The 2025 J.P. Morgan Healthcare Conference wrapped up, and while big pharma M&A received most of the attention this year, there was some under-the-surface news of note for the IVD industry. Here are a few nuggets:
Ozempic-Associated Proteomics Test? The trend of increased usage of semaglutide (Ozempic/Wegovy) cannot be ignored by any part of healthcare. Standard BioTools presented a study by Novo Nordisk, published in Nature Medicine, which utilized the company’s SomaScan proteomic technology to analyze over 6,000 proteins in a cohort of 1,900 patients treated with semaglutide. The research revealed proteomic mechanisms underlying the drug’s cardiovascular benefits.
Also revealed at the meeting: Illumina is preparing to launch a distributed proteomics assay combining SomaScan and next-generation sequencing.
Genomics and NGS “No Short-Term Threat” to MDX: There’s been increasing talk about bringing genomics to bear in in vitro diagnostics and even those systems replacing traditional molecular tests. bioMérieux CEO Pierre Boulud suggested that, in the short term, the focus of clinical testing for infectious disease will be on molecular systems.
“In this business not only the performance of the test is important, but also the capacity and cost. You have to optimize those three to be successful,” he said.
Molecular diagnostics optimizes those, and thus, Boulud said, bioMérieux didn’t see a threat “in the short term” However “at some point in the mid-term to long term” the company said they are seeing it as a “very interesting technology when it is fully automated.”
Boulud noted that the company owns 7% of Oxford Nanopore and cited MR TB as an area of testing.
The statement came in a Q&A session of the company’s talk at JPM, in which they revealed positive sales of molecular systems. The company announced that 3,000 units of its Spotfire Molecular CLIA-waived system had been sold, with 900 sales in Q4 2024 alone. The company said it expects 7% growth (next 4 years) growing sales of Spotfire, selling non-respiratory tests on its BIOFIRE system, and pushing microbiology test sales. It also noted it had cleared 40% growth in revenue since 2019.
Spin Chip Buy: bioMérieux does have immunoassay products and the company said the acquisition of SpinChip, a POC immunoassay company based in Oslo, Norway, is aimed at improving performance in that line of tests. Its tech, the company notes, performs 10-minute cardiac marker tests from a drop of blood. They plan a launch a product in 2026.
Human “Digital Twins Concept” Unveiled: NVIDIA and Mayo Clinic are partnering to develop “human digital twins,” virtual models that combine medical imaging, pathology, health records, and wearable data to simulate and optimize patient outcomes. These digital twins aim to transform clinical trials, medical training, and surgical planning, offering unprecedented precision in diagnosing and treating diseases. The collaboration will enhance Mayo Clinic’s digital pathology platform using NVIDIA’s DGX B200 supercomputers and MONAI, an open-source AI framework for medical imaging.
Thermo Highlights Proteomics: Thermo Fisher Scientific reported strong progress in proteomics and mass spectrometry, driven by its acquisition of Olink. The UK’s Biobank recently selected Olink’s platform to analyze plasma proteomes in 600,000 blood samples. That volume of blood samples from a diverse population, the company notes, should create a rich dataset that offers statistically significant insights across various health conditions. Proteomic insights can guide drug discovery efforts, enabling the development of treatments tailored to specific molecular targets. Researchers can improve risk assessment and early intervention strategies by identifying protein level patterns across a large population.
Strong Demand for Mass Spec: Thermo also highlighted robust demand for its mass spectrometry instruments, including the Stellar and Orbitrap Astral systems, which have solidified its position in high-end analytical instrumentation. Thermo Fisher also launched the One Lambda Transplant risk assay and the Stellar mass spectrometer last year. The firm’s analytical instruments business has performed well lately, driven by the Stellar and Orbitrap Astral mass spectrometers and the company said there was “incredibly strong demand” for these types of systems.
Hologic Ready to Buy: Hologic CEO Steve MacMillan pointed to the success of its $230 million acquisition of Biotheranostics in 2021, which has since tripled annual revenue to $100 million. He said the company has $2.4 billion in cash reserves available for future deals. MacMillan indicated plans to execute one midsize acquisition annually in each segment to sustain growth and capitalize on opportunities.
Lab Corp Ready to Build: For Labcorp, 10 acquisitions have been made recently, and Labcorp CEO Adam Schechter said he aims to build on this momentum in 2025, focusing on oncology, neurology, autoimmune diseases, and women’s health, which are growing two to three times faster than routine testing.
OraSure Announces STI Products: CEO Carrie Eglinton Manner announced the firm’s progress on a 30-minute, instrument-free test for Chlamydia trachomatis and Neisseria gonorrhoeae, which is undergoing clinical trials and will be submitted to the FDA for over-the-counter approval by year-end. OraSure also plans to launch a proteomics product in 2025.
