Immediate Flu results you can trust.
Laboratory diagnosis of pandemic (H1N1) 2009 virus has important implications for case management, such as infection control procedures, consideration of antiviral treatment options and avoiding the inappropriate use of antibiotics. Reverse transcriptase polymerase chain reaction (RT-PCR) will provide the most timely and sensitive detection of the infection. Clinical Management of Human Infection with Pandemic (H1N1) 2009: Revised Guidance - World Health Organization. Runs On : GeneXpert® System

The Need
The appearance and worldwide spread of 2009 H1N1 virus highlighted the need for healthcare institutions to reassess their testing programs. Rapid determination of Flu A and Flu B infection and identification of 2009 H1N1 can assist hospitals in better managing patients presenting with Influenza Like Illness (ILI).

A study published by the CDC in 2009 found that Current available rapid diagnostic tests exhibit limited sensitivity (10-70%) compared to RT-PCR for detection of 2009 H1N1, and are unable to discriminate influenza strain type.
Source : MMWR Weekly August 7, 2009 / 58(30); 826-829

The Solution
Rapid and accurate determination of Flu A and Flu B infection and identification of 2009 H1N1 strain type maximizes medical decision making - enabling testing to take place in real time during a patient presentation:

• Rapid identification of infection improves isolation and infection control measures and enhances patient flow and bed utilization.
• Accurate detection and differentiation of Flu A from Flu B infection and simultaneous identification of 2009 H1N1 flu strain reduces the need for additional or confirmatory testing.
• Less than two minutes hands-on time improves lab workflow efficiencies.
• Innovative single-use cartridge design enables on-demand STAT testing.
• Accepts Nasal Aspirate/Washes (NA/W) or Nasopharyngeal (NP) Swab to accommodate wide range of specimen types.

A powerful solution is now available for fast detection of Enteroviral meningitis - Cepheid's Xpert® EV. Designed to significantly enhance patient management, results from Xpert EV (available in about 2.5 hours) provide critical answers when they matter most. Today, waiting 2-15 days for culture results is no longer your only option. Coupled with the simplicity of Cepheid's GeneXpert® System, on-demand EV results can be available 24 hours a day, 365 days a year.
Runs On : GeneXpert System

Problem
Enteroviruses are the most common cause of meningitis in the US, resulting in an estimated 30,000 to 50,000 hospitalizations per year. Most cases of meningitis are caused by infectious agents, primarily bacteria and viruses. Bacterial meningitis is generally more severe and potentially more life threatening. The viral form usually self-resolves within 7-10 days and accounts for the majority of cases overall. Currently, when a patient presents with meningitis-like symptoms, a spinal tap is performed and the cerebral spinal fluid is cultured to determine the etiology. Patients are often treated empirically with antibiotics, and possibly antiviral drugs, until bacteria and viral cultures become available in two to three days. Isolation of EV, from CSF, requires 2-3 days or longer - and results are rarely rapid enough to affect patient management.

Solution
Introducing Cepheid's Xpert EV, the only molecular in vitro diagnostic test that delivers results in about 2.5 hours. When Xpert EV results are used in conjunction with standard laboratory results (for CSF Gram stain, CSF bacterial culture, CSF glucose, CSF-blood glucose ratio, CSF total protein concentration, and CSG leukocyte count) physicians can now confidently identify patients with EV and manage appropriately instead of just treating symptoms.

Impact
The impact of Cepheid's Xpert EV is substantial: Identifying those patients with Enterovirus and helping to rule out bacterial meningitis quickly allows for appropriate management of patients. Timely answers provides assurance to patients and their families which helps to reduce anxiety.

"For the first time, we are able to offer highly accurate results we can act upon while the patient is still in the clinic. This may have far-reaching effects, such as improving contact tracing and reducing ongoing spread of infection in the community, as well as being popular with our patients. I am impressed with the highly accurate results obtained with Xpert® CT/NG. The simplicity of sample prep and the easy-to-use format of the GeneXpert® cartridge provide same-day results in around 90 minutes." - Dr. Simon Goldenberg, Consultant Microbiologist, Guy's & St. Thomas' NHS Foundation Trust, London
Runs On : GeneXpert® System

The Need
According to the World Health Organization (2001), an estimated 92 million chlamydia infections occurred worldwide, affecting more than 50 million women and 42 million men. These numbers are followed closely by a staggering 62 million cases of gonorrhoeae, ranging in numbers from 1 to 3.5 million in West and Eastern Europe, to an alarming 27 million in South and Southeast Asia.

