Roche Diagnostics  

9115 Hague Road
Indianapolis,  IN  46256

United States
http://usdiagnostics.roche.com
  • Booth: 4606

Profile

Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. The world’s largest biotech company, Roche is the world leader in in vitro diagnostics and tissue-based cancer diagnostics and is a front runner in diabetes management. The company’s personalized healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Specifically, Roche Diagnostics offers healthcare solutions focused on increasing medical value and testing efficiency. These include: integrated clinical chemistry and immunoassay analyzers and automation systems; PCR-based molecular diagnostics; handheld blood glucose monitors and other point-of-care testing devices for hospitals, clinics, physician offices and patients; genomic sequencing and gene expression detection for life science research; and integrated slide staining and workflow management platforms for anatomic pathology.


 Press Releases

  • Media Release 

    Indianapolis, May 1, 2017

    FDA clears Roche high-volume immunoassay lab testing solution to support critical medical treatment decisions

    cobas® e 801 module delivers on the promise of next-generation laboratory efficiency

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

    As core laboratories continue to evolve to meet the growing workload demands in an increasingly challenging environment, the cobas e 801 module offers greater testing efficiency, superior reagent management and industry-leading turnaround time for critical diagnostic tests. Designed for maximum consolidation at a high throughput, the module reduces generated waste, for more environmentally sustainable testing.

    “The cobas e 801 module truly is a transformative solution,” said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. “Patients and the physicians who serve them need medically relevant answers, faster and with ever greater precision. This clearance delivers the instrumentation cornerstone of the next-generation lab—high throughput, agility and intelligence.”

    The cobas e 801 module almost doubles the currently available immunoassay testing capacity on the same footprint, delivering up to 300 tests per hour and providing 48 reagent channels.

    Designed to use at least 25% less patient sample than its predecessor, the analyzer offers an extensive assay menu and delivers speed, accuracy and consistency.

    Advances that speed patient care

    The cobas e 801 module is the newest member of the cobas 8000 modular analyzer series, delivering immunoassay testing across a wide range of disease areas. Up to four cobas e 801 modules can be configured in a series, delivering up to 1,200 tests per hour across up to 192 reagent positions. The system may also be integrated with the cobas 8100 automated workflow series and Roche Middleware featuring Lab Intelligence.

    The cobas e 801 module allows for continuous, on-the-fly loading of reagents and consumables and has a high uptime, while requiring less hands-on time. A new reagent pack design has increased reagent onboard stability to 16 weeks, allowing labs to reduce send-out testing and minimize reagent waste.

    The cobas e 801 module will continue to deliver Roche’s industry-leading 9-minute STAT assays, allowing labs to reduce turnaround time for critical testing, such as cardiac markers. The small sample volumes required for testing are beneficial for patients, especially special populations like pediatrics and the critically ill.

    About Roche

    Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

    Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

    Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

    The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. 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.

    For further information, please contact:

    Christina Vysma

    Communications Business Partner

    Centralized Diagnostics

    Roche Diagnostics Corporation

    Indianapolis, Indiana USA

    (317) 521-4370

    christina.vysma@roche.com

  • Media Release                                                 

    Indianapolis, January 19, 2017

    Breakthrough development for Americans with suspected heart attack – Next generation Troponin T test from Roche cleared by FDA

    New Troponin T 9-minute test offers greater sensitivity in the diagnosis of myocardial infarction

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected  heart attack. With this clearance, Roche is the first IVD company in the U.S. to provide the next generation Troponin testing for patients as an aid in the diagnosis of myocardial infarction, enabling clinicians to more accurately identify patients experiencing a heart attack.

    Every minute counts
    Every 43 seconds someone in the U. S. has a heart attack, or acute myocardial infarction (AMI), which occurs when the blood supply to an area of the heart is interrupted. The longer time the heart is without proper blood supply, the greater the damage.  Troponin, a specific marker of cardiac cell death, is released into the blood stream when cardiac cells are being damaged.

