How are IVD stocks doing in the general market fall? About that huge flu season. A mid-size player reports, which (can be) a measure of the growthiness of the market. And Roche adheres its blood test to its IT-IVD product to aid interpreting results.
DiaSorin Reports – Overall Growth, China VP Concerns, Not Tariff Concerns
Another IVD company has released results worth noting. This from a mid-size grower with a competitive molecular system. DiaSorin reported Q1 2025 revenues up 8% year over year, 10% when excluding COVID-19. Little tariff impact is projected by the company.
But China volume buying was hurtful to revs, making this company one of several IVDs to point this out. Sales in other regions declined 1%, mainly due to reduced revenues in China tied to that country’s centralized volume-based procurement program.
On tariffs – CFO Piergiorgio Pedron said, “We expect the tariffs will have an impact of less than €5 million EBITDA for the full year,” and said most U.S.-made products sent to China had “cleared customs without added tariffs.”
We note: That still means there could be future impacts when these inventories deplete, unless Chinese manufacturing can make up (the company did secure approval to manufacture a large system in the country).
China volume buying was hurtful to revs making this company one of several IVDs to point this out.
Immunodiagnostics revenues (excluding COVID-19) rose 9%, partially offset by weaker results in China. Molecular diagnostics (excluding COVID-19) grew 10%
A Mix: IVD Stocks
Amid the general market tumult, some in vitro diagnostic-related stocks have held their own, but many – particularly those tied to life sciences, have taken a hit greater than the drop in the Dow since the announcement of U.S. tariffs.
We don’t talk much about stock prices because most IVD players have multi-faceted companies. The number one and number two companies, obviously are heavily invested in pharmaceuticals and Abbott is a cardiac device player. Yet it’s worth visiting the topic, as stock power could affect what moves companies can make in the market place.
UP –
- Abbott Laboratories (NYSE: ABT): The stock climbed steadily, rising from around $114 in January to approximately $132 by early May 2025—an increase of about 15%.
- Roche Holding AG (SWX: ROG): Shares moved upward modestly, gaining 4.6% over the same period, from CHF 260 to CHF 272, reflecting relative stability.
- bioMérieux S.A. (EPA: BIM): Shares advanced from €106.60 to €118.20, delivering a gain of about 11% since the beginning of the year.
DOWN –
- Qiagen N.V. (NYSE: QGEN): The stock edged lower, declining around 6.5% from $45.96 in January to $42.98 in May 2025.
- Bio-Rad Laboratories Inc. (NYSE: BIO): The company saw a sharp downturn, with its stock falling approximately 32%, from \$350 in January to \$239 in May. (This also comes as BD announced the split of its IVD and life sci business).
- Becton, Dickinson and Company (NYSE: BDX): BD’s stock experienced one of the steepest drops—falling approximately 33% over the five-month period, from $247.60 to $166.72.
- Danaher Corporation (NYSE: DHR): Shares contracted by roughly 11.4%, slipping from $222.74 in January to $197.40 by May.
You are seeing a pattern of life-sci companies suffering b/c of real and possible new cuts to research. But, we add a clinical-focused company:
- QuidelOrtho Corporation (NASDAQ: QDEL): The company faced the most pronounced decline, with its stock losing 37%—dropping from $43.46 at the end of January to $27.37 by early May.
2025 Influenza Season Now Compared to 2009
The 2024–2025 flu season has emerged as one of the most severe in recent memory, drawing comparisons to the 2008–2009 season. Although the 2008–2009 outbreak was marked by the emergence of a novel pandemic H1N1 strain, this current season has been driven by widespread circulation of both Type A H1N1 and H3N2 viruses—compounded by reduced vaccination rates, especially among children.
According to the CDC, as of early 2025, there have been at least flu-related illnesses, 580,000 hospitalizations, and 25,000 deaths, including 216 pediatric death – a record for a non-pandemic year. California alone reported over 900 flu-related deaths , one of the highest regional tolls in decades.