Young people under 25 years of age carry the burden of up to 50% of CT/NG infections in a population. Infections left undiagnosed and treated impact patient health, fertility, and increase vulnerability to other opportunistic infections such as HPV and HIV.

N. gonorrhoeae drug resisitance has evolved in the last 100 years from increased penicillin resistance to fluroquinalone resistance, making the need to test and effectively treat infections a critical concern to public health. Since in many countries, incidence or prevalence data are not complete enough to provide an accurate picture of disease distribution, the significant proportion of asymptomatic and undiagnosed infections limits healthcare providers the ability to contain the spread of the disease.

The Solution : Xpert® CT/NG

• Simultaneous detection of both CT and a dual target NG.
• Sample adequacy and Process controls for every sample tested.
• Results in 90 minutes; requires no instrumentation other than the GeneXpert® System.
• On-demand results enable physicians to consult and treat patients with the appropriate medications.

Untreated Chlamydia trachomatis infections can lead to serious complications including pelvic inflammatory disease (PID), where the majority of symptoms are too mild or nonspecific women to seek medical treatment. Of those women with PID, 20% will become infertile; 18% will experience debilitating, chronic pelvic pain; and 9% will have a life-threatening tubal pregnancy. (CDC MMWR, Vol. 51 / No. RR-15)
Runs On : GeneXpert® System

The Need
According to the World Health Organization (2001), an estimated 92 million chlamydia infections occurred worldwide, affecting more than 50 million women and 42 million men.
Young people under 25 years of age carry the burden of up to 50% of CT/NG infections in a population. Infections left undiagnosed and treated impact patient health, fertility, and increase vulnerability to other opportunistic infections such as HPV and HIV.

The Solution : Xpert® CT

• Specific detection of Chlamydia trachomatis (CT).
• Easy to use for near patient testing clinical environments.
• Sample adequacy and Process controls for every sample tested.
• Results in 90 minutes; requires no instrumentation other than the GeneXpert® System.
• On-demand results enable physicians to consult and treat patients with the appropriate medications.

* Not available in all regions.

Now rapid intrapartum or antepartum GBS results can be available in as quickly as 30+ minutes (for positive samples) versus 2 days. This revolutionary in vitro diagnostic test is the first and only molecular test designed to be run in the clinical lab and near-patient by non-laboratory professionals such as labor and delivery nurses - 24 hours a day, 365 days a year. Xpert® GBS is the only in vitro diagnostic test to fully meet the CDC criteria for rapid intrapartum GBS testing. Cepheid's Xpert GBS assay empowers clinicians to make appropriate patient management decisions at the time of delivery.
Runs On : GeneXpert® System

Problem
In Europe and the United States, Group B streptococcus (GBS) is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia and meningitis. Transmission of GBS occurs from GBS colonized women to their babies during childbirth.
The current standard of care for preventing neonatal GBS disease calls for the use of culture in screening expectant mothers at 35-37 weeks of gestation. Although adequate for obtaining antepartum GBS results, this is an unacceptable solution for providing timely results for intrapartum patients who's GBS status is unknown when they present in the hospital to deliver. Current rapid GBS testing methods provide an underwhelming sensitivity level of less than 65%.

Solution
To better guide proper patient management, intrapartum GBS status must be determined quickly. Introducing Cepheid's Xpert GBS, the only in vitro diagnostic test to fully meet CDC criteria for rapid intrapartum GBS testing. With results in 30+ minutes for positive and 52 minutes for negative, Xpert GBS delivers 91.9% sensitivity and 95.6% specificity for intrapartum testing.

Comparison of Xpert GBS assay and the CDC culture technique for intrapartum testing :

Simple
The Xpert GBS test, performed on Cepheid's GeneXpert System®, delivers unprecedented ease-of-use. It is the only molecular in vitro diagnostic GBS test designed for use in the clinical lab and by non-laboratory professionals such as labor and delivery nurses - a first for a molecular test. Now Xpert GBS tests can be run as needed - 24 hours a day, 365 days a year. Users simply perform four easy steps and the GeneXpert System does the rest.

Fully-Controlled
Xpert GBS can lower healthcare costs and reduce patient hospital stays. By identifying mothers colonized with GBS, the test enables more targeted and effective antibiotic prophylaxis. This can prevent illness in a greater number of infants and reduce unnecessary antibiotic use in uncolonized women and the emergence of antibiotic-resistant GBS strains.

