NEW YORK – In 2024, firms in the sepsis testing space made big moves to begin or expand the commercialization of tests that could help reduce the time-to-results, while many also secured funding to compete in an increasingly crowded space.

纽约——2024年，脓毒症测试领域的公司采取了重大举措，开始或扩大测试的商业化，这可能有助于缩短测试结果的时间，同时许多公司也获得了资金，以在日益拥挤的空间中竞争。

The emergence of rapid risk stratification tests, including molecular assays, has the potential to give hospitals a new option to determine how aggressively they can treat patients who have suspected sepsis or other severe infections.

包括分子检测在内的快速风险分层测试的出现，有可能为医院提供一种新的选择，以确定他们可以如何积极治疗疑似败血症或其他严重感染的患者。

Just in the past month, Chicago-based startup Prenosis said that it was preparing for clinical implementation of its AI-developed Sepsis ImmunoScore Software that is used to analyze biomarkers and clinical data to generate a risk score of patients' likelihood of developing sepsis.

就在过去一个月，总部位于芝加哥的初创公司Prenosis表示，它正在准备临床实施其AI开发的败血症免疫评分软件，该软件用于分析生物标志物和临床数据，以生成患者发生败血症可能性的风险评分。

Interest in the sepsis testing space was borne out by investments to companies developing tests to get faster results and improvement management of sepsis patients.

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For example, San Francisco-based Cytovale received $184 million from its two most recent funding rounds to support the expanded commercialization of its IntelliSep prognostic test that uses high-speed imaging and machine learning for the analysis of cell morphology and immune cell activation. The blood-based semiquantitative test is used to help emergency departments stratify patients by their sepsis risk and provides results in less than 10 minutes, .

例如，总部位于旧金山的Cytovale最近两轮融资获得1.84亿美元，以支持其IntelliSep预后测试的扩大商业化，该测试使用高速成像和机器学习来分析细胞形态和免疫细胞活化。基于血液的半定量测试用于帮助急诊科根据脓毒症风险对患者进行分层，并在不到10分钟内提供结果。

According to Cytovale officials, the test results were being used at its leading partner hospital in Louisiana, Our Lady of the Lake Regional Medical Center, to save an average of one life per week. The company expects to publish in early 2025 the results of a study with Johns Hopkins University on the impact of serial testing.

据Cytovale官员称，该公司位于路易斯安那州的主要合作伙伴医院湖区圣母医疗中心正在使用检测结果，平均每周挽救一条生命。该公司预计在2025年初公布与约翰·霍普金斯大学（JohnsHopkinsUniversity）合作的一项关于系列测试影响的研究结果。

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Meanwhile, Stanford University spinout Inflammatix has been preparing to launch a 30-minute test for the simultaneous determination in a blood sample of infection type and severity. By September, the firm had raised more than $200 million in private capital, including $57 million from a recent Series E funding round, as well as more than $50 million in grants and contracts.

与此同时，斯坦福大学spinout Inflammatix已准备启动一项30分钟的测试，以同时测定感染类型和严重程度的血液样本。截至9月，该公司已筹集到2亿多美元的私人资本，其中包括最近一轮E系列融资中的5700万美元，以及5000多万美元的赠款和合同。

The firm said that it would use the proceeds of its most recent funding round to support regulatory filings and commercialization of the test. .

该公司表示，它将使用最近一轮融资的收益来支持监管备案和测试的商业化。

The outlook for 2025

2025年展望

According to Craig Steger, managing director at Outcome Capital, 2024 saw more activity in the sepsis testing space, and he noted the significant financial backing secured by test developers who are pursuing commercialization. He added that the emerging tests that are used to stratify patients by risk scores will impact the market, allowing healthcare providers to more easily determine when to pursue additional testing as well as whether to start treatments more quickly..

根据Outcome Capital董事总经理克雷格·斯特格（CraigSteger）的说法，2024年脓毒症测试领域的活动越来越多，他注意到追求商业化的测试开发人员获得了巨大的资金支持。他补充说，用于根据风险评分对患者进行分层的新兴测试将影响市场，使医疗保健提供者能够更轻松地确定何时进行额外测试以及是否更快地开始治疗。。

Steger said that he expects new tests will emerge in the next few years to quickly identify the pathogens and drug resistances for the patients who are likely to develop sepsis, but those tests likely will be deemed too costly for their use in all patients with suspected sepsis. If risk scoring tests are used first, doctors can better identify which patients should receive the more expensive tests, he said..

