With Home HbA1c Testing, Industry Won’t Give Up the Ghost

With Home HbA1c Testing, Industry Won’t Give Up the Ghost

Glycated hemoglobin (HbA1c or simply A1c) is one the greatest clinical and IVD industry success stories of the past decade, but has faltered on one front - home testing or patient self-testing. A seemingly natural extension of self-monitoring of blood glucose (SMBG), the market for CLIA-waived home use HbA1c tests has struggled through significant field testing error (and lot-to-lot variation in studies), limited reimbursement coverage, and a lack of resonance with patients and clinicians. Yet, the product area continues to see industry activity, suggesting some participants are holding out hope for further market development.

HbA1c is a powerful clinical tool for monitoring glycemic control in diabetics, pre-diabetics, and other at-risk patients. Since last year, clinical HbA1c tests have also been FDA-approved for the diagnosis of diabetes. HbA1c tests assay the amount of glucose bound to hemoglobin in red blood cells. With blood cell lifetimes of 120 days, the share of HbA1c out of total hemoglobin provides a metric of patient glycemic control over the past 120 days. Originally, HbA1c testing was performed exclusively in labs using high-performance liquid chromatography (HPLC) able to quantitatively detect different hemoglobin variants such as HbA1c. Lab immunoassay designs incorporating anti-HbA1c antibodies in conjunction with traditional total hemoglobin testing brought the test into POC settings. Metrika - later acquired by Bayer Diabetes Care to form its A1CNow product line - was able to refine the method further and secure CLIA waivers for both professional and prescription home use.

A technological success story since played out in cholesterol, coagulation, and HIV testing, the simplification of the HbA1c test has yet to spawn a significant OTC market. The Centers for Medicare & Medicaid services (CMS) do not reimburse for the provision of home HbA1c test kits (meter disposed of after use with two packaged test cards) and does not reimburse tests performed by anyone except a professional and performed in an office or facility setting. Perhaps in recognition of these limitations, Bayer embarked on a different strategy with its A1CNow products:

The thought was Bayer with their scale… could use the A1CNow as an engagement tool for patients who weren’t testing their glucose or weren’t testing as often as they should. Basically the A1CNow would be the patient’s baby step into testing their glucose on a regular basis. As Diabetic Investor noted on more than one occasion with the proper marketing effort Bayer could have educated patients as to the correlation between regular glucose monitoring and A1C.

The strategy failed to play out. Consumer response was at best mixed with reporteddisrepancies with same-day home and lab HbA1c results (patient use of wet reagents a likely factor). Without reimbursement (except through past manufacturer rebates), diabetics paid for a test otherwise routinely provided with no out-of-pocket cost during routine office visits. The niche market created by A1CNow continued among a small subset of diabetics seeking insight in between their 6-month visits. In terms of accuracy, the A1CNow also failed to match CLIA-waived professional HbA1c analyzers such as Siemens’ DCA Vantage and Alere’s Afinion.

A review of Medicare data shows that an initially rapid growing home HbA1c market stalled and declined between 2007 and 2012: Part B reimbursements for CPT 83037 (professional HbA1c testing using OTC HbA1c meters) slid from $4.6-4.7 million in 2007-2008 to $3.5 million in 2012 (Bayer discontinued its A1CNow product line in 2013). The test service also represented roughly only 2% of the total HbA1c reimbursements. Kalorama Information analysis further concluded that home HbA1c meters were used for roughly only 5% of physician office (POL) HbA1c tests in 2012.

Non-instrument HbA1c tests have so far failed to capture the magic of professional HbA1c and SMBG or OTC glucose markets. However diminished from its earlier perceived potential though, the consumer HbA1c testing market still manages to attract the attention of the IVD industry. Polymer Technology Systems (recently renamed Chek Diagnostics) acquired Bayer’s discontinued A1CNow product line in December 2013. The name change combined with the acquisition prompted a suit by Roche Diagnostics in April 2014 seeking Chek Diagnostics’ abandonment of its new business name and removal of the name from any marketed diabetes care products (Roche markets a leading line of glucose meters under the name Accu Chek). Roche’s scrutiny reflects an enduring industry belief in the marketing and sales synergy between regular SMBG and home HbA1c testing, despite the lack of success under Bayer.

In May 2014, Bio-Rad Laboratories’ CLIA-waived in2it POC HbA1c was re-approved by the FDA for prescription home use. Bio-Rad’s presence in the POC end of HbA1c testing provides at best an ancillary and minor revenue stream in the estimation of Kalorama Information; the company is the clear-cut market leader in laboratory hemoglobin variant testing, earning it many times the amount of business. Since its acquisition of the in2it instrument from Provalis Diagnostics in 2006 for roughly $3 million, Kalorama Information estimates associated revenue for Bio-Rad has appreciated to roughly $6 million - largely through professional testing - or a figure dwarfed by its HPLC HbA1c business.

The greatest potential within the HbA1c test market lies with professional testing; test demand will continue to rise with new utilization as a means of diabetes diagnosis. Home test sales will not be similarly impacted as prescription use and consumer demand will depend upon prior diagnosis. Recent actions by Polymer Technology Systems, Roche and Bio-Rad are likely motivated by the same perspective once shared by Bayer Diabetes Care: a home HbA1c test market can be cultivated leveraging the scale of the global SMBG or OTC glucose market (~$10 billion) rather than the comparatively fledgling OTC cholesterol ($15 million) and HIV test ($10 million) markets.

For an overview of current and future POC IVD markets (including POC markets for HbA1c), consult Kalorama Information’s comprehensive report on the subject.