Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s broadest in vitro diagnostic menu

Rhea-AI Summary

Roche (OTCQX: RHHBY) announced on 11 December 2025 that it secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring, expanding its automated cobas Mass Spec IVD menu to 39 tests. The menu already covers therapeutic drug monitoring for immunosuppressants and antibiotics, steroid hormones and vitamin D metabolites, and aims to bring gold-standard mass spectrometry into routine labs via a fully automated workflow that reduces turnaround times and standardises results. Roche also reported a CLIA “moderate complexity” designation in the US for the first analyte, and said the solution is available in selected CE-mark markets and other countries including the UK, Canada and Japan. Roche plans further menu expansion and ongoing regulatory engagement.

Positive

• CE Mark for antibiotics drug monitoring reagent pack (11 Dec 2025)
• Automated IVD menu expanded to 39 tests
• CLIA "moderate complexity" designation for first US analyte
• Availability in selected CE-mark markets, UK, Canada, Japan

Negative

• Commercial availability limited to selected markets accepting CE mark
• Broader US and other regulatory clearances remain pending

News Market Reaction – RHHBY

-0.81%

1 alert

-0.81% News Effect

On the day this news was published, RHHBY declined 0.81%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

IVD menu size: 39 tests IVD targets covered: 39 targets CLIA year: 1988

3 metrics

IVD menu size 39 tests Automated mass spectrometry in vitro diagnostic menu

IVD targets covered 39 targets Most frequently tested targets on automated mass spectrometry platform

CLIA year 1988 Clinical Laboratory Improvement Amendments of 1988 (CLIA)

Market Reality Check

Price: $54.19 Vol: Volume 5,370,502 is 2.05x...

high vol

$54.19 Last Close

Volume Volume 5,370,502 is 2.05x the 20-day average of 2,619,116, indicating elevated interest pre-news. high

Technical Price 50.43 is trading above the 200-day MA at 41.66 and is near the 52-week high of 50.67.

Peers on Argus

Peers show mixed, mostly modest moves with ALPMY up 0.13%, DSNKY up 0.8%, OPHLY ...

Peers show mixed, mostly modest moves with ALPMY up 0.13%, DSNKY up 0.8%, OPHLY down 1.2%, and others flat, suggesting today’s 3.55% move in RHHBY is more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Diagnostic approval	Positive	-0.4%	CE Mark for cobas BV/CV PCR assay expanding sexual health testing.
Dec 09	Drug approval EU	Positive	-0.4%	EC approval for Gazyva/Gazyvaro in active lupus nephritis.
Dec 08	Clinical data update	Positive	-0.4%	Lunsumio data suggesting benefit in earlier lymphoma treatment lines.
Dec 08	Clinical data update	Positive	-0.4%	Genentech Lunsumio data with high complete response rates and durability.
Dec 08	Phase III follow-up	Positive	+0.8%	Three-year STARGLO data showing survival benefit for Columvi combo in DLBCL.

Pattern Detected

Recent positive regulatory and clinical news often saw slight negative price reactions, with only one of the last five events showing a clearly positive follow-through.

Recent Company History

Over the last few days, Roche announced several positive developments, including CE Mark approval for the cobas BV/CV PCR assay on Dec 09 2025, European Commission approval for Gazyva/Gazyvaro in lupus nephritis on Dec 09 2025, and strong Lunsumio and Columvi clinical data presented around Dec 08 2025. Despite these constructive updates, four of five prior news events saw mildly negative price reactions, indicating a pattern where strong scientific or regulatory milestones have not always translated into immediate share price strength.

Market Pulse Summary

This announcement highlights the expansion of Roche’s automated mass spectrometry in vitro diagnosti...

Analysis

This announcement highlights the expansion of Roche’s automated mass spectrometry in vitro diagnostic menu to 39 tests, including antibiotic drug monitoring, aiming to bring gold-standard sensitivity and specificity into routine labs. Context from recent news shows a series of constructive regulatory and clinical milestones across diagnostics and oncology. Investors may watch uptake of the cobas Mass Spec solution, further assay additions, and additional regulatory designations such as CLIA categorizations to gauge the platform’s broader impact.