斯特格说，他预计未来几年将出现新的检测方法，以快速识别可能发生败血症的患者的病原体和耐药性，但对于所有疑似败血症的患者来说，这些检测方法可能被认为成本过高。他说，如果首先使用风险评分测试，医生可以更好地确定哪些患者应该接受更昂贵的测试。。

He noted, however, that downstream healthcare economic costs are not always considered when providers are comparing the costs of a test, and identifying which patients have sepsis or are likely to develop sepsis could reduce the durations of hospital stays, resulting in healthcare cost savings.

然而，他指出，当提供者比较测试成本时，并不总是考虑下游医疗保健的经济成本，并且确定哪些患者患有败血症或可能患有败血症可以缩短住院时间，从而节省医疗保健成本。

Approvals and clearances

批准和许可

2024 also saw numerous regulatory approvals and clearances that paved the way for new sepsis testing technology to hit the market. Molecular diagnostics firm Immunexpress received expanded FDA clearance in December 2023 for its SeptiCyte Rapid sample-to-answer test, and regulatory clearance from Australia's Therapeutic Goods Administration in January 2024.

2024年还获得了众多监管部门的批准和批准，为新的败血症检测技术推向市场铺平了道路。分子诊断公司Immunexpress于2023年12月获得FDA扩大的脓毒症快速样本应答测试许可，并于2024年1月获得澳大利亚治疗用品管理局的监管许可。

More recently, the firm announced that study results published in the Journal of Clinical Medicine show that SeptiCyte Rapid was able to consistently discriminate between sepsis and systematic inflammatory response syndrome and to stratify patients by clinical severity..

最近，该公司宣布，发表在《临床医学杂志》上的研究结果表明，败血症快速能够持续区分败血症和系统性炎症反应综合征，并根据临床严重程度对患者进行分层。。

Company officials said early this year that they were focused on the hospital market although elder care and long-term care providers have expressed interest in using the system.

公司管理人员今年早些时候表示，他们专注于医院市场，尽管老年护理和长期护理提供者表示有兴趣使用该系统。

Also, this fall Accelerate Diagnostics secured US FDA 510(k) clearance for its automated blood culture sample preparation platform that is used to shorten the time to result for microbial identification tests and aid the treatment of sepsis. The firm's Accelerate Arc System is used to eliminate the need for overnight culture and lab developed test-related sample preparation methods.

此外，今年秋季Accelerate Diagnostics确保了美国FDA 510（k）对其自动血培养样品制备平台的批准，该平台用于缩短微生物鉴定测试的结果时间并帮助治疗败血症。该公司的加速电弧系统用于消除过夜培养和实验室开发的测试相关样品制备方法的需要。

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Accelerate also said that it is conducting clinical trials to support an FDA 510(k) submission for its Accelerate Wave antimicrobial susceptibility testing system, which would be used with the Accelerate Arc System to deliver same-shift antimicrobial susceptibility test results.

Accelerate还表示，它正在进行临床试验，以支持FDA 510（k）提交的Accelerate Wave抗菌药物敏感性测试系统，该系统将与Accelerate Arc系统一起使用，以提供相同的抗生素敏感性测试结果。

Meantime, T2 Biosystems nabbed FDA clearance in early 2024 for an extended version of its T2Bacteria syndromic panel for the detection of pathogens that cause bloodstream infections. The test uses the firm's magnetic resonance technology and PCR and is performed on its T2Dx Instrument, with results in three to five hours.

与此同时，T2生物系统公司在2024年初获得了FDA的批准，用于检测引起血流感染的病原体的T2Bacteria综合征小组的扩展版本。该测试使用该公司的磁共振技术和PCR，并在其T2Dx仪器上进行，结果在三到五个小时内完成。

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Swiss diagnostics firm Abionic announced in October that it had received FDA 510(k) clearance for its IVD Capsule PSP point-of-care test for the early detection of sepsis. The test is used to measure levels of pancreatic stone protein (PSP) in capillary whole blood or venous whole blood, and it is performed on the company's AbioScope nanofluidics testing platform, with results provided in five minutes..

