New Ways. New Innovations. New Paths Towards Disease Management.

Cancer is Hard. Testing for it Shouldn’t Be.
Cepheid’s innovative oncology program offers a growing menu of molecular diagnostic tests that currently focus on cancers of the breast, bladder, and blood. Harnessing the power of quantitative PCR technology and the World's most popular sample-to-answer PCR testing system1, Cepheid oncology products provide on-site, on-demand, standardized, and reliable results.

Cepheid expanded its breast cancer diagnostics capabilities with the acquisition of OncoMark, a company that developed technology to estimate the likelihood of early-stage breast cancer recurrence after treatment.


Optimized to run on the Cepheid GeneXpert® systems, the technology uses a proprietary algorithm to produce a binary risk score (high risk vs low risk) to predict the likelihood of disease recurrence in the next 10 years.


Cepheid also continues to offer the Xpert® Breast Cancer STRAT4 biomarker test in countries accepting the CE-IVD mark.


To learn more, contact the Cepheid Medical and Scientific Affairs and Strategy team for Oncology at:

Xpert Breast Cancer STRAT-4 is not available in the US.

With Cepheid’s proven “lab in a cartridge™,” our tests give patients and their doctors peace of mind when it matters most. The pioneering mindset of our oncology team is bolstered by Cepheid’s strong molecular biology capabilities, extensive global infrastructure, and an unwavering commitment to scientific rigor.

Oncology Products

Xpert® BCR-ABL Ultra

Xpert® BCR-ABL Ultra

Sensitive and quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)
Xpert® Breast Cancer STRAT4

Xpert® Breast Cancer STRAT4

Standardized breast cancer ESR1/PGR/ERBB2/MKi67 mRNA biomarker assessment in less than two hours

Discover a Better Path with Xpert BCR-ABL Ultra2

The high sensitivity of the Cepheid BCR-ABL test, Xpert BCR-ABL Ultra*, allows for monitoring of disease even at low levels, thereby providing an essential aid for clinicians to manage their patients with CML, using IS-standardized molecular testing

Visit the Xpert BCR-ABL Product Page Visit the Xpert BCR-ABL Product Page
Xpert® BCR-ABL Ultra Resources:

Xpert® Bladder Cancer Detection3 & Xpert® Bladder Cancer Monitor3

Xpert Bladder Cancer Detection and Xpert Bladder Cancer Monitor* are two easy to use, non-invasive bladder cancer tests. Xpert Bladder Cancer Detection* is intended to detect the presence of bladder cancer in patients with hematuria. Xpert Bladder Cancer Monitor* is indicated as an aid to standard clinical evaluation in monitoring for bladder cancer recurrence in patients previously diagnosed with bladder cancer. Both tests measure five bladder cancer- specific biomarkers and require only a urine sample from the patient.

Visit the Xpert Bladder Cancer Monitor Product Page


Visit the Xpert Bladder Cancer Detection Product Page

Xpert Bladder Cancer Detection & Monitor Resources:

Xpert Breast Cancer STRAT4

Xpert Breast Cancer STRAT4* is an mRNA-based test that standardizes and simplifies the assessment of ESR1, PGR, ERBB2, and MKi67 breast cancer biomarkers. In less than 2 hours, the test provides objective and reproducible results that are well-correlated with central lab IHC/ISH methods. Clear and accurate results empower pathologists and oncologists.


Visit the Xpert Breast Cancer STRAT4 Product Page Visit the Xpert Breast Cancer STRAT4 Product Page

Xpert Breast Cancer STRAT4* Resources

In Here, We are Defining a New Era of Cancer Diagnostics

More than a decade ago, Cepheid set the standard for innovation in automated molecular diagnostics with the GeneXpert® System. The complicated process of nucleic acid extraction, amplification and detection is all carried out within each single use cartridge. By making complex technology easy to use, our GeneXpert® cartridge has become the symbol of the Molecular Revolution. Using advanced microfluidics, all aspects of the testing process are handled within the cartridge chambers, minimizing the risk of cross contamination. Each cartridge is standardized and comes with internal controls, making running extra standard curves obsolete. Our oncology tests quickly and accurately characterize multiple cancer markers using the same game changing system.


GeneXpert Resources

1. GeneXpert® systems - largest worldwide installed base for a single sample-to-answer PCR MDx testing system. Cepheid internal data, 2021
2. CE IVD and US-IVD. In Vitro Diagnostic Medical Device. Not available in all countries.
3. CE IVD. In Vitro Diagnostic Medical Device. Not available in all countries. Not available in the United States.