Key Terms

mass spectrometry, in vitro diagnostic, therapeutic drug monitoring, antimicrobial resistance, +3 more

7 terms

mass spectrometry technical

"Roche’s automated mass spectrometry platform now offers the industry’s broadest..."

Mass spectrometry is a laboratory technique that identifies and measures chemicals by giving molecules an electrical charge and sorting them by how fast they move, like weighing and separating coins to see which kinds are present. For investors, its results are evidence used in drug development, quality control, food and environmental testing, and diagnostics, so clear mass-spec data can affect regulatory approval, product reliability, costs and market confidence.

in vitro diagnostic medical

"offers the industry’s broadest in vitro diagnostic menu with 39 tests..."

In vitro diagnostics are tests, instruments and kits used to analyze samples taken from the body—such as blood, urine or swabs—outside the body (in a lab or cartridge) to detect disease, infections, genetic traits or other biological signs. Investors care because these products generate sales, recurring revenue from consumable test kits, and value that hinges on test accuracy, regulatory approvals and reimbursement policies; like a home pregnancy test but for many medical conditions.

therapeutic drug monitoring medical

"tests for therapeutic drug monitoring for immunosuppressants and antibiotics..."

Therapeutic drug monitoring is the routine measurement of a medicine’s level in a patient’s blood to make sure the dose is high enough to work but low enough to avoid harmful side effects. Investors should care because monitoring can shape how widely a drug is used, influence the need for accompanying tests or devices, affect regulatory approval or labeling, and alter long-term sales and liability risks—like using a thermostat to keep a room at the right temperature for reliable performance.

antimicrobial resistance medical

"a vital step in combating the major global healthcare challenge of antimicrobial resistance."

Antimicrobial resistance is when microbes such as bacteria, viruses or fungi evolve so that medicines meant to kill them no longer work — like a lock changing so the old key no longer fits. For investors, this increases demand and cost for new treatments, prolongs hospital stays, prompts tougher regulation and can shrink sales of once-effective drugs, affecting pharmaceutical revenues, R&D spending and broader healthcare risk.

Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulatory

"categorisation under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)..."

A federal program that sets quality and certification rules for U.S. clinical laboratories that perform tests on human specimens, ensuring accuracy, reliability and proper personnel and equipment—think of it as a safety inspection and licensing system for medical testing labs. For investors, CLIA status signals whether a lab’s test results meet regulatory standards, which affects a lab’s ability to bill insurers, sell diagnostic services, expand testing, and avoid fines or shutdowns.

CE Mark regulatory

"secured CE Mark approval for its mass spectrometry reagent pack..."

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

analyte medical

"categorisation ... of the first analyte in the US."

An analyte is a specific substance or chemical component measured in a laboratory test—such as a protein, molecule, ion, or biomarker—whose presence or amount gives information about a sample. For investors, analytes matter because tests and devices that detect or quantify them drive product demand, regulatory approval and recurring revenue; like a car’s fuel gauge showing fuel level, analyte measurements indicate health or disease status that affects market value.

AI-generated analysis. Not financial advice.

• With this approval, Roche’s automated mass spectrometry platform now offers the industry’s broadest in vitro diagnostic menu with 39 tests, including tests for therapeutic drug monitoring for immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites.
• The comprehensive menu brings the sensitivity and specificity of gold-standard testing into routine labs for a wide range of the most frequently tested targets.
• The fully automated solution replaces labour-intensive manual workflows, reducing turnaround times and supporting faster, standardised, high-quality care.

Basel, 11 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring. This establishes Roche's in-vitro diagnostics (IVD) menu as the broadest available for any automated mass spectrometry platform, including already 39 of the most frequently tested targets.

“When patients get results sooner, we increase the likelihood that they will get the right treatment,” said Matt Sause, CEO of Roche Diagnostics. “With a comprehensive menu for automated mass spectrometry, we are giving clinicians and laboratories the tools to make faster, more precise diagnoses, reducing the time from sample to result. This approach also allows clinicians to better monitor the effectiveness of drug therapies and to optimise antibiotic use, a vital step in combating the major global healthcare challenge of antimicrobial resistance."