Rapid and Accurate. It’s About Time.
"The GeneXpert® System is an important new development in the field of molecular diagnostics. The test is moderately complex, but the assay is simple enough to be performed reliably by individuals without a background in nucleic acid diagnostics."
- Gessoni, et al.
Clinica Chimica Acta, January 2012
Runs On: GeneXpert® System

The Need :
Thrombophilia is defined as an increased risk or tendency to develop blood clots as a consequence of predisposing factors that may be inherited or acquired. A thrombus may form in either the venous or arterial vascular system. Venous thrombophilia is usually related to an abnormality of the coagulation system and may result in deep venous thrombosis (DVT) or pulmonary embolism (PE).

Historically, laboratory analysis for thrombophilia has consisted primarily of detecting deficiencies of Antithrombin, Protein C and Protein S, and testing for dysfibrinogenemia and antiphospholid antibodies/lupus anticoagulants.

In the last decade it has been shown that venous thromboembolism is a complex pathology that is reliant upon the interaction of both acquired and genetic factors. In this regard, FII and FV Leiden mutations play an important role in the pathogenesis of DVT in combination with acquired factors such as age.

The Solution :
Xpert® FII & FV is a qualitative genotyping test for the rapid detection of Factor II (FII) and Factor V (FV) alleles. Performed on the Cepheid GeneXpert System, the test is intended to provide rapid results for FII (G20210A) and FV Leiden (G1691A) mutations as an aid in the diagnosis of suspected thrombophilia.

Simple

• Molecular lab in a cartridge: DNA Extraction, amplification and detection in one cartridge.
• 24/7 availability: Run daily, or on-demand, with a simplified workflow.

Clinically Validated

• Proven accuracy: Multi-site study verified over 1,000 patient samples with results comparable to those obtained with bi-directional sequencing

Fast

• On-demand: 30 minute FII and FV genotyping
• Actionable: No added wait time to obtain complete thrombophilia work-up

Cost-efficient

• Avoids expensive ‘send-outs’ to reference labs.
• Optimize labor resources: No specialized personnel or lab facilities required.

Cepheid's Xpert FII & FV test provides on-demand results you can trust and empowers your clinical team to better manage patients.

Healthcare's #1 choice for on-demand MRSA testing.
"The GeneXpert® System has taken the TAT of results from 2-3 days down to a few hours. Now we do not have to presumptively isolate patients. This has helped to reduce nursing labor, improve bed management and reduce isolation costs in the ICU."
-Mary Jane Larmon, RN, BSN, MBA
ICU Nurse Manager, Sharon Regional Health System
Runs On: GeneXpert System

The Need :
MRSA infections are costly.
The human and financial impact of MRSA is high :

In USA :

• MRSA accounted for greater than 60% of hospital-acquired S. aureus infections in 2004.
• Over 278,000 hospitalized persons are infected by MRSA annually.
• Over 17,000 MRSA-related hospitalizations end in death.
• Over $2.5 billion excess health care costs are attributable to MRSA infections.

The Solution
Rapid Active MRSA Surveillance Testing and Infection Control.

• Reduction of healthcare-associated MRSA infections starts with active surveillance - Xpert® MRSA provides on-demand results in 66 minutes or less and has been proven to optimize effectiveness of infection control programs.
• Xpert MRSA provides on-demand results - rapid identification of colonized patients allows for immediate actions for improved patient outcomes and reduced LOS.

"A rapid test for both SA and MRSA colonization has many applications, including assisting physicians in targeting appropriate prophylactic therapy and decolonization to reduce the risk of post-surgical site infections." -Samir S. Awad M.D.
Associate Professor in the Michael E. DeBakey Dept. of Surgery, Baylor College of Medicine, Houston, Texas Director of Surgical Intensive Care Unit, Veteran Affairs Medical Center, Houston
Runs On: GeneXpert® System

The Need :
Staphylococcus aureus infections are an increasingly serious public health issue.
Colonized patients at risk for serious complications include surgical, trauma, burn and dialysis patients:

• S. aureus colonized patients are up to 9 times more likely to develop surgical site infections than non-carriers.
• S. aureus is the major cause of access infections and bacteremia in dialysis patients
• Carriage is the major risk factor for infection with
• S. aureus in dialysis patients
• Up to 93% of nosocomial S. aureus infections are caused by a patient's own flora
• Up to 93% of nosocomial S. aureus infections are caused by a patient's own flora
• SA and MRSA infections are associated with increases in length of hospital stay, costs, morbidity, and mortality
• Nasal carriage of S. aureus and self-infection of wounds in ICU/Burn patients is well documented

The Solution :
Rapid and accurate detection of colonization facilitates targeted infection control practices :

• Optimize pre-admission workflow and counseling.
• Enables measures to reduce endogenous infection risk, including decolonization.
• Supports measures to reduced exogenous infection risk, including barrier/contact precautions.
• Aligns with infection control strategies as outlined by SCIP and SHEA/IDSA.