Quanterix Alzheimer Test: announced its entry into clinical diagnostics through its Lucent Diagnostics lab in Boston, which offers the LucentAD Complete test to assess amyloid brain pathology indicative of Alzheimer’s disease. The company has invested $20 million to fund studies, scale lab operations, and build a commercial team. Reimbursement for the test via the CMS Advanced Diagnostic Laboratory Tests pathway is anticipated by 2026.
In our previous article, we noted these developments at JPM. We include these here:
Roche Sees Mid to High Single-Digit Diagnostics Growth: -Roche primarily focused on its pharmaceutical portfolio during the presentation, highlighting a growing pipeline in hematology cell therapies and Alzheimer’s treatments, among others. Notably, the company reported no revenue drag from COVID-19 and a strong Q4 performance of +9% in combined pharmaceutical and diagnostics sales.
Looking ahead to 2030, Roche projected mid-to-high single-digit growth in its diagnostics business. This is higher than previous years and higher than where many firms (including Eye On IVD) have pegged IVD market growth (2-4%).
Also of note: While pharmaceutical growth will hinge on new product pipelines, diagnostics growth, the company says, will originate from on market, with new launches also a factor.
Check out EyeOnIVD.com for more news, analysis of that news, as well as IVD expert-written market research and business planning.
Increasing Local Competition in China: QuidelOrtho CEO Bill Blaser addressed challenges in the Chinese market, indicating that local competition from China-based IVD firms was a challenge and that the competition has increased in past years. This is significant, as Asia Pacific sales are over twenty percent of the company’s revenue. For 2024, the company forecasts revenues of $2.75–$2.8 billion, down from $3.0 billion in 2023. Last year’s revenues will be finalized in February. A “late ramp-up” in respiratory sales was cited as a primary factor in the decline. Despite this, Blaser emphasized QuidelOrtho’s strong position in both laboratory and point-of-care (POC) respiratory testing, supported by a robust installed base of 97,000 Sofia respiratory systems. While acknowledging the increasing competition in respiratory panel testing, Blaser stated that Sophia’s market position has not yet been significantly affected.
CEOs from Revvity and Waters echoed concerns about competition in the Chinese in vitro diagnostics (IVD) market, citing the proposed hospital stimulus as a potential positive for 2025 sales. bioMerieux warned that potential US tariffs will lead to China countermeasures – which could affect localized manufacturing, and the company will take appropriate steps as policies of both countries are defined.
No Letdown in Colon Cancer Screening Sales: Exact Sciences announced preliminary Q4 2024 revenues of $713 million, reflecting a 10% year-over-year increase. Screening revenues reached $553 million, a 14% rise compared to Q4 2023, while precision oncology revenue remained steady at $161 million.
Ready For Bird Flu, Should Pandemic Happen: Infectious disease diagnostic player bioMerieux noted that while bird flu has been present in just a few human cases, the company is ready. The company’s tests can today detect H1N1 [which can help triage patients for further specific tests] and the company “is looking into” how they can type the specific flu that causes bird flu, should the unfortunate circumstance of a pandemic occur.
New Lyme Test: Qiagen said it is on track to launch a Lyme test for its QuantiFERON platform in 2025, pending FDA clearance. The company highlighted the success of its QuantiFERON TB test and projected 50% revenue growth for the platform over the next four years. Additionally, Qiagen announced new companion diagnostics partnerships for its QIAstat-Dx system, including collaborations with Lilly (Alzheimer’s disease) and AstraZeneca (chronic diseases).
“As costs [on WGS] keep coming down, there just won’t be a reason to run targeted panels.”
WGS Over Targeted Panels: Tempus AI CEO Eric Lefkofsky highlighted the strategic importance of the company’s $600 million acquisition of Ambry Genetics, set to close on February 1, 2025. The deal positions Tempus to expand beyond oncology into pediatrics, rare diseases, immunology, women’s reproductive health, and cardiology while driving projected 2025 revenues to $1.23 billion growth of 25% for the combined companies. Ambry, a leader in genetic testing for hereditary diseases, specializes in hereditary cancer, cardiology, neurology, and rare diseases, making it a valuable addition to Tempus’ portfolio. This acquisition supports Tempus’ core focus on data and genomics, which performed on the plan in 2024 despite minor challenges in smaller segments and aligns with its long-term goal of transitioning to whole-genome sequencing.
“We’re excited to have whole-genome be the backbone of all of our assays,” Lefkofsky said, adding, “As costs keep coming down, there just won’t be a reason to run targeted panels.”