    Patients with chest pain and other symptoms suggestive of AMI account for approximately 8 million of all emergency room consultations in the U.S., but only a fraction of them (5-20%) are actually having an AMI. Hence, fast and accurate diagnosis of AMI requires sensitive diagnostic tests that can detect early troponin release, allowing healthcare providers to make confident clinical decisions for their patients and appropriately manage hospital resources. In a heart attack, early diagnosis and initiation of treatment can reduce the amount of cardiac cell death thus potentially saving and improving quality of lives. This next generation Troponin T test from Roche is able to provide accuracy at lower levels of troponin to aid in correctly identifying patients having an AMI.

    Moreover, this next generation of TnT test from Roche has been available in the rest of the world for the past seven years during which time it has been rapidly adopted by clinicians and its clinical diagnostic utility is supported by more than 600 peer-reviewed publications.

    “As an emergency doctor whose job is to make decisions on patients with chest pain, my ability to do this safely and accurately is driven by the sensitivity of the troponin assay. FDA clearance of this new Roche TnT assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain.”

    Frank Peacock MD, FACEP – ED Physician

    Baylor Medical Center Houston – Houston, TX

    The Elecsys TnT Gen 5 test from Roche enables better decisions

    The Elecsys® Troponin T Gen 5 STAT test from Roche detects cardiac troponin which is the preferred biomarker for the diagnosis of heart attack in clinical practice. In combination with an electrocardiogram (ECG) and signs of ischemia, troponin has become the gold standard as an aid in the diagnosis of heart attack. The higher sensitivity of the Roche TnT Gen 5 STAT assay in conjunction with the rapid turnaround time of nine minutes can significantly accelerate decision-making, and allows the detection of smaller infarctions thereby maximizing the potential for effective treatment.

    With such compelling clinical utilities and the automation advantages associated with Roche solutions, the Elecsys TnT Gen 5 STAT test can provide the confidence that healthcare professionals need to diagnose and manage patients in emergency settings and beyond.

    About Roche

    Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

    Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

    Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, anti-malarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

    The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. 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.

    For further information, please contact:

    Christina Vysma

    Roche Communications Business Partner

    Roche Diagnostics Corporation

    Indianapolis, Indiana USA

    (317) 292.2920

    christina.vysma@roche.com

  • Media Release

    Pleasanton, 1 August 2016

    Roche receives CLIA waiver for cobas® Influenza A/B & RSV test for the cobas® Liat®

    The first CLIA-waived, real-time PCR test that differentiates flu and RSV in 20 minutes is available now for use in physician offices and urgent care settings

    Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B & RSV test for use on the cobas® Liat® System. Roche is the first manufacturer to extend the value of highly accurate CLIA-waived molecular testing beyond flu A/B and strep A to include Respiratory Syncytial Virus (RSV), a cause of more than 80% of acute lower respiratory tract infections in infants under one year of age.1

    “For young children and the elderly, it is essential to have a differential diagnosis for RSV and flu to ensure appropriate treatment within a short time frame after symptoms strike,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “This can be challenging with current turnaround times for lab-based test results. The cobas® Influenza A/B & RSV test provides lab-quality PCR results for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients.”

    In the US, an average of 58,000 hospitalizations and 2.1 million outpatient visits in children under five years are attributed to RSV. A significant number is also seen in adults over 65 years with 177,000 hospitalizations and 14,000 deaths per year2. A quick detection and discrimination of flu and RSV enables clinicians to optimize patient management and antiviral treatment.

    The cobas® Influenza A/B & RSV test is the third assay on the cobas® Liat® System to receive CLIA waiver, following the cobas® Strep A and cobas® Influenza A/B tests, which received CLIA waiver in May and September 2015, respectively. The cobas® Liat® Analyser and all three assays are FDA cleared and CLIA waived.