瑞士诊断公司Abionic于10月宣布，其IVD胶囊PSP即时检测试验已获得FDA 510（k）许可，用于早期发现败血症。该测试用于测量毛细血管全血或静脉全血中胰结石蛋白（PSP）的水平，并在该公司的AbioScope纳米流体测试平台上进行，结果在五分钟内提供。。

The company said at the time that study results show that levels of PSP, which is produced by the pancreas and immune cells in response to infections and inflammation, rise days before patients develop symptoms of sepsis. The firm has focused on commercializing its test and platform in Europe, but it has distribution channels around the world and it has been forming a commercialization strategy for the US market..

该公司当时表示，研究结果显示，胰腺和免疫细胞在感染和炎症反应中产生的PSP水平在患者出现败血症症状前几天上升。该公司专注于在欧洲将其测试和平台商业化，但它在世界各地都有分销渠道，并且一直在为美国市场制定商业化战略。。

DeepUll also recently received breakthrough device designation from the US FDA for a sepsis test that is used to detect pathogens directly from blood. The firm unveiled the UllCore BSI Test this spring along with the company's flagship UllCore molecular testing platform. UllCore BSI is a one-hour direct-from-blood multiplex PCR test that targets 95 percent of sepsis-causing pathogens and multiple antimicrobial resistance genes.

DeepUll最近还获得了美国FDA的突破性设备指定，用于脓毒症测试，该测试用于直接从血液中检测病原体。该公司于今年春天推出了UllCore BSI测试以及该公司的旗舰UllCore分子测试平台。UllCore BSI是一种一小时直接从血液中进行的多重PCR检测，针对95%的败血症病原体和多种抗菌药物耐药基因。

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The firm also said that it had raised more than €40 million since 2020 and was preparing for a fundraising round.

该公司还表示，自2020年以来，它已经筹集了4000多万欧元，并正在准备一轮融资。

Even more tests are coming into view as startup firms lay the foundations for the commercialization of new technologies for faster sepsis testing.

随着初创公司为更快的败血症检测新技术的商业化奠定基础，更多的检测正在出现。

Over the summer, Bluejay Diagnostics closed an $8.75 million public offering and said that the company would use the proceeds to fund clinical studies that are needed to obtain FDA approvals for its tests, among other things. The company, which went public in 2021, has been developing its Symphony IL-6 test that is used to measure the interleukin-6 biomarker for the triage and monitoring of patients with suspected sepsis, with results provided in about 20 minutes..

整个夏天，Bluejay Diagnostics完成了一笔875万美元的公开募股，并表示该公司将使用收益资助临床研究，这些研究需要获得FDA的测试批准。该公司于2021年上市，一直在开发其Symphony IL-6测试，用于测量白细胞介素-6生物标志物，用于疑似败血症患者的分类和监测，结果约在20分钟内提供。。

South Korean researchers also reported in July that they had developed a culture-free testing method that could reduce by 40 to 60 hours from the time to treatment of patients with suspected sepsis. The scientists from Seoul National University and the diagnostics firm QuantaMatrix said that their whole-blood-based pathogen identification and antimicrobial susceptibility profiling test uses a synthetic peptide to recover bacterial pathogens and provides results in about 13 hours..

韩国研究人员7月还报告称，他们开发了一种无培养检测方法，可以将疑似败血症患者的治疗时间减少40至60小时。首尔国立大学和诊断公司QuantaMatrix的科学家表示，他们基于全血的病原体鉴定和抗菌药物敏感性分析测试使用合成肽来恢复细菌病原体，并在大约13小时内提供结果。。

Seoul-based QuantaMatrix has licensed the technologies and plans to develop a fully automated instrument that will integrate pathogen detection, identification, and drug susceptibility profiling.

总部位于首尔的QuantaMatrix已获得这些技术的许可，并计划开发一种全自动仪器，该仪器将集成病原体检测，鉴定和药物敏感性分析。