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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Mobile DNA Testing Van Cruises New York City Streets and Asks “Who’s Your Daddy?”

Mobile testing truck makes DNA testing approachable and accessible to the community while competing with established clinical laboratories

You may have seen recent news coverage of a van cruising the streets of New York City that was offering on-the-spot DNA testing with signs plastered on sides reading “Who’s Your Daddy”—“DNA Testing.” Certainlyany passing pathologist or clinical chemist might do a double take.

According to abc News coverage of the story, passersby can hail the 28-foot recreational vehicle to have their DNA tested. Of course, no testing is performed in the mobile van. Rather, a technician collects a sample from the customer, packages it, and sends it to a laboratory in Ohio for testing. Results come back in three to five days. Prices for the testing service start at $299. (more…)

Clinical Pathology Laboratories Should Be Aware of New Malpractice Risks from Genetic Testing

Some medical laboratories may be exposed to malpractice suits involving prenatal genetic testing associated with “wrongful birth” claims

Genetic testing is creating a new source of medical malpractice liability and early cases have generated substantial settlements for the plaintiffs. Any clinical laboratory organization or pathologist involved in genetic testing should pay serious attention to this emerging field of malpractice law.

In particular, the media is reporting on malpractice lawsuits that involve prenatal genetic testing that was performed on behalf of parents who were attempting to determine the possibility of serious inheritable diseases in their unborn children.

In these cases, parents of a child born with a debilitating—and frequently financially-devastating—disease that could have been detected by accurate genetic testing are suing their healthcare providers, including medical laboratories. These plaintiffs claim that, through inaccurate genetic testing or lack of available testing, they were denied the choice of terminating a pregnancy that tested positive for serious inherited disease. (more…)

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.
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