Diagnostics account for a small fraction of worldwide healthcare spending but contribute much to informed medical decision-making. Innovations in diagnostics can, therefore, make a major impact. At the 21st annual IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicines (EuroMedLab 2015; Paris, France), Roche (Basel, Switzerland) unveiled a series of new diagnostic technologies.
New systems presented by Roche include a new standard for immunology testing, an integrated platform for hematology diagnostics, and a high-throughput analyzer to perform HbA1c tests for blood glucose management. Also, evidence was presented for a high-sensitivity cardiac troponin test to provide earlier and more accurate diagnosis of heart attacks.
“Diagnostics have proven to be one of the most influential elements in the healthcare value cycle,” says Jean-Claude Gottraux, head of Roche Professional Diagnostics. New members of the cobas family were introduced: cobas e 801 module, cobas m 511 analyzer, and cobas c 513 analyzer. The cobas e 801 module for immunology testing is a platform capable of carrying out double the number of tests compared to the previous version (cobas e 602). The system requires smaller blood samples, making it particularly suitable for diagnosis of vulnerable groups such as neonates, cancer and ICU patients, and elderly people. The reduced sample volume also leads to less liquid waste, thereby decreasing environmental impact. Commercial availability is planned for 2016.
The cobas m 511 integrated hematology analyzer has the potential to transform hematology testing practices. It integrates 3 instruments into one efficient system, enabling labs to save space, time, and money. With a low required blood volume of 30 microliters for a complete hematology result including morphology assessment, cobas m 511 is also suitable for patients where blood volumes are particularly precious. The system is scheduled for launch in 2016.
The cobas c 513 blood glucose analyzer is a dedicated, high-throughput HbA1c analyzer uniquely suitable for diagnosis, monitoring, and risk identification of diabetes patients. It sets new standards of lab efficiency as well as safety for lab personnel. The analyzer is scheduled for commercial availability in Q4-2015.
In cardiovascular testing, Roche has demonstrated the impact of improved troponin testing to detect more heart attacks (acute myocardial infarctions (AMIs)). Roche’s Elecsys cardiac Troponin T – high-sensitive (cTnT-hs) test detects cardiac troponin. In combination with electrocardiogram (ECG), troponin tests have become the gold standard for AMI diagnosis. “With previous generations of troponin tests, the time to diagnose AMI was 6 hours, which has been brought down to 3 hours,” said Christian Mueller, professor of cardiology at the University of Basel, Switzerland, “Increasing evidence shows that the time needed to make decisions in cases of suspected AMI can be further brought down to just 1 hour.” Used in conjunction with a novel approach for result interpretation, the high sensitivity of Roche’s cTnT-hs assay helps reduce time-to-diagnosis to 1 hour. Every hour saved is of critical importance for patients, and faster, more accurate diagnosis is beneficial to the healthcare system overall as patients with symptoms suggestive of AMI account for approximately 10%–20% of all emergency room consultations.
