Multiplex with Meaning: Cepheid’s Smart Approach to Molecular Diagnostic Testing

In an era where speed, accuracy, and clinical relevance are paramount, multiplex testing has emerged as a transformative force in molecular diagnostics. At Cepheid, we’ve long been committed to delivering rapid, actionable results that empower clinicians and improve patient outcomes. Our leadership in multiplex molecular testing reflects both our legacy of innovation and our vision for the future of diagnostics.

Our Editorial Team chatted with Dr. David Persing, Cepheid’s former Chief Medical and Technology Officer and current Senior Advisor, about multiplex panels and the near future.

What Are Multiplex and Syndromic Panels?
A multiplex panel is a molecular test that detects multiple genetic targets (pathogens, antimicrobial resistance genes, or other biomarkers) simultaneously from a single patient sample. Syndromic panels refer to multiplex tests that simultaneously detect multiple pathogens associated with overlapping symptoms,^1.2 though the terms multiplex and syndromic are often used interchangeably.³

Why Are Multiplex Panels Important?
By providing multiple results in a single test, multiplex testing has the potential to improve operational efficiency, streamline diagnosis, and improve the quality of care.^1.4 In clinical conditions for which distinct infectious agents can cause overlapping symptoms, such as respiratory infections, gastrointestinal illnesses, or sexually transmitted infections, multiplex testing can reduce diagnostic uncertainty, enable targeted antiviral or antibiotic therapies, and support antimicrobial stewardship.¹

But not all panels are created equal. The industry has seen a proliferation of larger panels,⁵ some of which may include pathogens with uncertain clinical relevance.⁶ This has led to concerns about over-testing, cost, and diagnostic ambiguity^(5-7) — highlighting the need for diagnostic stewardship^(8.9) and smart approaches to test design.

What is Cepheid’s History in Multiplex Testing?
Cepheid has a strong foundation in multiplex and syndromic testing and has demonstrated leadership in this space with several key products:

• Multi-target test design enabled by multiplex technology is built into ‘targeted’ tests such as Xpert Xpress CoV-2 plus, which has three gene targets for robust detection of a single pathogen—SARS-CoV-2.

• Xpert® Xpress CoV-2/Flu/RSV plus: A syndromic respiratory test that differentiates between SARS-CoV-2, influenza A/B, and RSV—for addressing co-circulating viruses that cause overlapping respiratory symptoms. This test actually amplifies 10 distinct targets to detect four viruses. Here again, target redundancy is built into the test to accommodate potential genetic drift that is common among RNA viruses.

• Xpert® Xpress MVP (Multiplex Vaginal Panel): A syndromic test that detects multiple causes of vaginitis, including four separate callouts: bacterial vaginosis (with targets for three vaginosis-associated anaerobic bacteria); Candida group (consisting of C. albicans, C. tropicalis, C. parapsilosis, and C. dubliniensis reported as a group); C. glabrata/C. krusei; and Trichomonas vaginalis. This was the first CLIA waived nucleic acid amplification test for vaginitis in the U.S.¹⁰

• Xpert® Carba-R: A multiplex test that detects and differentiates gene sequences of the “big 5” carbapenemases, KPC, NDM, VIM, IMP, and OXA-48 from carbapenemase-producing Enterobacterales (CPE). These organisms have emerged as a global threat due to extensive antibiotic resistance.¹¹

• Xpert® MTB/XDR*: A multiplex test that detects mutations associated with resistance to multiple tuberculosis drugs, responding to a critical need for diagnostics to guide treatment of drug-resistant tuberculosis, particularly in developing countries.^12,13

Is Cepheid Intensifying its Focus on Multiplex Testing?
The timing of our anticipated expansion into syndromic panels^† is no coincidence. The global healthcare landscape is evolving rapidly, with increasing demand for diagnostic tools that are not only fast and accurate but also clinically meaningful.

Cepheid’s strategy is driven by a clear need: clinicians require tools that deliver actionable insights, not just data. Our tests are designed to meet this need, aligning with best practices and regulatory expectations while maintaining the simplicity and reliability our customers expect.

What is Cepheid’s Approach?
Our approach to diagnostic testing remains steadfast. It is built on four pillars:

1.     Simplicity: Our Lab in a Cartridge™ technology automates the entire PCR process—nucleic acid extraction, amplification, and detection—within a self-contained cartridge. This innovation makes molecular testing fast and more accessible.

2.     Reliable answers: PCR technology is known for its high accuracy, but healthcare providers need more than a result. Which is why our approach to test design is grounded in quality and clinical relevance. We prioritize targets relevant to patient management, avoiding the inclusion of organisms with unclear clinical significance. And by integrating a suite of tests that allow clinicians to choose the right test for the right patient at the right time, we aim to promote diagnostic stewardship and optimized care.

3.     Broad menu: We have demonstrated clinical expertise across multiple disease areas, including respiratory infections, hospital-acquired infections, blood virology, women’s and sexual health, tuberculosis and emerging infectious diseases, and oncology and human genetics.

4.     Access: Cepheid’s GeneXpert® family of systems allows institutions of varying sizes—from small clinics to large hospitals—to perform molecular testing with minimal infrastructure. Our partnerships with governments, non-profits, and other organizations help us realize our commitment to expanding access to diagnostics worldwide.

What Does the Future Hold?
Cepheid continues to innovate and expand our test menu, focusing on fast, accurate, and accessible diagnostics. Looking ahead, we envision a multiplex test portfolio that spans multiple disease categories, complemented by targeted and low-plex testing to provide a flexible and versatile portfolio and enable diagnostic stewardship.

As we expand, we remain committed to our legacy of simplifying complex diagnostics and delivering answers that matter for our customers and the patients they serve.

Conclusion

By combining our heritage of innovation with a forward-looking approach to clinical utility and diagnostic stewardship, we are helping shape the future of diagnostics. And as always, we’re doing it with one goal in mind: better outcomes for patients, everywhere.