Despite launching years after the next-generation sequencing systems from Illumina and Thermo Fisher, officials at the German molecular biology company Qiagen see an opening for their GeneReader NGS offering.

“Labs struggle with NGS adoption, whether it’s with fragmented workflows or the technical challenges,” says Jonathan Arnold, senior director of marketing at Qiagen, whose North American headquarters are in Germantown, Md. “We’re not launching a sequencer or a box, but launching a complete solution in itself.”

The lead item in  the December “Put It on the Board” section  of CAP TODAY.  Read the whole shebang.

The final Medicare physician fee schedule for 2016 delivered on the Centers for Medicare and Medicaid Services’ July proposal of an overall increase in payment for pathologists and independent laboratories. The agency also fulfilled some pathologists’ fears by cutting payments for prostate biopsy services by 19 percent for the technical component and 18 percent for the global payment.

When a relatively good year on the Medicare pay side means treading water, laboratory consultants say it is all the more imperative for pathology groups to get the most out of their negotiations with private payers, hospitals, or accountable care organizations.

In the December CAP TODAY. Read the whole shebang.

In 2010, the American Diabetes Association endorsed the use of hemoglobin A1c to diagnose type 2 diabetes, and fierce arguments over the wisdom of that move have ensued ever since. A 2013 debate at the American Association for Clinical Chemistry’s annual meeting featured a spirited dialogue on the merits of using HbA1c as a diagnostic marker, compared with the traditional—and still ADA-recommended—alternatives, fasting plasma glucose and two-hour plasma glucose.

Now the discussion is zeroing in on a narrower controversy within the HbA1c dispute—the role of race and ethnicity. African-Americans regularly have higher HbA1c values than do whites, even when they have similar fasting plasma glucose levels. Hispanics, too, have exhibited a similar HbA1c/FPG disparity, though amid a smaller body of research and to a lesser degree than is found among blacks. The questions are what this widely observed trend means and what to do about it.

Do higher HbA1c concentrations among blacks and Hispanics reflect socioeconomic or lifestyle factors, or are they driven by some as yet unidentified molecular or biological nonglycemic factors present in these patient populations? Should clinicians and laboratories set different diagnostic cutpoints for their black and Hispanic patients than for their white ones? Should laboratories seek race and ethnicity data to help overcome this apparent impediment to HbA1c interpretation?

My  cover story  in the December issue of CAP TODAY. Read the whole shebang.