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Abbott Seeking Broader Adoption of Diabetes Testing With Point-of-Care Technology

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NEW YORK – On the heels of a 510(k) clearance from the US Food and Drug Administration for its point-of-care diabetes diagnostic test, Abbott is embarking on a longer-term strategy to drive greater adoption of HbA1c testing.

The FDA cleared the Afinion HbA1C Dx assay for use on its Afinion 2 and Afinion AS100 analyzers to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients' risk of developing the condition. The Afinion test, the first FDA-cleared rapid point-of-care test in the US to diagnose diabetes, became Abbott's product following its purchase of Alere in 2017.

In the US, the firm currently has regulatory clearance to market the assay in settings that have obtained permission to run tests that are designated as moderately complex, which are often large multiphysician practices and clinics associated with hospitals, Gillian Parker, senior director of the Abbott's cardiometabolic business unit, said in an interview.

Eventually, Abbott anticipates receiving clearance to place the rapid POC test with its desktop-size analyzer in physicians' offices, retails clinics, and other settings that run CLIA-waived tests, Parker said.

Small physician practices normally don't operate tests with moderate complexity status because of the stringent requirements that are required, but a CLIA-waiver, which the firm is pursuing with the FDA, would permit it to market the test to a broad untapped base of clinicians.

"With this 510(k) clearance for diagnostic use, we have taken the first step in that direction," Parker said. "In the US, about 30 million people are living with diabetes and about 7.2 million of them are unaware that they have it, which means that it is going untreated and they are not seeking care that could prevent its progression and development of complications."

When people living with prediabetes are added to those numbers, the prevalence is far higher, and "it is highest in communities with a lower socioeconomic status in which patients frequently don't seek preventive care," Parker said. About 84.1 million people in the US have prediabetes, according to US Centers for Disease Control and Prevention estimates.

Broader access to HbAIc testing could also boost demand for laboratory testing because more patients diagnosed with diabetes could opt to have lab tests for continuous monitoring, Parker said.

"We expect to see overall HbA1c testing increase at the laboratory and at the point-of-care in moderately complex facilities," Parker said. "By expanding access to care, there's a tremendous opportunity to impact people who are living with diabetes, are unaware of it, and are at risk of developing diabetes," Parker said.

Laboratory tests for HbA1c have been around for some time. The FDA cleared a Roche laboratory test for HbA1c testing — the Tina-quant HbA1cDx Gen. 2 assay — in 2013. Since then, the agency has cleared 24 laboratory analyzers and assays for use in diagnosing diabetes, including lab tests marketed by Abbott, Bio-Rad Laboratories, Ortho Clinical Diagnostics, Sebia, Siemens Healthineers, Sekisui Diagnostics, and Danaher's Beckman Coulter, in addition to Roche.

However, the availability of a point-of-care test for HbA1c in addition to lab tests should not only benefit patients, but also help physicians who are managing increasingly overcrowded medical practices, encountering pressure to meet quality metrics, and need to contain costs, Parker said.

"Having the ability to have an informed discussion with your patient immediately with the results in hand is so much more efficient for those physicians," she said.

To illustrate the importance of making available an alternative, more convenient option to laboratory testing, Parker pointed to a study of 186,306 adults with diabetes in Kaiser Permanente Northern California that reported 1 in 7 patients did not complete routine laboratory tests within six months of a provider referral.

The Afinion HbA1c assay delivers accurate and precise HbA1c results in three minutes, enabling clinicians to formulate individual care plans for their patients during a single office visit, Kristian Furuseth, a physician who manages the Solli Clinic in Jessheim, Norway, said in an interview.

Furuseth uses the Afinion HbA1c assay for monitoring and diagnosis at Solli Clinic, a six-physician general practice clinic, and has been a clinical advisor to the Norwegian Diabetes Association since 1998.

The assay has been cleared for monitoring and diagnostic use in European countries for several years with the timing of clearances varying by country and in association with regional regulations, Furuseth said. His clinic runs five Afinion analyzers, using them to measure not only HbA1c but also albumin-to-creatinine ratio to assess kidney health and C-reactive protein levels to test for hypertension.

In addition to its regulatory clearances in Europe, the Afinion HbA1c test was granted FDA clearance as a moderate complexity test for monitoring glycemic control in people with diabetes in 2005 and received a CLIA waiver for monitoring purposes in 2006.

Because the test is simple to use and has been CLIA-waived for monitoring, "we fully anticipate that we will get to our end goal, which is to expand the offering to the CLIA-waived setting," as a diagnostic tool, Parker said.

However, the anticipated timing of receiving clearance is unclear, she noted, and the FDA has stricter performance requirements for point-of-care tests used in diagnosis than in monitoring. The percentage of allowable error, considering all sources of variation in the test, is so tight that central lab systems struggle to hit the allowable error target, she said. In developing the point-of-care assay, "we ensured that we would rival even the best central lab systems in terms of accuracy and precision," Parker said.

The firm is negotiating its first contracts for use of the analyzer in the US to diagnose diabetes. It has already placed 45,000 instruments globally and 22,000 in the US for diabetes monitoring, and sales for that specific use have been growing at a double-digit rate year over year, Parker said.