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Rapid Tests Continue Push Into Sepsis Market in 2023 as Competition Heats Up

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Sepsis

NEW YORK – 2023 saw the continued development of new technologies for diagnosing sepsis with the goal of improving treatment of the often deadly condition.

Diagnostic industry startups and stalwarts alike made strides in 2023 on the development or launch of tests that would introduce new methods to aid diagnosis of sepsis, which is typically identified through symptomatic evaluation and blood tests for markers of infection, as well as identification of the type of organism responsible for the infection.

While firms have been working for several years to improve tests for diagnosing and detecting sepsis, current methods for determining whether an individual has sepsis largely remain a slow process, putting patients at risk. According to the US Centers for Disease Control and Prevention, at least 1.7 million adults in the US is affected by sepsis, which is linked to about one in three deaths in US hospitals.

Newer methods aim to bypass the need to culture patient samples, shortening the time to result, improve accuracy, better determine whether an infection is bacterial or viral in nature, and help determine how a patient may respond to specific treatments.

For example, Inflammatix said in late 2023 that it was preparing to launch in 2024 a 30-minute blood-based test that could help emergency room physicians during triage of patients with suspected sepsis and other acute infections. The test can help healthcare providers differentiate between bacterial and viral infections as well as generate risk scores for the likelihood a patient will develop in coming days severe disease that will require interventions such as mechanical ventilation or renal replacement therapy.

The Stanford University spinout said in November that the US Food and Drug Administration had granted breakthrough device designation for the TriVerity Acute Infection and Sepsis Test System, which the company intends to launch in the fourth quarter of 2024.

Inflammatix Cofounder and CEO Tim Sweeney said this fall that the TriVerity test is used to generate scores on the likelihood that a patient has a bacterial infection, a viral infection, and a severe illness that will require interventions. It involves mRNA extraction and isothermal amplification on a disposable test cartridge and determines gene expression using quantitative real-time RT-LAMP on Inflammatix's Myrna instrument.

Early in the year, Immunexpress began US commercialization of its FDA-cleared qPCR-based SeptiCyte Rapid assay, which provides near-patient results within one hour. The test is used to differentiate the expression of two genes, phospholipase A2 group VII platelet activating factor (PLA2G7) and placental-specific 8 (PLAC8) and indicate whether the inflammatory response is characteristic of sepsis compared to a general systemic inflammatory response.

Immunexpress CEO Rollie Carlson said at the time that the test is meant primarily to generate risk scores to indicate the likelihood of sepsis among people arriving in an ICU. Clinicians, he added, have been the most interested in using it to assess post-operative patients.

That test has been available in Europe since 2020 and was cleared by the FDA in 2021, and company officials said US commercialization was delayed by the need to scale up manufacturing and the difficulties in accessing hospitals and customers during the COVID-19 Omicron surge.

Saluggia, Italy-based DiaSorin also secured in the spring CE marking for a biomarker-based chemiluminescent immunoassay that is designed to stratify patients by disease severity and the risk of unfavorable outcomes. The firm plans to launch the Liaison BRAHMS MR-proADM assay in the US in the second half of 2024 to aid diagnosis of severe conditions including sepsis, septic shock, kidney diseases, and lower respiratory and urinary tract infections.

The FDA more recently granted 510(k) clearance for Ad Astra Diagnostics' rapid point-of-care hematology analyzer instrument that can help identify when infections develop into sepsis, among other applications. The Morrisville, North Carolina-based firm's QScout RLD (rapid leukocyte differential) instrument is used in part to measure immature granulocyte levels, whose changes may be an early marker of sepsis.

Ad Astra officials said the results can help healthcare providers identify sepsis up to 24 hours earlier than measuring lactate and procalcitonin.

Another firm, Cytovale, boasts a test that can provide results in about the time it takes to order a coffee at Starbucks. This summer it launched its FDA 510(k)-cleared IntelliSep prognostic blood test, which is used to stratify patients by sepsis risk, with results in 10 minutes. The firm's testing system measures immune cell activity associated with the dysregulated host response to sepsis by using high-speed imaging and machine learning to assess the mechanical properties of individual cells.