     

    F. Hoffmann-La Roche Ltd          4070 Basel

    Switzerland

     

    Group Communications Roche Group Media Relations

     

    Tel. +41 61 688 88 88

    Fax +41 61 688 27 75

    www.roche.com

     

    About the cobas® Influenza A/B & RSV test

    The cobas® Influenza A/B & RSV test uses real-time PCR (polymerase chain reaction) technology to detect and differentiate influenza A virus RNA, influenza B virus RNA and respiratory syncytial virus (RSV) RNA in about 20 minutes. It targets well-conserved regions of influenza A, influenza B and RSV RNA to provide broad strain coverage and has been validated on over 40 commonly found strains of influenza A and B and seven commonly found strains of RSV.

    About the cobas® Liat® System

    Utilizing PCR technology, the cobas® Liat® System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. In addition to the existing tests for influenza A/B, strep A and influenza A/B & RSV, assays for other infectious diseases are in development.

    About real-time PCR

    Real-time PCR is widely recognized as the gold standard for molecular testing. It is highly accurate and offers a low limit of detection (LOD) to detect viruses in patients with low viral load, such as some adults with influenza infection. PCR is also extremely versatile, offering capabilities with high multiplex testing (e.g. influenza A, influenza B and RSV in the same test), quantification (viral load count), and detection. Additionally, compared to physician clinical management, rapid antigen testing and other point-of-care testing methods, real-time PCR has demonstrated improved detection of influenza.3,4

    More information is available at go.roche.com/cobasliat or www.cobasliat.com.

    The cobas® Liat® System is not commercially available in all markets.

    About Respiratory Syncytial Virus

    RSV is one of the most contagious human pathogens, but with limited antigenic and strain diversity.5  It is the most common cause of childhood acute lower respiratory tract infection (LRTI), causing more than 60% of acute LRTI in children, and more than 80% in infants under one year of age.6 Symptoms of adults with RSV infection are usually consistent with an upper respiratory tract infection such as the common cold. Acute illness lasts 5–10 days, but the cough may be prolonged for several weeks.7 Mild RSV infections are resolved without treatment, but

     

    infants and children with a severe RSV infection may be admitted to the hospital.8 Real-time PCR assays are recommended due to their high sensitivity, particularly since many patients may have low viral loads.9

    About influenza A and B (flu)

    Influenza is an acute respiratory illness caused by infection with the influenza virus. Influenza viruses consist of three types: influenza A, influenza B and influenza C. In the U.S., influenza A/H1N1, A/H3N2 and influenza B are the predominant seasonal viruses. Influenza A and B viruses are among the leading causes of respiratory infections, estimated to affect 5-10% of adults and 20-30% of children worldwide every year. Influenza is primarily spread by breathing in infected droplets formed when a person with the flu sneezes, coughs, or talks. Symptoms include fever, cough, headache, fatigue, muscle pain, sore throat, and runny nose. Elderly people, young children, and people with weakened immune systems or chronic medical conditions can be at high risk for serious disease. Each year, approximately 3 to 5 million people develop severe illness and 250,000 to 500,000 people die from the flu.10

    About Roche

    Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

    Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

    Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

    The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of

     

    CHF 48.1 billion. 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.

    COBAS and LIAT are trademarks of Roche.

    For media inquiries please contact:

    Bob Purcell, Roche Molecular Diagnostics 1-888-545-2443

    References

    1 Piedimonte G, Perez MK. (2014). Respiratory Syncytial Virus Infection and Bronchiolitis. Pediatrics in Review. 35:519-530.

    2 CDC RSV Trends and Surveillance. Available at: http://www.cdc.gov/rsv/research/us-surveillance.html Last accessed 6 June 2016. 3 Hazelton et al. (2015) Detection of influenza A and B with the AlereTM i Influenza A & B: a novel isothermal nucleic acid amplification assay. Influenza and Other Respiratory Viruses 9(3), 151–154.

