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Roche Diagnostics  

9115 Hague Road
Indianapolis,  IN  46256

United States
http://usdiagnostics.roche.com
  • Booth: 1301

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

  • The VENTANA PD-L1 (SP142) Assay approved as a complementary diagnostic for TECENTRIQ™ (atezolizumab) immunotherapy

    Tucson, AZ, May 18, 2016 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval of the VENTANA PD-L1 (SP142) Assay1 by the US Food and Drug Administration (FDA) as a complementary diagnostic to provide PD-L1 status on patients who are considering treatment with the FDA approved Roche immunotherapy TECENTRIQ™ (atezolizumab) for metastatic urothelial cancer (mUC). This test is the first to evaluate patient PD-L1 status using immune cell staining and scoring within the tumor microenvironment, providing clinicians with information that may guide immunotherapy decisions2.

    This personalized cancer immunotherapy and complementary diagnostic is the first major advancement in more than 30 years in the treatment of urothelial cancer (UC) 3. UC is the fourth most common cancer in men in the United States and accounts for 5% of all new cancers reported. About 77,000 new cases of UC are diagnosed in the US annually, with approximately 16,000 deaths occurring each year. Men are three to four times more likely to suffer from this cancer4.

    “We are very pleased with the FDA approval of our PD-L1 assay as a complementary diagnostic with TECENTRIQ™,” said Ann Costello, Head of Roche Tissue Diagnostics. “Through collaboration with our Roche Pharmaceuticals colleagues, we are committed to transforming science through innovative diagnostics and breakthrough medicines, providing patients a deeper understanding of their disease and immunotherapy options.”

    “Roche’s ability to deliver a predictive test for our pathology customers, who provide important clinical information to oncologists, ultimately benefits patients in search of answers and treatment options,” said Jack Phillips, Head of Roche Diagnostics North America. “This assay, which supports patients with urothelial cancer – a disease with limited treatment options – has the potential to improve the standard of care."

    Roche will continue to pursue regulatory approval for the PD-L1 (SP142) assay in combination with TECENTRIQ™ in other cancer indications and in other countries. PD-L1 testing is not required for the use of TECENTRIQ™, but it may provide additional information for physicians and inform patient dialogue. The PD-L1 (SP142) assay is widely accessible for use with the company’s BenchMark ULTRA automated staining instrument.

    1This product is intended for in vitro diagnostic (IVD) use.                                                                      

    2The PD-L1 (SP142) assay is proven to select patients most likely to respond to treatment with TECENTRIQ™, as demonstrated by higher overall response rates in the IMvigor 210 clinical trial. The novel approach uses immunohistochemistry (IHC) technology designed to visually enhance and score PD-L1 protein on tumor-infiltrating immune cells. In an analysis based on 14.4 months of median follow up, TECENTRIQ™ shrank tumours (ORR) in 15 percent (95% CI: 11, 19) of  people evaluable for efficacy (n=310) whose disease progressed after platinum-based chemotherapy. TECENTRIQ™ shrank tumors in 26 percent (95% CI: 18, 36) of people whose disease had medium and high levels of PD-L1 expression (n=100). 

    3UC cancer is also known as urothelial cell carcinoma, transitional cell carcinoma or the urinary tract or urothelial bladder cancer. The majority of urothelial tumors arise in the bladder with the remainder originating in the renal pelvis, urethra or ureter.

    4American Cancer Society 2016 bladder cancer statistics.

     

    About the VENTANA PD-L1 (SP142) Assay

    The PD-L1 (SP142) assay is available on the BenchMark ULTRA automated staining instrument and uses the OptiView DAB IHC Detection Kit with OptiView Amplification. The PD-L1 (SP142) assay performs specific staining of tumor cells and immune cells.

    About atezolizumab

    For more information on atezolizumab, visit the Genentech website.

    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.

     

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 Products

  • cobas® c 513 analyzer*
    This new, 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....
           

  • Roche proudly introduces the cobas® c 513 analyzer, which 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 new analyzer will also offer close tube sampling, which will reduce hands-on time, prevent sample contamination and ensure operator safety for laboratory personnel.

    *510(k) pending. Not available in U.S.

  • cobas® connection modules (CCM)*
    Designed for high-throughput laboratories, cobas® connection modules (CCM) offers the ability to consolidate the vast majority of a laboratory’s testing volume, at high throughputs—up to 2,000 tubes per hour, while providing predictable workflow and turnaround times....
         

  • Roche introduces cobas® connection modules (CCM) to provide customers the ability to connect to the Roche standalone automation portfolio directly to Roche analytics without compromising the flexibility of the standalone automation concept.

    Based on its design, this high-volume automation solution adds value to a laboratory environment by providing convenient sample loading, quality and quantity checks, workflow flexibility and multidisciplinary connectivity, such as hematology, coagulation and the first IVD vendor to connect molecular testing solutions validated for cross-contamination compliance.

    With more than 200 CCM solutions shipped worldwide in just two years, CCM has demonstrated the market’s demand for a fast, accurate and flexible automation solution in the high-volume environment.

    *Not yet available for sale in the U.S.