The tremendous increase of both hospital acquired and community acquired MRSA in skin and soft tissue infections requires a change in management of these infections. Cepheid's on-demand Xpert® MRSA/SA SSTI test detects the presence of S. aureus (SA) or methicillin-resistant S. aureus (MRSA) in skin and soft tissue infections in less than one hour.
Runs On: GeneXpert® System

SSTIs are a major health concern

• The most common cause of skin and soft tissue infections is Staph aureus; MRSA represents over 50% of these infections in parts of the U.S.
• Current laboratory methods can take up to 72 hours to determine if a SSTI is SA or MRSA.
• Empiric treatment, found to be incorrect in 57% of patients according to one study, is employed due to lack of a rapid identification method.

The only rapid and comprehensive SSTI test available

• Xpert MRSA/SA SSTI is a rapid, on-demand test for detecting MRSA and SA from skin and soft tissue swabs in less than one hour.
• Xpert MRSA/SA SSTI is the most comprehensive Staph aureus test available :
  • Includes targets for Staph aureus, MRSA, and mecA.
  • Identifies presumptive positive "empty cassette" strains for correct classification as SA sensitive.
  • Unparalleled automation with the GeneXpert® System provides reduced hands-on time and improved laboratory efficiency.

Important healthcare benefits of rapid detection

• Helps ensure the right therapy sooner for improved patient management.
• Enables a targeted antimicrobial therapy approach for better antimicrobial stewardship.
• Allows for immediate identification of patient infection for improved isolation and infection control measures.

Life threatening cases of severe sepsis, caused by deadly blood stream infections, continue to be an urgent healthcare concern in hospitals across the world. Aggressive management of severe sepsis is crucial to improving outcomes - with timely diagnosis as the critical first step. Cepheid's on-demand Xpert® MRSA/SA BC test detects the presence of methicillin-resistant S. aureus (MRSA) or S. aureus (SA) in gram positive blood culture bottles in less than one hour.
Runs On: GeneXpert® System

Blood stream infections are a major healthcare concern

• Severe sepsis strikes 750,000 people annually in the U.S., resulting in mortality rates of up to 50%. MRSA and S. aureus are the causative pathogen in up to 35% of severe sepsis cases.
• Current culture-based lab testing methods for gram positive blood culture bottles require an additional 18-48 hours for determination of MRSA or SA.
• In the absence of timely diagnostic results, clinicians often employ empiric treatment approaches, using broad-spectrum antimicrobial therapies that can be costly, ineffective and contribute to an increase in drug resistance

On-demand molecular testing — an ideal solution

• One hour positive blood culture bottle results for both MRSA and SA.
• Outstanding clinical performance.
• Results available around the clock.
• Easily integrates into institution septic bundle processes.

Critical healthcare benefits in rapid detection

• Allows de-escalation from broad-spectrum therapy to a targeted antimicrobial approach 18-48 hours sooner.
• Enhance patient outcomes.
• Reduce length of stay.
• Improve antimicrobial stewardship and help ensure appropriate infection control procedures.

Rapid and Accurate. It’s about time
The alarming rise in the incidence of Clostridium difficile infection (CDI) highlights the need for rapid and accurate diagnostic solutions. Today's testing methodologies have forced clinicians to choose between solutions that deliver either speed or accuracy.
Xpert®C. difficile delivers both.
Runs On: GeneXpert® System
Runs On: GeneXpert® System

The Need
The alarming rise in the incidence of Clostridium difficile infection (CDI) highlights the need for rapid and accurate diagnostic solutions :

• Sensitivity of current available rapid diagnostic tests are unacceptably low.
• Additional length of stay increase caused by C. difficile infection is 5.6 days.
• Incremental costs due to C. difficile infection can be as high as $7,179 per patient

Management of CDI requires rapid and accurate diagnosis. Cepheid's Xpert C. difficile delivers both while enabling clinicians to optimize patient management and reduce length of stay.

