Centralized Diagnostics

• 9-minute STAT Parathyroid Hormone test: the first 9-minute STAT PTH test on an automated immunoassay platform. This in-vitro test provides quantitative results on the amount of parathyroid hormone in human serum and plasma to diagnose hypercalcemia and hypocalcemia, which helps physicians diagnose thyroid dysfunction. The test is available on the Elecsys^® 1010 and 2010 systems and cobas e 411 analyzer.

• Roche CARDIAC D-Dimer:  FDA-cleared Roche D-Dimer test to rule out deep vein thrombosis and pulmonary embolism when used in combination with a non-high clinical probability score. It is the first D-dimer test to offer the exclusion claim on a fully automated clinical chemistry analyzer that allows consolidation of D-dimer testing with routine testing.
• Mycophenolic Acid:  the first FDA cleared Mycophenolic Acid assay for use on the Roche COBAS Integra^® and cobas c 501 analyzers to help manage MPA therapy in renal and cardiac transplant patients.

• Elecsys^® proBNP assay:  the first fully automated test used for detecting the level of the NT-proBNP peptide as an aid in the diagnosis of congestive heart failure (CHF) in patients and risk stratification in CHF and in acute coronary syndrome.
• Roche Troponin T: an aid in the differential diagnosis of acute coronary syndrome, for risk stratification in patients with acute coronary syndrome, and for cardiac risk in patients with chronic renal failure. 
• Direct LDL: a non-fasting test that gives the true blood measurement of LDL cholesterol.
• Beta Crosslaps: a bone marker test that monitors antiresporptive therapies in postmenopausal women and osteopenic individuals.
• Tumor Markers: biochemical tests that aid in the diagnosis and management of patients with cancer.
• MODULAR ANALYTICS instrument: fully automated and integrated immunoassay and clinical chemistry system. Testing includes: anemia, fertility, cardiac tests, thyroid function, tumor markers, bone markers and many others.
• MODULAR Pre-ANALYTICS EVO System: allows laboratories to automate centrifugation, destopping, aliquoting, barcoding, restopping, storing and sample transfer from a single point of entry.
• cobas^® 6000 analyzer series:  provides laboratories with an integrated clinical chemistry (cobas c 501 analyzer) and immunoassay (cobas e 601 analyzer) testing platform as well as a small footprint and an easy-to-use interface. The cobas 6000 analyzer series delivers approximately 95 percent of a lab’s typical testing mix of more than 130 assays.
• cobas e 411: provides a large menu of tests, nine-minute turnaround time for critical care tests and the ability to operate independently as a dedicated stat analyzer or as a part of a networked clinical laboratory environment.

Molecular Diagnostics

Roche molecular products are derived from processes described as polymerase chain reactions, also known as PCR, a Roche Nobel Prize-winning technology. PCR is a biochemical process that allows minute amounts of genetic material to be amplified into billions of copies in just a few hours. PCR has enabled many significant advances in the Human Genome project, DNA fingerprinting, and in the diagnosis and monitoring of diseases, such as HIV/AIDS and hepatitis.

• COBAS ^® AmpliPrep^® System/COBAS^® TaqMan^®  HIV-1 Test: this highly accurate test is the first fully automated HIV-1 diagnostic tool using real-time PCR technology in the United States. It provides a broader range of viral load data than earlier generation tests, quantifying the amount of virus in the blood from very high to very low levels. With the test, labs can deliver highly accurate results faster – a decisive advantage for doctors monitoring how well a chosen therapy is working for the patient.

• COBAS^® AmpliPrep^® System/ COBAS^®  TaqMan^® HCV Test: this automated test that measures how well a patient infected with Hepatitis C is responding to therapy has been submitted to the U.S. Food and Drug Administration for in-vitro diagnostic status, but is not approved for use in the United States. The test is designed to provide highly accurate information about the quantity of Hepatitis C virus in a patient’s blood from very high to very low levels. The test, currently available for research, uses nucleic acid amplification for the quantitation of HCV RNA in human serum or plasma. Sample Prep is automated using the COBAS^® AmpliPrep^® Instrument with amplification and detection automated using the COBAS^® TaqMan^® Analyzer.

