Infectious Disease Diagnostics in 2025: Market Volatility Meets Rapid Technology Advancements

Original from: genomeweb

Following decades of cumulative efforts, a number of infectious disease tests and technologies broke new ground in 2025, hinting at rapid advances in the development of new systems and assays.

But the past year also saw its fair share of upheaval, possibly suggesting more may be in store in 2026.

After incremental advancements in the past few years, diagnostic approaches incorporating pathogen sequencing, syndromic testing, digital PCR, CRISPR, host-response testing, and multimodal instruments, for example, seemed to suddenly to reach new plateaus in 2025. At the same time, ongoing development in the diagnostics space, especially in rapid molecular testing and in tests for decentralized settings, was further catalyzed this year by new over-the-counter, at-home, and point-of-care test systems and assay clearances.

Among infectious diseases, tuberculosis' profile in particular rose in 2025, but not always for good reasons. Test availability and funding support for TB, as well as for HIV and antimicrobial resistance and susceptibility testing, faltered in 2025, following cuts to US aid programs.

The Trump administration early in the year terminated programs and funding that supported TB and HIV diagnostics, impacting a number of developers. Following pandemic-related reductions in TB diagnosis and care that led to a spike in infection rates, the most recent moves felt particularly fraught.

The recently published World Health Organization's 2025 global TB report offered hints that the governments of other countries and nonprofits may be stepping in to help fill the void, though it also asserted that global TB elimination milestones remain elusive.

Cassandra Kelly-Cirino, executive director of the International Union Against Tuberculosis and Lung Disease and former VP of health programs at diagnostics nonprofit FIND, believes it is time for governments to strengthen domestic funding and focus their resources on evidence-based strategies. The fact that millions are still at high risk of suffering from a preventable infectious disease such as tuberculosis is a "total injustice and failure by us all," she said in an email.

That said, new approaches to low-cost, rapid, and accurate TB testing advanced in 2025, and Kelly-Cirino highlighted a number of new technologies presented at the Union World Conference on Lung Health, in particular, including innovative tongue swab tests, portable molecular devices, and breath-based TB screening assays. "These new diagnostic breakthroughs reduce barriers to accurate testing, bringing us ever closer towards a TB-free future," she said.

As is the case with many other infectious diseases, ongoing scale-up of new technologies is encouraging, but, "If we are to truly turn the tide, we need to effectively implement existing recommendations with more urgency, such as rapid molecular diagnostic testing," Kelly-Cirino said. To her mind, the fact that only 54 percent of the 8.3 million people newly diagnosed with TB in 2024 got one of the dozen or so WHO-recommended rapid molecular tests is "unacceptable. Now is not the time to cut funding and engagement in the fight against TB - we can do that once the job is done," she added.

This year also saw the demise of antimicrobial susceptibility testing firms Accelerate Diagnostics and T2 Biosystems. Novel offerings from these companies were supported by clinical validations and utility studies as well as extensive federal and nonprofit funding. Although rapid AST and ID/AST adoption had shown signs of recovery following the Covid-19 pandemic, it stagnated in 2025, with even larger players like BioMérieux reporting slower-than-expected market growth following the rollout of its Vitek Reveal rapid antimicrobial susceptibility testing system.

On the other hand, new direct testing offerings from startups like Ocean Dx, Scanogen, and DNAe may now reinvigorate the infectious disease diagnostics space. The nanopore sequencing-based Ocean Dx assay, in particular, was able to identify three times as many sepsis cases than blood culture alone, according to a recent study.

In general, progress in targeted next-generation sequencing and pathogen-agnostic metagenomic sequencing for infectious diseases also seemed to come at a hastened clip in 2025, resulting in a number of new partnerships, products, and projects. For example, BioMérieux acquired Day Zero Diagnostics and its direct-from-blood pathogen sequencing assets in June, while Oxtord Nanopore Technologies partnered with Danaher subsidiary Cepheid in April to develop an infectious disease sequencing workflow. Oxford Nanopore also announced a deal with Credence Genomics in July and it made progress on sequencing-based tuberculosis testing during the year under a partnership with BioMérieux.

There was also an uptick in digital PCR applications for infectious diseases this year. A well-understood molecular tool with major advantages over standard real-time PCR, clinical dPCR development projects previously focused mainly on oncology and transplant monitoring, but a project from Brown University Health to develop a pneumonia test on Qiagen's QiAcuity-Dx system, in particular, may portend more infectious disease applications for the technology.