The Solution
Today's testing methodologies have forced clinicians to choose between solutions that deliver either speed or accuracy. Cepheid's 45-minute Xpert C. difficile delivers both :

• Superior test accuracy eliminates the need for additional or repeat testing.
• Rapid identification of infected patient helps infection control efforts.
• Timely reporting enables clinicians to administer appropriate therapy thereby improving patient management

Cepheid's Xpert C. difficile test provides on-demand results you can trust and empowers your clinical team to better manage patients.

45-minutes. No compromises.
Vancomycin Resistant Enterococcus (VRE) is a critical pathogen among high risk patients. Previous testing methodologies are time consuming and often require unnecessary isolation. Xpert® vanA empowers clinicians to make critical decisions at time of patient admission, thereby improving the quality of patient care and reducing cost.
Runs On: GeneXpert® System
Runs On: GeneXpert® System

The Need
According to the Centers for Disease Control and Prevention (CDC), Enterococci cause about 1 of every 8 hospital infections with 30% of those infections, caused by Vancomycin-Resistant Enterococci (VRE). However, VRE can be even more prevalent in high risk groups, such as immunocompromized and ICU patients.
The human and financial impact of VRE is high:

• Attributable mortality: 10%
• Extended length of stay: 6.2 days
• Incremental cost: $12,800

The Solution
The CDC and SHEA have both published guidelines on how to reduce or eliminate healthcare associated infections. As a part of a quality infection control program, Cepheid's Xpert vanA provides :

• Immediate detection of the vanA gene most closely associated with VRE colonization.
• Superior NPV required in a surveillance test.
• Easy-to-use test with less than 2 minutes hands-on-time.

Now Aligned to the World Health Organization's BCR-ABL Standards with Every Lot "Cepheid's Xpert® BCR-ABL Monitor test is a powerful tool for monitoring patients being treated for Chronic Myelogenous Leukemia. The unsurpassed sensitivity of the GeneXpert® System enables clinicians to process molecular tests in their own facilities instead of sending patient samples to a central lab and waiting for results. A patient's local clinician can now monitor minimal disease levels very quickly - the key to appropriately managing patients who may be at risk for relapse."
- Dr. Ellie Nacheva, MD PhD FRCPath
Head of Lab - Leukemia Cytogenetics,
Royal Free and University College School of Medicine
Runs On: GeneXpert® System

The Need : Current Guidelines
Current practice guidelines from Europe Against Cancer and National Comprehensive Cancer Network (NCCN) for management of patients with CML call for use of quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML, in monitoring for minimal residual disease, and in identifying patients who may be at a high risk for relapse.

RT-PCR :
RT-PCR has been shown to be an accurate and highly sensitive method for detection of the BCR-ABL fusion gene, and is more sensitive than Fluorescence In Situ Hybridization (FISH) or cytogenetics.
An additional advantage of quantitative PCR versus FISH and cytogenetics is the high correlation of PCR results obtained from bone marrow and peripheral blood samples. Therefore, PCR may potentially reduce the bone marrow aspirations currently required in patients with CML.

International Standardization :
The clinical utility of monitoring BCR-ABL mRNA levels has become standard of care in aiding physicians in managing their CML patients. Therefore, it is essential that variation between and within laboratories remain low.

The Solution : Xpert BCR-ABL Monitor
Xpert BCR-ABL is a real-time RT-PCR (Reverse Transcription Polymerase Chain Reaction) test intended as an aid in the monitoring of the p210 BCR-ABL translocation in peripheral blood lymphocytes (PBL) of patients with chronic myelogenous leukemia (CML). This revolutionary test offers unique features not available in current testing methods, including: minimal hands-on time while delivering answers in less than 2 hours.

The GeneXpert System :
The GeneXpert is the only system to combine sample preparation with real time PCR amplification and detection for fully integrated and automated nucleic acid analysis. The system purifies, concentrates, detects, and identifies targeted nucleic acid sequences in less than 2 hours. The GeneXpert System requires minimal hands on time. For BCR-ABL, after a short sample preparation step users simply add selected reagents and the prepared sample to the cartridge and the GeneXpert System does the rest.

GeneXpert BCR-ABL / ABL Monitor Test (IS)
Xpert BCR-ABL/ABL test reports results to the International Scale by using an assay-specific conversion factor determined by comparison to an IS reference assay. Reporting to the International scale gives reliable and consistent results allowing physicians to better manage their patients and facilitating assessment of a major molecular response (MMR=3 log reduction from the IS baseline).