  • CoaguChek® XS mPOC App Kit*
    Designed to operate on iOS devices, including iPhone and iPad, the CoaguChek® XS mPOC App works together with a patient’s CoaguChek XS meter and SmartClip to automatically transfer his or her PT/INR results to CoaguChek Link, where a physician is able to review the results....
           

  • Roche introduces the CoaguChek® XS mPOC App Kit, which is designed to provide self-testing patients on warfarin therapy with a convenient, easy-to-use mobile health solution that automatically and wirelessly transmits their PT/INR levels from the comfort of their own home to their physician via CoaguChek Link. This online system enables physicians to access and review patient PT/INR test results, enhancing systematic anticoagulation management.

    Each CoaguChek XS mPOC App Kit includes a CoaguChek XS meter with SmartClip and the CoaguChek XS mPOC App Kit, which operates on iOS devices, including iPhone and iPad.

     

    *Currently in development. Not available in the U.S. 

     

  • 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 & laboratory for fertility evaluation. The assay delivers accurate results in 18 min., enabling clinicians to provide patients with accurate results during their office visit....
       

  • Roche introduces the automated Elecsys® AMH assay, which 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 addition of 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.

    *510(k) pending. Not available in U.S.

     

  • Roche Elecsys BRAHMS PCT*
    The automated Elecsys® BRAHMS PCT assay is intended for the mortality risk assessment and management of Sepsis patients in hospitals in conjunction with other clinical evaluation. This test features an 18-minute duration time to provide fast and accurate results on the changes in PCT levels in patients with Sepsis....
         

  • New this year, Roche introduces the automated Elecsys® BRAHMS PCT assay, which is intended for the mortality risk assessment and management of Sepsis patients in hospitals along with other clinical evaluation. Featuring a short duration time of only 18 minutes, the Elecsys® BRAHMS PCT assay can be easily added to any of the automated cobas® immunoanalyzer platforms, making it ideal for institutions who provide care for Sepsis patients and seek the advantages of automation. The test also offers a broad measuring range which delivers excellent low-end sensitivity.

    *510(k) pending. Not available in U.S.

  • Elecsys® Anti-HCV Assay Gen 2
    The Elecsys® Anti-HCV II assay is designed for use as an aid in the presumptive diagnosis of HCV infection in people presenting signs & symptoms of Hepatitis C & in individuals who are at risk for Hep C infection. Improvements in this assay include: Liquid, ready-to-use reagents, Extended onboard stability (31 days), Increased specificity (98.8%) ...
       

  • Roche introduces the Elecsys® Anti-HCV II assay, which can be used as an aid in the presumptive diagnosis of HCV infection in people who present signs and symptoms of Hepatitis C and in persons who are at risk for Hepatitis C infection within pediatric and adult populations.  Improvements in this second-generation Anti-HCV assay include liquid, ready-to-use reagents and an extended onboard stability of 31 days. The performance of the assay is enhanced with an increased specificity (98.8%) and sensitivity (99.6%) demonstrated in a high-risk adult population.

    The Elecsys® Anti-HCV assay was positive earlier than the reference method in 6 of 16 seroconversion panels tested, indicating a more sensitive method in the recognition of early HCV infection.

  • Roche Inventory Solutions
    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 Solutions is designed to help laboratories optimize their inventory levels, ensuring that 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 Solutions 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 HIV
    The cobas HIV-1 test is a dual-target, real-time PCR assay that provides precise, quantitative HIV-1 RNA results with exceptional correlation to the COBAS® Ampliprep/COBAS® TaqMan® HIV-1 Test v2.0 that targets two unique, non-drug target regions of the genome....
     

  • The new cobas HIV-1 test is a dual-target, real-time PCR assay that provides precise, quantitative HIV-1 RNA results with exceptional correlation to the COBAS® Ampliprep/COBAS® TaqMan® HIV-1 Test v2.0 that targets two unique, non-drug target regions of the genome. The cobas HIV-1 test runs on the cobas 6800 and 8800 Systems, which are fully automated solutions designed for clinical and donor screening molecular testing. Based on Nobel-prize winning PCR technology, the systems are designed to transform the molecular workflow, delivering fully integrated automation, leading throughput, and high flexibility for routine molecular testing. Both systems enable simultaneous processing of multiple assays, order automation, and direct tube sampling from a variety of tube types. The cobas HIV-1 test has the only moderately complex categorization, and a reduced sample input.
  • cobas® Flu A/B & RSV Assay*
    The cobas® Flu A/B & RSV assay is a multiplex test that is designed to detect influenza A, influenza B and RSV concurrently. This real-time PCR-based assay provides definitive, lab-quality test results in about 20 minutes, enabling healthcare providers in all settings to provide patients with prompt, efficient and confident diagnosis and treatment....
           

  • Roche introduces the cobas® Flu A/B & RSV assay, which is a multiplex test that runs on the cobas® Liat PCR System, a compact, innovative, real-time platform designed for on-demand testing at the point of care or in the laboratory, to support time-sensitive diagnoses and treatment decisions. The information this test provides enables healthcare providers in all care settings to provide patients with quick, accurate diagnosis and treatment.

    *510 (k) pending. Not available in the U.S.

 

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