    4 Dugas et al. (2015) Clinical diagnosis of influenza in the ED. AJEM 33 (2015) 770–775. http://dx.doi.org/10.1016/j.ajem.2015.03.008 5 Collins LP, Graham BS (2008). Viral and Host Factors in Human Respiratory Syncytial Virus Pathogenesis. J Virol. 82:2040-2055.   jvi.asm.org/content/82/5/2040.full

    6 Piedimonte G, Perez MK. (2014). Respiratory Syncytial Virus Infection and Bronchiolitis. Pediatrics in Review. 35:519-530.

    7 CDC (2010). Respiratory syncytial virus clinical description and diagnosis. Available at http://www.cdc.gov/rsv/clinical/#clinical Last accessed 6 May 2016.

    8 National Institute of Health (2014). Respiratory syncytial virus. Available at  http://www.nlm.nih.gov/medlineplus/ency/article/001564.htm Last accessed 6 May 2016.

    9 CDC (2010). Respiratory syncytial virus laboratory testing. Available at http://www.cdc.gov/rsv/clinical/labtesting.html Last accessed 6 May 2016.

    10 World Health Organization. Influenza (Seasonal) Fact Sheet No 211. http://www.who.int/mediacentre/factsheets/fs211/en/. Accessed 6 May 2016.

  • Media Release                                                 

    Indianapolis, January 4, 2017

    Roche launches cobas® c 513 analyzer and HbA1c Gen. 3 assay to meet increasing demand for testing of people with diabetes

    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and HbA1c Gen. 3 assay has received 510(k) clearance  from the U.S. Food and Drug Administration (FDA).

    “As diabetes continues to approach epidemic proportions in the U.S. with an estimated 1.4 million American adults being diagnosed annually, the demand on healthcare providers and healthcare systems to keep up with this challenging health issue continues to increase,” said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. “With the FDA approval of the new cobas c 513 analyzer and proven HbA1c Gen. 3 assay, Roche is now positioned to help healthcare organizations address the increasing need for HbA1c testing with a dedicated solution that enables them to consistently deliver confident, efficient and high-quality results.”

    About the cobas c 513 analyzer  

    The cobas c 513 analyzer further increases laboratory efficiency by doubling the throughput to 400 patient results per hour with the same footprint as the COBAS INTEGRA® 800 CTS, which it replaces. Additionally, the cobas c 513 analyzer features direct results reporting, thereby minimizing the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. The analyzer also provides a high on-board test capacity of up to 18,000 tests and features closed tube sampling for greater lab efficiencies and maximum operator safety.

    About the HbA1c assay—a new standard in testing performance and efficiency

    The cobas c 513 analyzer runs the established Roche Tina-quant® HbA1c Gen.3 assay, which is also used across the Roche laboratory HbA1c portfolio, to ensure confidence, efficiency and high-quality results. It complies with current guidelines and recommendations for HbA1c testing and measures A1c as defined by IFCC/NGSP reference methods. With no interference by most known HbA1c variants, the Roche Tina-quant HbA1c Gen. 3 assay delivers accurate monitoring of HbA1c levels and results that clinicians and patients can have confidence in.

    About Roche

    Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare–a strategy that aims to fit the right treatment to each patient in the best way possible.

    Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

    The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. 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.

    For further information, please contact:

    Christina Vysma

    Communications Business Partner

    Roche Diagnostics Corporation

    Indianapolis, Indiana USA

    (317) 292-2920

    christina.vysma@roche.com


 Products

  • cobas® e 801 module 
    Roche is pleased to introduce the cobas® e 801 immunoassay module, the newest innovation in the cobas® 8000 modular analyzer series....
         

