that July

表示那年七月

that it was partnering with Infynity Biomarkers to develop infectious disease tests for the MosaiQ platform.

它将与Infynity Biomarkers合作，为MosaiQ平台开发传染病检测方法。

However, Méndez said that capital markets dried up in 2022, delaying decisions and contracts for testing products, and Quotient had a hard choice whether to focus the MosaiQ solution on blood banks or clinical testing, where the firm ultimately saw greater opportunities and a faster pathway to growth and profitability, he said..

然而，门德斯表示，2022年资本市场枯竭，导致产品测试的决策和合同被推迟。门德斯还称，Quotient面临一个艰难的选择，即是否将MosaiQ解决方案专注于血库还是临床测试。该公司最终认为，在临床测试领域有更大的机会以及更快的增长和盈利途径。

'We couldn't do both at the same time,' he said.

“我们无法同时做到这两点，”他说。

In June 2022, the company

2022年6月，该公司

reported

已报告

that its revenues for the fiscal year ended March 31 had fallen 11 percent, to $38.5 million from $43.4 million, on lower MosaiQ sales as well as a decline in other revenues. The firm posted a net loss for the year of $125.1 million, or $1.23 per share.

截至 3 月 31 日的财政年度，其收入下降了 11%，从 4,340 万美元降至 3,850 万美元，原因是 MosaiQ 销售额下降以及其他收入减少。该公司全年净亏损 1.251 亿美元，即每股亏损 1.23 美元。

By November 2022, the firm had enacted a 1-for-40 reverse split of its ordinary shares to bring it into compliance with the minimum bid price requirement to remain listed on the Nasdaq. The following month, it voluntarily

截至2022年11月，该公司已对其普通股进行了1比40的反向分股，以符合继续在纳斯达克上市的最低出价要求。次月，该公司自愿

delisted its shares

退市其股票

and laid off 100 employees.

并解雇了100名员工。

Quotient leaders had consulted with investors and decided to take the company private with plans to soon relaunch with a new focus on clinical diagnostics, Méndez said. The firm remains in the blood banking testing space, though, through its Alba business's line of manual blood grouping and typing products as well as the manufacture of controls for other firms in the space..

Méndez 表示，Quotient 的领导层已与投资者协商，决定将公司私有化，并计划很快重新推出，专注于临床诊断。不过，该公司仍通过其 Alba 业务的手动血型分组和血型鉴定产品系列，以及为该领域的其他公司生产质控品，继续留在血液银行检测领域。

'We still kept our Alba Bioscience business as core to the blood banking business, and we've grown that business significantly, and those relationships have continued to flourish in the blood banking area for Alba Bioscience,' he said. 'But then, we decided to focus the MosaiQ purely, initially, on autoimmune and allergy and then expand into other areas.'.

“我们仍然将Alba Bioscience业务作为血液银行业务的核心，并且我们已经显著扩展了该业务，Alba Bioscience在血液银行领域的这些关系也持续得到了发展，”他表示。“但是，我们决定首先将MosaiQ完全专注于自身免疫和过敏领域，然后再扩展到其他领域。”

Since the company went private, investors have provided sufficient funding for a runway to commercialize its new testing lineup, Méndez said. He declined to disclose the funding amounts.

门德斯表示，自从公司私有化以来，投资者已经为该公司新测试系列的商业化提供了充足的资金支持。他拒绝透露具体融资金额。

'There are no concerns in terms of funding for our company, and we're very grateful,' he said.

“我们的公司在资金方面没有问题，我们非常感激。”他说。

Following the CE-IVDR marking of the firm's celiac disease and connective tissue disease panels, AliveDx expects to bring to market within the next few months a pair of panels for vasculitis and antiphospholipid syndrome. The company also is developing a liver disease panel to launch in late 2026 or the first half of 2027..

在公司乳糜泻和结缔组织疾病检测面板获得CE-IVDR标志后，AliveDx预计将在未来几个月内推出两款用于血管炎和抗磷脂综合征的检测面板。该公司还在开发一款肝脏疾病检测面板，计划于2026年底或2027年上半年推出。

It also expects to secure in 2026 CE-IVDR marking for an autoimmune panel to differentiate Type 1 and 2 diabetes with results in one hour, which would represent a quicker result than the overnight incubation that is typical for ELISA-based testing. The faster testing process would help to improve testing efficiency and reduce misdiagnosis, and the firm expects to bring the test to the US market soon afterward, Méndez said..

它还预计将在2026年获得自身免疫面板的CE-IVDR标志，用于在一小时内区分1型和2型糖尿病，这将比典型的基于ELISA的测试所需的过夜孵育更快。门德斯表示，这种更快的测试流程将有助于提高测试效率并减少误诊，公司预计很快会将该测试引入美国市场。

While the firm already secured a CE-IVDR clearance for an allergy test, the firm expects to also gain this year the EU and US regulatory clearances to launch its updated 34-target IgE antibody-based AllergyPlex Combo immunoassay, which is used to aid the diagnosis of nine major food allergies and 24 common respiratory allergies..

