News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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MinuteClinics and Axis-Shield Ink Agreement to Provide Point-of-Care Hemoglobin A1c Tests in 600 CVS Pharmacies

Retail clinics ready to expand into chronic disease management and that can be a threat or an opportunity for clinical laboratories

Dark Daily has often predicted that rapid clinics in retail stores would actively look for opportunities to add specific medical laboratory tests to their on-site service menus. Now the largest retail clinic in the U.S. is set to deploy hemoglobin A1c (HbA1c) testing analyzers in its 600 retail clinic sites throughout the United States.

This deal was announced in November between MinuteClinic, a division of CVS Caremark Corporation (NYSE:CVS), and Axis-Shield plc (LSE:ASD, OSE:ASD), of Dundee, Scotland. The agreement calls for MinuteClinic to use Axis-Shield’s Afinion analyzer in all 600 of its clinic locations across the nation. The system’s HbA1c assay is CLIA-waived. The fully automated analyzer will allow MinuteClinic’s providers to collect a patient specimen and get the results of the hemoglobin A1c tests in as little as three minutes.

Of course, the business strategy here is to add the clinical services necessary so that providers can serve patients with diabetes in these retail clinic settings. This represents a sizeable market. According to the 2011 National Diabetes Fact Sheet, there are 25.8 million adults and children with diabetes, and only 18.8 million have been diagnosed. Of greater interest for clinical laboratory managers and pathologists, 79 million Americans are considered pre-diabetic and, in 2010, 1.9 million new cases of diabetes were diagnosed among individuals who are 20 years and older.

FDA Gets an Earful During Public Meeting on Guidance Document for IVD-MIAs

Yesterday’s public forum conducted by the Food and Drug Administration (FDA) on proposed guidance to regulate a certain category of molecular diagnostic assays drew a surprisingly large and diverse number of presentations and comments from the laboratory, biotech, and healthcare industries.

When the FDA recently released two draft guidelines, one for commercially distributed analyte specific regents (ASRs) and another for IVD multivariate index assays (IVD-MIAs), it was hoping to address criticisms and claims of confusion. These two draft guidelines were largely the results of complaints that a 1997 FDA rule that defined and classified ASRs, establishing requirements and imposing restrictions, resulted in confusion.

The primary cause of confusion regarding IVD-MIA regulation circulated around IVD-MIAs that were both developed and used by laboratories. This confusion resulted because of FDA regulation of laboratory-developed or “home brew” tests. The draft guidelines from the FDA suggest that IVD-MIAs do not fall within the definition of laboratory-developed tests.

The Office of In Vitro Diagnostic Device Evaluation (OIVD) held a public meeting yesterday, February 8, 2007, to provide a public forum during which OVID heard presentations and comments from interested stakeholders. Dark Daily received the presentation materials from Alan Mertz, President of the American Clinical Laboratory Association, who made the following recommendations to achieve the goal of the Draft Guidance:

• First, ACLA recommends that FDA issue a proposed rule to address this important subject matter through the formal notice and comment rulemaking process rather than through sub-regulatory guidance.

• Second, ACLA recommends that FDA consider proposals to narrow and clarify its definition of IVDMIAs to avoid confusion and unintended consequences.

• Third, ACLA recommends that FDA work with CMS and through HHS to address its concerns through enhancement and better enforcement of the regulations promulgated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

“We appreciate that the FDA arranged the meeting,” said Mertz. “It was clear by the number of presenters how important this issue is to all sectors of healthcare, not just labs. I was struck by the number of concerns expressed about the current draft guidance by such a diverse group of stakeholders. We hope that FDA will take these concerns into full consideration if they choose to move forward.”

The gist of both Mertz’ presentation, and a November/December 2006 article in IVD Technology was that the goal of the draft guidelines was a good one, but the guidelines fall short of what they set out to accomplish. They do not further clarify what constitutes an IVD-MIA. Furthermore, the guidelines’ solution for enforcing these new FDA rules – reliance on complaints originating within the industry- is likely to result in companies turning on each other. That is not likely to serve the public health in an efficient manner.