Cepheid

Sensitive and quantitative monitoring of BCR-ABL p190 and ABL mRNA in patients with chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL)

Automated test for quantifying the amount of mutant NPM1 mRNA transcripts (types A, B, and D in exon 12) as a ratio of NPM1 Mutation/ABL1 with high sensitivity

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

Qualitative monitoring for recurrence in patients previously diagnosed with bladder cancer in around 90 minutes

A qualitative in vitro diagnostic test for the detection of DNA from Group B Streptococcus (GBS) using a dual vaginal/rectal swab specimen collected from pregnant females during antepartum or intrapartum. Provides results in 30–42 minutes to aid in diagnosis of GBS colonization and identify candidates for antibiotic prophylaxis.

A multiplexed real-time RT-PCR test intended for the simultaneous, qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA in nasopharyngeal swab, nasal swab or nasal wash/aspirate specimens from individuals suspected of respiratory viral infection.

A molecular test kit for simultaneous detection of SARS-CoV-2, Influenza A/B, and RSV using the Xpert Xpress system.

FDA cleared multiplex respiratory PCR assay for simultaneous detection of SARS-CoV-2, Influenza A/B, and RSV.

A multiplex respiratory PCR assay for simultaneous detection of SARS-CoV-2, Influenza A/B, and RSV.

A molecular test kit for rapid detection of influenza A, influenza B, and respiratory syncytial virus (RSV) using the GeneXpert system.

A rapid, real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

A molecular test kit for rapid detection of SARS-CoV-2, designed for use on the GeneXpert system.

CE-IVD marked molecular test kit for detection of Influenza A/B and RSV.

FDA cleared molecular test kit for detection of SARS-CoV-2.

A molecular test kit for simultaneous detection of Influenza A/B and RSV.

A molecular test kit for rapid detection of SARS-CoV-2.

CE-IVD marked molecular test kit for detection of SARS-CoV-2.

Molecular test kit for detection of Influenza A and B viruses.

An automated qualitative in vitro diagnostic test performed on the GeneXpert® system for detection of DNA targets from anaerobic bacteria associated with bacterial vaginosis, Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis.

A compact molecular testing system with four active modules, designed for fast, actionable data with many tests returning in less than 60 minutes. It features less than one minute hands-on time, can run up to four tests at one time, requires no specialized training or daily maintenance, and supports bi-directional interface with laboratory information systems.

A market-leading sample-to-answer PCR diagnostic testing system with the largest global installed base, operating in over 180 countries. It is an easy-to-use, random-access real-time PCR platform that enables on-demand testing with automated nucleic acid extraction, PCR amplification, and detection using single-use test cartridges.

A compact molecular testing system with two active modules, designed for fast, actionable data with many tests returning in less than 60 minutes. It features less than one minute hands-on time, can run up to four tests at one time, requires no specialized training or daily maintenance, and supports bi-directional interface with laboratory information systems.

2-module system instrument for running Xpert Xpress tests, compact and scalable.

4-module system instrument for running Xpert Xpress tests, compact and scalable.

A system enabling a comprehensive menu of tests to be run on a single system by a single operator in a moderately complex, real-time environment.

Now enabling multiplexing using 10-color technology

A high-throughput molecular diagnostic system with 10-color multiplex technology, capable of running a broad menu of Xpert tests with true random access and automated sample processing.

A high-throughput molecular diagnostic system with 10-color multiplex technology, capable of running a broad menu of Xpert tests with true random access and automated sample processing.

Flexible PCR at Scale: On-demand, High-throughput System for Molecular Diagnostic Testing

Detection and differentiation of Clostridioides difficile and the epidemic presumptive 027 strain, with a callout for binary toxin, in around 43 minutes from unformed stool specimens.

Detects methicillin-resistant Staphylococcus aureus (MRSA) directly from nasal swabs in around 70 minutes.

Detects MRSA and S. aureus skin and soft tissue infections in about an hour.

Detects MRSA and methicillin-susceptible Staphylococcus aureus (MSSA) in positive blood cultures in about an hour.

A multiplex test detecting mutations associated with resistance to multiple tuberculosis drugs, designed to guide treatment of drug-resistant tuberculosis, especially in developing countries.

An updated molecular test with faster results and improved design for tuberculosis detection and rifampin resistance, building on the original Xpert MTB/RIF test.

A multiplex molecular test designed to detect influenza A, influenza B, RSV, and SARS-CoV-2 with multiple gene targets to handle viral genetic drift and mutations effectively.

A multiplex molecular test launched in 2014 for detecting influenza A (including H5N1 and H3N2 variants), influenza B, and respiratory syncytial virus (RSV) A and B, designed as a pandemic-ready flu test with extended coverage and available in U.S. and European markets.

Cepheid's patented, single-use test cartridge that contains nucleic acid extraction, amplification, and detection all self-contained, enabling sample-to-answer PCR testing on the GeneXpert system.

GX-IV - 4 module instrument with touchscreen for PCR testing.

GX-XVI - 16 module instrument with touchscreen for high-throughput PCR testing.

Provides highly accurate detection of Norovirus with results in as little as one hour.

A qualitative and on-demand test for the detection and differentiation of carbapenem resistance of KPC, NDM, VIM, OXA-48, and IMP in 50 minutes.

The Xpert HCV test, performed on the GeneXpert® Xpress system, is an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of hepatitis C virus (HCV) RNA in human fingerstick K2EDTA whole blood from adult individuals at risk and/or with signs and symptoms of HCV infection.

A molecular test with FDA Emergency Use Authorization and WHO eligibility listing for Ebola virus detection, deployed in West Africa and other affected countries to aid outbreak containment.

Supports pre-surgical testing of S. aureus and MRSA in about an hour.

An in vitro nucleic acid amplification test designed for the quantitation of Hepatitis B Virus DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals, providing results in less than one hour.

Detection of the vanA gene sequence associated with vancomycin-resistant enterococci (VRE) in about 48 minutes.

ResistancePlus® MG FleXible detects both M. genitalium and macrolide resistance in approximately 2 hours, offering a streamlined molecular testing solution when used with GeneXpert® Systems. It is validated on a wide range of specimen types and collection devices, including urine and various swabs.

A syndromic test detecting multiple causes of vaginitis including bacterial vaginosis, Candida group, C. glabrata/C. krusei, and Trichomonas vaginalis. It is the first CLIA waived nucleic acid amplification test for vaginitis in the U.S.

A cartridge-based test developed in partnership with Northrop Grumman to detect anthrax spores, used by the United States Postal Service as part of its Biohazard Detection System.

A qualitative real-time PCR test that provides accurate detection and differentiation of SARS-CoV-2, Flu A, Flu B, and RSV with results for SARS-CoV-2 in as little as 25 minutes.