  • The cobas®801 module is the most powerful immunoassay analyzer Roche has engineered to date. Built for the growing lab, this standardized platform eliminates testing bottlenecks with nearly double the throughput in the same footprint as its predecessor; perfects reagent management with 48 channels, features on-the-fly loading and 112-day on-board stability, and requires up to six times less blood from the smallest patients. The cobas® e 801 module was designed to address the most critical pain points, enabling labs to accomplish more every day.

  • cobas® c 513 analyzer 
    This dedicated, high-volume HbA1c testing solution features high-quality components and offers functionalities designed to fulfill the needs of high-volume laboratories, while also meeting the new requirements for HbA1c testing....
         

  • The cobas® c 513 analyzer is a fully automated, high-throughput HbA1c testing solution. The module reaches a throughput of up to 400 determinations per hour. The reagent compartment has 60 reagent positions that can be loaded providing up to 14,000 results. The instrument features direct results reporting, thereby minimizing the risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This analyzer also offers close tube sampling, which reduces hands-on time, prevent sample contamination and ensure operator safety for laboratory personnel.
  • Tina-quant® Hemoglobin A1cDX Generation 3 Assay
    The Tina-quant® Hemoglobin A1cDX Gen 3 is intended for use as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent intended for the quantitative determination of % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood....
         

  • Roche is pleased to introduce the Tina-quant® Hemoglobin A1cDx Generation 3 reagent, the newest innovation in HbA1c testing, which is now available on the cobas® c 513 analyzer.  It features IFCC/NGSP certification, lot specific reagent calibration values, excellent precision, and no interference by common hemoglobin variants. 

    The Tina-quant® Hemoglobin A1c Generation 3 is also available on the cobas® c 4000, cobas® c 6000, cobas® c 8000 and Integra 400+ analyzers providing broad options, which allow the laboratory to more efficiently manage the increasing demands of HbA1c testing with high-quality results.
  • Elecsys® AMH Assay
    The automated Elecsys® AMH assay is intended for the assessment of ovarian reserve in woman presenting to fertility clinics in conjunction with other clinical and laboratory for fertility evaluation. Designed to offer excellent performance, the assay enables clinicians to provide patients with accurate results in only 18 minutes. ...
         

  • The automated Elecsys® AMH assay is intended for the assessment of ovarian reserve in women presenting to fertility clinics in conjunction with other clinical and laboratory tests for fertility evaluation. Featuring a duration time of only 18 minutes, the assay can be easily added to any of the automated cobas® analyzer platforms—making it ideal for fertility clinics seeking to have hormone and antral follicle count results during a patient’s office visit.

    The Elecsys® AMH assay provides a comprehensive in-office fertility assessment. The assay is correlated to the antral follicle count and demonstrates intermediate precision CV% less than 2.9% on all cobas systems. A measuring range of 0.03−23 ng/mL provides excellent low-end sensitivity.
  • Elecsys® Troponin T Gen 5 STAT 
    The automated Elecsys® TnT Gen 5 assay is intended to aid in the diagnosis of myocardial infarction (MI). As the only high-sensitive Troponin assay in the U.S. and designed to offer excellent precision, the assay delivers accurate results in only 9 minutes, enabling clinicians to accurately diagnose patients with a suspected heart attack....
         

  • The automated Elecsys® TnT Gen 5 assay, with higher sensitivity coupled with optimal precision (<4% CV) and rapid turnaround time (9 minutes), is intended to aid in the diagnosis of MI. With its STAT feature, the assay can deliver critical diagnostic information for MI patients for whom every minute counts.

    With a wide measuring range of 6 – 10,000 ng/L combined with sex-specific cutoffs, the TnT Gen 5 is the ONLY solution in the U.S that can be utilized to detect low levels of TnT to aid in decisively diagnosing MI.

    The availability of this automated Elecsys® TnT Gen 5 assay can enable clinicians, CVSL leaders and hospital administrators in the U.S. to realize better management of MI patients and associated outcome benefits.