虽然该公司已经为其过敏测试获得了CE-IVDR认证，但公司预计今年还将获得欧盟和美国的监管批准，以推出其更新的基于34靶点IgE抗体的AllergyPlex Combo免疫测定产品，该产品用于辅助诊断九大主要食物过敏和24种常见呼吸道过敏。

The firm also has developed its LumiQ benchtop immunofluorescence instrument that is used in autoimmune disease testing workflows to perform antibody screening ahead of confirmatory testing with the MosaiQ instrument. That instrument is CE marked under the EU's older IVD Directive and sold in countries recognizing the CE mark..

该公司还开发了其LumiQ台式免疫荧光仪器，该仪器用于自身免疫疾病检测工作流程中，在使用MosaiQ仪器进行确认性测试之前执行抗体筛查。该仪器根据欧盟较旧的体外诊断指令（IVD Directive）获得了CE标志，并在承认CE标志的国家销售。

Méndez said that the firm also has received approval from Brazil's health regulatory agency for the MosaiQ instrument, reagents, and AiPlex CD panel for celiac disease, as well as submitted for approval its AiPlex CTDplus panel for connective tissue diseases, with submissions for its vasculitis and antiphospholipid syndrome tests to soon follow.

门德斯表示，该公司还获得了巴西卫生监管机构对 MosaiQ 仪器、试剂和用于乳糜泻的 AiPlex CD 面板的批准，并已提交用于结缔组织病的 AiPlex CTDplus 面板的审批申请，其血管炎和抗磷脂综合征测试的提交也将很快跟进。

He noted that the firm also has registered elements of its platform elsewhere in the Asia-Pacific and Middle East regions..

他指出，该公司还在亚太地区和中东地区的其他地方注册了其平台的元素。

Méndez said that the firm's autoimmune disease panels use biomarker combinations to help clinicians differentiate between diseases with often overlapping clinical signs. Early diagnosis, he said, can inform treatment decisions and help avoid irreversible organ damage.

门德斯表示，该公司的自身免疫疾病检测面板使用生物标志物组合来帮助临床医生区分常常具有重叠临床症状的疾病。早期诊断，他说，可以指导治疗决策，并有助于避免不可逆的器官损伤。

'Multiplexing and running the panel is so critical because then you're able to see these markers ahead of symptoms and ahead of permanent damage to the organs,' he said.

“多路复用和运行这个检测板非常关键，因为这样你就可以在症状出现之前和器官受到永久性损伤之前看到这些标志物，”他说道。

Méndez said that the company continues to try to convince healthcare providers of the value of its platforms with a goal this year of publishing more than 20 scientific articles this year, matching its volume of publications in 2024. Meanwhile, the firm has started negotiations with more than 50 hospitals and healthcare systems globally about the use of the firm's testing platforms..

门德斯表示，公司将继续努力向医疗保健提供商证明其平台的价值，今年的目标是发表 20 多篇科学文章，与 2024 年的出版量相当。同时，该公司已开始与全球 50 多家医院和医疗系统就使用该公司的检测平台展开谈判。

The company also is working with an artificial intelligence firm, which Méndez declined to name, on software that could help clinicians to decide which tests to perform if they suspect an autoimmune disease, interpret the test results, and identify potential treatments. The MosaiQ instrument currently reports the individual results for each marker for clinicians to interpret..

该公司还与一家人工智能公司合作，门德斯拒绝透露其名称，开发一款软件，可以帮助临床医生决定如果怀疑自身免疫性疾病应该进行哪些测试、解读测试结果并确定潜在的治疗方法。MosaiQ仪器目前报告每个标记的单项结果，供临床医生解读。

AliveDx intends to sell the MosaiQ system mainly to reference and hospital labs, and Méndez said that the firm has been in conversations with some of the major players in the US, European, and Latin American markets as well as inked deals to place instruments in some hospital systems. He noted that Laboratory Corporation of America has a seat on the company's scientific advisory board..

AliveDx 打算将 MosaiQ 系统主要销售给参考实验室和医院实验室，门德斯表示，公司已与美国、欧洲和拉丁美洲市场的一些主要参与者进行了洽谈，并签署了在一些医院系统中放置仪器的协议。他指出，美国实验室公司（Laboratory Corporation of America）在公司的科学顾问委员会中占有一席之地。

AliveDx also has begun feasibility testing for neurology and reproductive health tests. Méndez noted that the company has started work with a firm on the development of a panel test that could be used to identify protein signatures for the diagnosis of neurodegenerative conditions such as Alzheimer's and Parkinson's diseases..

AliveDx 还开始对神经病学和生殖健康测试进行可行性研究。门德斯指出，该公司已开始与一家公司合作开发一种面板测试，可用于识别蛋白质特征，以诊断阿尔茨海默氏症和帕金森氏症等神经退行性疾病。

Meanwhile, the company has been in conversations with various payors about securing reimbursement for its tests, and he said that the company has been making the case that the tests will ultimately reduce healthcare spending through faster diagnosis and reduced time to begin treatments.

同时，该公司一直在与各种支付方进行谈判，以确保其测试的报销，并表示公司一直在表明这些测试将通过更快的诊断和缩短治疗开始时间来最终减少医疗支出。

'We cannot take the disease away but, if we can be a little…part in making that life a little bit better, I think we've done our job,' he said.

“我们无法彻底治愈这种疾病，但如果能在改善患者生活质量方面起到一点作用，我认为我们就已经完成了自己的工作。”他说。