• AmpliChip^® CYP450 microarray:  the first FDA-approved microarray-based test analyzes a patient’s Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a blood sample. Test results will allow physicians to consider unique genetic information from patients in selecting medications and doses of medications for a wide variety of common conditions such as cardiac diseases, psychiatric disease and cancer.
• COBAS^® Amplicor^® Clamydia T and N gonorrhea assay: uses PCR for highly sensitive and specific laboratory testing.
• Factor II (Prothrombin) and V (Leiden): the first FDA-cleared DNA-based test for an inherited genetic marker; used as an aid in the diagnosis of people with increased risk of developing deep vein thrombosis.
• COBAS^® Amplicor^® HIV - 1 Monitor Test (version 1.5):  an enhanced version of PCR assay used to measure the amount of HIV-1 RNA (viral load) present in an infected person’s blood.
• COBAS^® AmpliScreen^® HCV Test, version 2.0 and COBAS AmpliScreen HIV Test, version 1.5 for blood screening: use PCR-based nucleic acid based technology and are qualitative in-vitro tests for the direct detection of Hepatitis C (HCV) virus RNA and Human Immunodeficiency Virus (HIV-1) RNA in human plasma from donations of whole blood and blood components for transfusion.

Point of Care Diagnostics

·        ACCU-CHEK^® Inform system: a hospital blood glucose meter that allows operators to enter information for six common manual point-of-care tests: visual urinalysis, rapid streptococcus, rapid drugs of abuse testing, pregnancy, fecal occult blood and gastric occult blood.

• CoaguChek^® XS System: a point-of-care PT/INR testing monitor in physician offices for monitoring patients on Coumadin® (warfarin sodium) therapy.
• cobas^® b 221 blood gas analyzers: tests blood gases, electrolytes, total hemoglobin, hemoglobin derivatives, hematocrit bilirubin and FDA cleared pH pleural fluid in hospitals.

Applied Science*

• Genome Sequencer FLX System: uses nanotechnology to help researchers read the sequence of an entire genome in just weeks – drawing the map that provides a complete inventory of a living thing’s traits and genetic predispositions. 454 Life Sciences, a Roche subsidiary, completed the full genome of a single human in less than six months, moving this innovative technology down the path to the vision of the $1,000 genome.
• LightCycler^® 480 Instrument: performs rapid, real-time, online quantitative polymerase chain reaction (PCR) for gene detection, gene quantification, and genotyping and gene scanning for research applications.
• MagNA Pure^® LC System: used in life science research, comprises the MagNA Pure LC Instrument, computer, software, disposable plastics, and reagent kits for fully automated nucleic-acid isolation and PCR setup.
• FuGENE^® HD Transfection Reagent: an easy-to-use, low cytotoxicity reagent that produces high-efficiency transfection in hundreds of different cell types, including difficult-to-transfect cell lines. This reagent also can be used in cancer and stem cell research.

Diabetes Care

• ACCU-CHEK^® Aviva blood glucose meter:  the newest ACCU-CHEK^® blood glucosesystem is designed to help people with diabetes test right the first time with a unique test strip, allowing for ease of handling and ease of dosing, five-second test time, alternate site testing (physician consultation recommended), and underdose detection features.
• ACCU-CHEK^® Compact blood glucose meter:  offers all-in-one convenience with the integration of revolutionary 17-test strip drum into the meter for no individual strip handling, no coding for fewer steps and a detachable lancet device.
• ACCU-CHEK^® Multiclix lancet device:  has a pre-loaded six-lancet drum and a patented cam-driven, linear tract design, which reduces tearing of skin. It also includes personalized depth settings with 11 different depth choices to avoid nerve fibers.

·        ACCU-CHEK^® Spirit insulin pump: features a full set of tools for monitoring, analysis and insulin delivery, including the ACCU-CHEK^® Spirit insulin pump, ACCU-CHEK^® Pocket Compass software with bolus calculator on a Palm™ PDA or Smartphone, and a choice of the ACCU-CHEK^® Aviva, ACCU-CHEK^® Compact Plus or ACCU-CHEK^® Active blood glucose meter kit.

• ACCU-CHEK^® Tender infusion set: has a 30-45° insertion angle and soft Teflon cannula, which is flexible and moves with the user for added comfort.

ACCU-CHEK, LightCycler, COBAS, TaqMan, AmpliPrep, AmpliChip, Amplicor, AmpliScreen, Elecsys, MagNA Pure  and COAGUCHEK are trademarks of Roche.

All other product names and trademarks are the property of their respective owners

* For life science use only, not for diagnostic purposes.