The 2008–2009 flu season was initially moderate until the emergence of the novel H1N1 strain in April 2009. This virus caused a pandemic, eventually infecting around 60 million people in the U.S., with a hospitalization rate of 53.1 per 100,000 population , particularly affecting children and younger adults.
Which companies saw Flu Testing Revenue impact?
- Sekisui Diagnostics – OSOM Influenza A\&B Test
- LumiraDx – LumiraDx Flu A/B Test (point-of-care)
- Hologic – Panther Fusion Flu A/B/RSV assay (high-throughput molecular platform)
- Ellume – Ellume Flu Test (Bluetooth-enabled home flu testing, U.S. market under EUA)
- CorDx – Influenza A/B Test Cassette (lateral flow tests for professional and OTC use)
- Roche Diagnostics – cobas Liat, Elecsys Flu A/B, multiplex respiratory panels
- Abbott – ID NOW Influenza A & B, BinaxNOW Flu
- QuidelOrtho – Sofia Influenza A+B FIA, QuickVue Flu tests
- BD (Becton, Dickinson and Company) – Veritor System for Rapid Detection of Flu A+B
- Thermo Fisher Scientific – TaqPath respiratory virus panels (includes flu)
- bioMérieux – BioFire FilmArray Respiratory Panels
- SD Biosensor STANDARD Q Influenza A/B test (rapid test)
Europe’s Turn: German Lab Groups Push to Ease IVDR Rules on LDTs
A story in 360 DX (https://www.360dx.com/regulatory-news-fda-approvals/german-associations-call-alterations-ivdr-support-continued-use-ldts) notes that – Following U.S. legal pushback on lab-developed test (LDT) oversight, German medical groups are urging changes to the EU’s In Vitro Diagnostic Regulation (IVDR). They argue that requiring CE-marked tests over in-house devices (IHDs) threatens access to diagnostics for rare diseases and slows innovation.
In a joint statement, the following organizations called for an exemption to the IVDR’s “equivalency clause” and criticized excessive documentation burdens:
Professional Association of German Human Geneticists (BVDH)
Professional Association of German Pathologists (BDP)
German Society for Pathology (DGP)
German Society for Human Genetics (GFH)
Professional Association of German Laboratory Doctors (BDL)
Accredited Laboratories in Medicine (ALM)
Association of Physicians for Microbiology, Virology and Infection Epidemiology (BÄMI)
German Association of Medical Specialists (SpiFa)
They noted that German labs already comply with strict standards under RiliBÄK and ISO 15189, and additional IVDR bureaucracy may jeopardize critical in-house testing.
Roche Launches Chest Pain Triage Algorithm Integrated with Cardiac Troponin Testing
Chest pain is a top 10 reason for an ER visit. Yet most chest pain is not heart attack. Those two facts scream for a tool to assist providers not only to diagnose correctly, but fast.
Roche has released a new digital tool aimed at improving emergency department triage for patients presenting with chest pain. The Chest Pain Triage algorithm, part of the company’s navifyⓇ Algorithm Suite, is designed to work alongside Roche’s high-sensitivity cardiac troponin T (cTnT) assay, a widely used biomarker test for detecting heart injury.
The algorithm incorporates time-sensitive protocols from the European Society of Cardiology (ESC) and uses cTnT assay results to assign patients to one of three pathways: “Rule-In,” “Rule-Out,” or “Observe” for potential Acute Coronary Syndrome (ACS). It is intended to reduce diagnostic uncertainty and improve efficiency in emergency settings by integrating directly with existing laboratory instrumentation and workflows.
The tool operates within Roche’s broader diagnostic infrastructure, including its analyzers and lab middleware, allowing laboratories to implement the algorithm without significant changes to their current systems. Roche reports that the combined use of the troponin assay and the algorithm may reduce emergency department stay times and avoid unnecessary admissions.
The algorithm is deployed through navify, Roche’s cloud-based digital health platform. navify provides clinical decision support by integrating diagnostics, algorithms, and healthcare data, and is compatible with Electronic Health Records (EHR) and Laboratory Information Systems (LIS).
