Roche Gains First FDA Approval Of HbA1c Assay As Diabetes Diagnostic


Espicom View: With Abbott hot on Roche's heels with an assay for the diagnosis of diabetes, Roche has made it to the US market first. This latest approval will boost the flagging sales of Roche's Diabetes Care unit within its Diagnostics division. Being first to the US market will help to ensure Roche maintains its leading position within in vitro diagnostics. However, Abbott has filed for approval of its own HbA1c assay for diagnosis with the FDA and has already received CE mark approval, attempting to close the gap on Roche.

Roche has gained the first FDA approval of an HbA1cDx assay to be used in the diagnosis of diabetes rather than the monitoring of blood glucose levels. The FDA has allowed the marketing of the company's cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by healthcare professionals. This is the first HbA1c test that the FDA has allowed to be marketed for this use. HbA1c tests currently on the market are FDA-cleared for monitoring a patient’s blood glucose control, but not for diagnosing diabetes.

Diabetes Care accounted for 25 per cent of Roche's Diagnostic revenue in 2012; revenue generated by this unit declined by approximately 4 per cent compared with the previous year. The company cites reimbursement cuts for blood glucose monitoring products in Europe and pricing pressures as the main reason for this decrease. Roche claims to be the industry leader with a 31 per cent market share of a global blood glucose monitoring market, which is worth over US$8 billion. The company's competitors include LifeScan (a Johnson & Johnson company) with a 26.3 per cent market share; Abbott with 14.5 per cent; and Bayer with 14.1 per cent. This new approval has the potential to lift US sales for Roche and bring the Diabetes Care business unit back to growth, maintaining the company's leadership position.

The FDA estimates that 25.8 million people in the US have diabetes, including 7 million people who remain undiagnosed. Business Monitor International's Burden of Disease Database estimates that the number of disability-adjusted life years (DALYs) lost to diabetes in the US totalled 2.5 million in 2012 and is estimated to reach 3.1 million in 2020. According to Abbott, in 2012, US$471 billion was spent globally as a result of diabetes. Roche is already a player in this lucrative field with pharmaceuticals, monitoring equipment and other diabetes related products. The addition of the HbA1c test to an extensive range of diabetes products will help the company with any flagging sales seen in this arena. Being the first company with an approval in the US for this type of assay for diagnosis will benefit Roche.

The diagnostic criteria for diabetes have changed over time. In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of Type II diabetes and identification of patients at risk for developing diabetes if the assay meets specific performance criteria, such as certification and standardisation processes outlined by the National Glycohemoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry. Based on the research and recommendations of international diabetes experts, many healthcare providers have already been using some HbA1c tests to diagnose diabetes, in addition to the established diagnostic procedures of a fasting blood glucose test and an oral glucose tolerance test to diagnose diabetes. However, before this approval, HbA1c tests were not specifically designed or granted permission by FDA to be marketed for diabetes diagnosis, making it difficult to know which tests were accurate enough for this purpose. The Tina-quant HbA1cDx assay, a laboratory-based test, can be used to both accurately diagnose diabetes and monitor blood glucose control.

In support of marketing clearance, investigators analysed 141 blood samples and found less than 6 per cent difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared to results from the standard reference for haemoglobin analysis.

Earlier in May, Abbott received the CE mark for its HbA1c test on the architect system for the diagnosing and monitoring of diabetes. The company has also recently filed for marketing clearance with the FDA. The test was originally approved for the monitoring of glucose levels in July 2012. Roche claims that it has a 20 per cent share, and Abbott has an 11 per cent share, of the global in vitro diagnostic market, which is valued at US$44 billion in annual sales. Roche is still far ahead of Abbott in terms of market share, but Abbott has the potential to gain ground on its competitor.