Company officials said ahead of the launch that the IntelliSep test can improve patient outcomes and resource use and estimated a hospital would save about $9 for every $1 spent on IntelliSep testing.

The firm developed, tested, and launched the test with $9 million in support from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority as well as support from private investors. Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, was Cytovale's first customer for the IntelliSep test. 

Some companies are also trying to improve existing sepsis testing processes or give healthcare providers additional information that can help them select the best treatment.

Siemens Healthineers recently said it secured a three-year, $5.5 million contract with the National Institute of Allergy and Infectious Diseases to develop a next-generation sequencing-based test that could within six hours of a blood draw identify the bacteria and fungi in a patient's bloodstream and indicate the likely resistance to certain antimicrobials. That project is a collaboration with Janus-I Science and the Louis Stokes Cleveland Department of Veterans Affairs Medical Center.

Dutch startup Nostics intends to follow up on the upcoming launch of its miniaturized point-of-care bacteria lab with a test to identify sepsis from a positive blood culture. The firm plans to initially commercialize its Colony-ID spectroscopy instrument with tests to identify the bacterial causes of urinary tract infections and sexually transmitted infections in plated culture.

The competition in the sepsis testing market looks to intensify as more of the R&D projects that are aimed at improving sepsis treatment turn toward commercial launches. Examples include Cambridge, UK-based EDX Medical, which is developing a series of lateral flow assays starting with a test for biomarkers associated with elevated risk of developing sepsis. EDX CEO Mike Hudson said this fall that the firm's point-of-care tests will use arrays of miniaturized testing dots to provide multiplexing capabilities and deliver results in about 15 minutes.

Oxford Nanopore Technologies and Day Zero Diagnostics also agreed in November to develop a diagnostic solution that would provide culture-free, same-day identification of bloodstream infections with genomics-based antibiotic susceptibility profiling. The system will incorporate DZD's sample preparation technology and its AI-supported microbial identification and antibiotic susceptibility pipeline with Oxford Nanopore's PromethIon 2 Solo sequencer.

Lexington, Massachusetts-based T2 Biosystems, which gained in September 510(k) clearance for its T2Biothreat Panel, said it has been eyeing an expansion of its sepsis testing offerings with a direct-from blood test that would simultaneously detect 13 antibiotic resistance genes and help guide sepsis treatment. The firm's T2Bacteria test is already used for sepsis detection.

Other firms signaled this year that they, too, see opportunities to apply their technologies to sepsis within their pipelines of upcoming tests.

Blu Biotech, for example, has partnered with the University of Michigan to develop multiplex gas chromatography-based breath tests for volatile organic compound patterns distinct to diseases including sepsis, colorectal and lung cancer, and COVID-19. Also, Bio-Techne is working to expand into clinical diagnostics with its Ella immunoassay analyzer and is conducting clinical studies on the use of that platform for diagnosis of sepsis and other diseases. And epigenetics firm VolitionRx secured this year a mix of income from grants and public offerings that the firm is using to support development of its Nu.Q nucleosome quantification program and assays to aid diagnosis and monitoring of cancers and infectious diseases such as sepsis.

Another project that gained funding in 2023 could also help improve understanding of why patients develop sepsis and how best to treat them. University of Illinois spinout Prenosis, which secured in June a $749,000 BARDA contract to demonstrate the clinical value of its AI/machine learning-developed Sepsis ImmunoScore software for predicting sepsis, said in July it would use $4.8 million in Small Business Innovation Research funding for studies that could "usher in a new era of predictive diagnostics, clinical decision support tools, improved clinical trials, and precision medicine drugs for sepsis."

The firm, like others immersed or entering the sepsis testing space, said it aims to deliver more efficient treatment that is tailored to each patient.