The cobas® Mass Spec solution Ionify® reagent portfolio includes tests for therapeutic drug monitoring for immunosuppressants and antibiotics, along with steroid hormones and vitamin D metabolites. These tests will enable laboratories to transition from labour-intensive and manual operation to a fully automated, standardised, easy to use solution.^1-3 Roche remains committed to expanding this menu with additional assays in the coming years, including the first panel in drugs of abuse testing and further expanding the menu of therapeutic drug monitoring parameters.

The cobas Mass Spec solution is currently available in selected markets accepting the CE mark, as well as other markets including the United Kingdom, Canada and Japan. In parallel, Roche achieved "moderate complexity" categorisation under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) of the first analyte in the US. As the first mass spectrometry assay to receive this designation, it marks a significant step toward broadening clinical utility across routine laboratories by eliminating the need for specialists to run the assay.  Roche is continuously working with regulatory authorities around the world to further expand system and assay availability.

About the cobas Mass Spec solution
The high specificity, sensitivity and accuracy of mass spectrometry is considered the diagnostic ‘gold standard’ for various clinical situations, for example, measurements of steroid hormones in endocrinology, vitamin D testing, the monitoring of immunosuppressants and therapeutic drugs. The cobas Mass Spec solution combines the unmatched sensitivity and specificity of mass spectrometry with a fully automated, integrated, and standardised workflow, making this traditionally complex analytical method accessible to routine laboratories.

As part of the trusted cobas ecosystem, the cobas Mass Spec solution can integrate seamlessly with Roche’s clinical chemistry, immunochemistry, and laboratory IT systems, enabling laboratories to fully streamline workflows.

In July 2025, the cobas Mass Spec solution was awarded the Best New Clinical Diagnostics Instrumentation of 2024 in the Scientists' Choice Awards® 2025.  The Awards were first introduced in 2007 by SelectScience, with nominations collected and assessed by their editors and the most popular nominations put to vote among their readership of scientists.

For more information about the cobas Mass Spec, please visit diagnostics.roche.com/MassSpec

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Grebe SK, Singh RJ. LC-MS/MS in the Clinical Laboratory - Where to From Here? Clin Biochem Rev. 2011;32(1):5-31.
[2] Hristova J & Svinarov D. Enhancing precision medicine through clinical mass spectrometry platform. Biotechnology & Biotechnological Equipment. 2022;36(1):107-117.
[3] Ketha SS, Singh RJ, Ketha H. Role of Mass Spectrometry in Clinical Endocrinology. Endocrinol Metab Clin North Am. 2017;46(3):593-613.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche Investor Relations

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Investor Relations North America

Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

Attachment

• Media Investor Release Mass Spec iPacks English

FAQ

What did Roche (RHHBY) announce on December 11, 2025 about mass spectrometry?

Roche announced CE Mark approval for its antibiotics drug monitoring reagent pack, expanding its automated mass spec IVD menu to 39 tests.

How does the new Roche cobas Mass Spec menu affect laboratory workflows for RHHBY customers?

The fully automated solution is designed to replace manual workflows, reducing turnaround times and standardising results for routine labs.

Is Roche's mass spectrometry solution available in the US for routine labs (RHHBY)?

Roche received a CLIA "moderate complexity" designation for the first US analyte, but broader US regulatory availability is still subject to further approvals.

Which test categories are included in Roche's 39-test automated mass spec menu (RHHBY)?

The menu includes therapeutic drug monitoring for immunosuppressants and antibiotics, steroid hormones, and vitamin D metabolites.

Where is Roche's cobas Mass Spec solution currently available for RHHBY investors?

The solution is available in selected markets accepting the CE mark, and in other markets including the UK, Canada and Japan.

Will Roche expand the cobas Mass Spec test menu further (RHHBY)?

Roche said it plans to expand the menu with additional assays, including drugs of abuse testing and more therapeutic drug monitoring parameters.