  • Elecsys® BRAHMS PCT Assay
    Procalcitonin (PCT) is a sensitive and specific biomarker that provides insights into the severity of a bacterial infection both on presentation and during the course of treatment of sepsis patients. The Elecsys® BRAHMS PCT provides industry-leading precision and turnaround time as the only fully automated and integrated PCT solution in the U.S....
         

  • Roche Diagnostics recently launched the Elecsys® BRAHMS PCT, the first fully automated and integrated PCT solution. This game-changing launch was highlighted in CAP TODAY in January of 2017: “even though automated PCT assays were already available in the U.S. on the Brahms Kryptor and BioMérieux Vidas platforms—the FDA’s decision in June to approve an automated PCT BRAHMS assay for Roche Diagnostics’ Elecsys platform could significantly expand clinicians’ use of PCT. Requiring no reagent preparation or hands-on testing, the new test could make quick results more widely available, increasing the practicality of PCT… and reinforcing PCT’s increasingly central role in ameliorating sepsis.”
  • Elecsys® HIV Combi PT Assay
    The Elecsys® HIV Combi PT assay is intended for use as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute and primary HIV-1 infection....
         

  • The Elecsys® HIV combi PT assay is for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2 in human serum and plasma. This fourth-generation HIV immunoassay is able to detect both antigen and antibodies simultaneously thus increasing the likelihood of early detection and treatment for HIV patients, and helping to prevent the transmission of infection. The assay may be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than two years of age and in pregnant women.
  • cobas® Liat® PCR System 
    The cobas® Liat® PCR system is the only real-time PCR testing platform that’s CLIA-waived for Influenza A/B, Influenza A/B & RSV and Strep A, delivering results in 20 minutes or less. The system offers a simple workflow and definitive results that do not require interpretation. Confirmation of negative test results is not required at visit....
             

  • The cobas® Liat® PCR system is compact and includes the cobas® Liat® analyzer and the cobas® Liat® assay tube. The system is designed for on-demand STAT testing at the point of care or in the laboratory and is the only real-time PCR testing platform that’s CLIA-waived for Influenza A/B, Influenza A/B & RSV and Strep A, delivering results in 20 minutes or less. The system automates the entire testing process from sample prep to amplification to real-time detection and offers a simple 3-step, walkaway workflow and definitive results that do not require interpretation. Confirmation of negative test results is not required at the time of visit enabling clinicians to optimize patient treatment immediately.

  • Roche Inventory Solution 
    This new inventory management application from Roche is designed to address the specific needs of laboratories, optimizing supply chain processes and providing real-time management insights....
         

  • Roche Inventory Solution is designed to help laboratories optimize their inventory levels, ensuring there’s never too much (expiring inventory) on the shelves or too little (stock-outs), providing full transparency on a key cost driver.

    Using an intuitive handheld device, Roche Inventory Solution tracks deliveries and consumption. Based on user-defined min-max levels, consumption patterns and order data, the system indicates upcoming shortages, can suggest or even automatically trigger an order. The system works for any product from any vendor and provides management insights into the supply chain.

    Replicating the proven track record in lab processes, Roche has developed an inventory management solution that meets the specific needs of laboratories.

  • cobas® 6800/8800 System
    The cobas® 6800/8800 systems are fully automated solutions designed for both clinical and donor screening molecular testing. These moderate complexity systems provide unprecedented automation, high throughput, and onboard refrigerated reagent storage to drive transformative efficiency gains in a wide variety of laboratory environments....
               

  • The cobas® 6800/8800 systems are not mere instruments—they’re strategies for molecular leadership. These moderate complexity systems are creating new realities for how labs of all sizes can add distinctive value, not only throughout their lab, but their entire health system. Offering ready-to-use reagents, refrigerated storage, high throughput, and no daily maintenance requirements, this unprecedented automation can provide transformative efficiency gains. With a broad and expanding assay menu, labs have unlimited possibilities for clinical and operational excellence through real-time PCR technology, which has been proven in clinical trials and in the real world—providing continuity of care for patients, physicians and laboratorians.