Several tests incorporating new methods and technologies also received premarket authorization and de novo clearance from the US Food and Drug Administration, including Visby Medical's disposable at-home PCR-based test for pathogens that cause chlamydia, gonorrhea, and trichomoniasis. The test was granted de novo clearance in April, and the San Jose, California-based company more recently opted to suspend clinical test manufacturing to focus all its efforts on nurturing the nascent over-the-counter molecular market.

In hot pursuit to pioneer the home-based molecular sexually transmitted infections testing business, Aptitude Medical, Scout Health and Kryptos Biotechnologies won new funding support this year to advance their rapid test systems. Similarly, having worked to build a CRISPR-based molecular STI test with funding from the Gates Foundation, Sherlock Biosciences' approach was validated, and in late 2024, the company was acquired by OraSure Technologies. Other CRISPR approaches to infectious diseases also made progress in 2025, as VedaBio advanced a 10-minute panel providing up to five results and covering 80 percent of the pathogens that cause respiratory infections.

But in a further sign of volatility in the market, at-home isothermal molecular testing firm Lucira Health was shut down this year, two years after being acquired by pharmaceutical firm Pfizer. In the bigger picture, health economics are key to test viability and scalability, as Alex de Winter, VP of Danaher Ventures, noted recently at investment bank Canaccord Genuity's forum on the expanding role of precision medicine. Since the cost of care and payer incentives vary by setting and specific ailment, he said, technologies merging rapid turnaround times with inexpensive pricing and an applicability to many pathogens may best align with infectious disease testing.

Indeed, in 2025 there were signs of shifts in the point-of-care molecular space toward broader test menus and higher multiplexing. For example, Roche got FDA clearance and CLIA waivers to detect three species of Bordetella simultaneously, as well as a test to detect three STls on its 20-minute Cobas Liat system.

The BioMerieux SpotFire, meanwhile, currently provides CLIA-waived multiplexing of up to 14 targets, and a head-to-head comparison of the Liat, SpotFire, and Cepheid GeneXpert recently showed the three systems had comparable performance. Launched less than three years ago, the SpotFire installed base grew to 5,500 instruments by the end of September, a notable feat given that other POC MDx firms have shuttered over the same timespan.

Only a few other true PCR point-of-care systems can perform high multiplexing in 20 minutes or less, including Babies' Finder and Lex Diagnostics' Velo. The latter was submitted to the FDA in June along with a test for influenza A, influenza B, and COVID-19, and QuidelOrtho is expected to acquire Lex upon clearance and CLIA waiver. Nuclein also aims to scale up the multiplexing of its recently CLIA-waived 15-minute PCR system, called DASH, from its current limit of four to as many as 10 targets.

Although Finder performs five-minute multiplex PCR testing, it is also among a handful of so-called multimodal systems that can perform chemistry, coagulation, and immunoassay testing. Multimodal system developers Cubit Diagnostics and Fluxergy, also made progress in 2025, and were slated to enter clinical trials to support their first FDA-cleared products.

But the growth in infectious disease testing wasn't specific only to molecular technologies. Advances in immunoassay testing also generated a buzz in 2025.

Roche struck a deal with Sapphiros in November to access up to 1 billion lateral flow tests per year using Sapphiros' high-volume reel-to-reel manufacturing methods. Meanwhile, Healgen Scientific's de novo clearance late last year for an over-the-counter combination antigen test to detect COVID, influenza A , and influenza B preceded Osang Health's 510(k) clearance for its own OTC Covid/flu combo test in January. Also, Sapphiros recently announced a partnership with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, or BARDA, to develop a single-use connected assay called the NowFuture Digital Flu/COVID Test.

Host-response testing was also in the spotlight this year as Lumos Diagnostics completed its CLIA waiver clinical trial of FebriDx, a test to distinguish viral from bacterial infections. The test has potential to reduce mortality, patient advocates have noted.

Sepset Bioscience, meanwhile, validated its host-response test for sepsis, while Inflamatix's TriVerity sepsis test, which detects 29 host immune markers, was granted 510(k) clearance in January and outperformed other biomarker testing in a study. published in September. Novel neonatal sepsis diagnostics were also the subject of CARB-X awards this year, with grants awarded to Melio, AstraDx, and QuantaMatrix, among others.

For clinicians diagnosing infectious diseases in 2026 and beyond, it now seems more likely than ever that new diagnostic technologies will increasingly impact patient care. For Kelly-Cirino, however, these advances will also need to translate globally to be truly impactful and meaningful, she noted.

Source: Infectious Disease Diagnostics in 2025: Market Volatility Meets Rapid Technology Advancements