  • CoaguChek® XS Plus System
    The CoaguChek® XS Plus system delivers CLIA-waived testing with enhanced connectivity for professional use....
       

  • The CLIA-waived CoaguChek® XS Plus system ensures accurate PT/INR results and offers data management capabilities for healthcare professionals who manage anticoagulation patients at the point of care. Additionally, CoaguChek® systems provide a standardized solution with a single-strip platform, 97% correlation to the lab, and heparin insensitivity.

    This small battery-powered, handheld meter provides accurate results in about 1 minute and enables immediate therapy decisions. The CoaguChek® XS Plus meter includes onboard controls and optional liquid quality controls providing flexible QC options for any testing environment.

  • Accu-Chek® Inform II
    The Accu-Chek® Inform II system is a total solution designed to help healthcare professionals provide the best care possible, delivering accurate results in 5 seconds. The system includes a wireless meter, patented test strip technology and easy-to-use lancing devices, which provide users with fast, reliable results, greater efficiency and support....
         

  • The Accu-Chek® Inform II system (wireless meter, patented test strip technology and easy-to-use lancing devices) works together to support users in providing the best patient care possible by providing the following features and benefits:

    • Fast, reliable results in 5 seconds with over 150 integrity checks to help ensure accuracy

    • Greater efficiency

    • Ongoing training and 24/7/365 technical support

  • Accu-Chek® Safe-T-Pro Plus lancet
    With the Accu-Chek® Safe-T-Pro Plus lancet, you’re able to provide patients comfort and your staff improved workflow efficiencies. This lancet is designed to reduce the spread of infection and meets the latest safety requirements, while minimizing pain for patients....
         

  • The Accu-Chek® Safe-T-Pro Plus lancet features three depth settings (1.3mm, 1.8mm and 2.3mm) and a retractable 23g needle to accommodate different skin types to best meet patient needs. It is designed to work seamlessly with the Accu-Chek® Inform II system, is suitable for all blood sampling needs, and is approved for use with neonates.

  • Elecsys® Syphilis Assay
    The Elecsys® Syphilis assay is intended for use as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms....
         

  • The Elecsys® Syphilis assay is intended for in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. This treponemal test detects antibodies directed against T. pallidum proteins. A positive treponemal antibody test result indicates exposure to syphilis. This assay may be used as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms. 

  • ROMA Calculation Tool
    The ROMA (risk of ovarian malignancy) calculation tool combines the results of the Elecsys® CA125 II, the Elecsys® HE4 assay and menopausal status into a numerical score used to determine the likelihood of finding cancer upon surgery in women presenting with an adnexal ovarian mass. ...
         

  • The likelihood for ovarian cancer in women presenting with an ovarian adnexal mass can determined using the ROMA calculation tool which combines the results of the Elecsys® CA125 II and the Elecsys® HE4 assay and menopausal status into a numerical score.  The ROMA calculation tool uses separate logistical regression equations and different cutoffs for premenopausal and post-menopausal women.  Compared to CA 125 alone, studies have shown ROMA demonstrated higher sensitivity and specificity in the detection of ovarian cancer. The calculation for used with the Elecsys® CA125 II and HE4 is provided in the package insert or can be downloaded directly onto a computer using the ROMA calculation tool thumb-drive.
  • Elecsys® Vitamin D total II Assay
    The Elecsys® Vitamin D total II assay is intended for use as an aid in the assessment of vitamin D sufficiency in adults....
         

  • The Elecsys® Vitamin D total II assay is for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This second-generation vitamin D immunoassay has an extended measuring range of up to 100 ng/mL, limiting the number of dilutions necessary to achieve the true sample result. In addition to the extended measure range, the assay cross-reactivity to D2 metabolite has increased. This vitamin D method has been standardized directly to Ghent ID-LCMS/MS.