The Association for Molecular Pathology has published a 14-page report its leaders hope will reset the conversation payers, policymakers, and medical guideline panels have when assessing the clinical utility of molecular diagnostics in oncology and inherited diseases. The key to AMP’s approach is to broaden the standard for what is considered a clinically useful molecular diagnostic test.

“We tried to take an inclusive approach and look at patients, providers, and clinicians, and we tried to address clinical utility from all those standpoints,” says Elaine Lyon, PhD, co-chair of the AMP Framework for the Evidence Needed to Demonstrate Clinical Utility Task Force. The panel met for two years to develop the document, “The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology” (Joseph L, et al. J Mol Diagn. 2016;18[5]:605–619).

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When nephrologist Katherine Tuttle, MD, first saw the photo of two women holding young children, she thought it captured the mother of the boy and girl sitting on a couch with the children’s grandmother.

The younger-looking woman, 33 at the time the photo was taken, works in the clinical research group at Providence Health Care, Spokane, Wash., where Dr. Tuttle is executive director for research. Flashing a smile in the photo, Dr. Tuttle’s colleague held in her arms a baby girl who munched on her toy. Seated next to her was a woman whom diabetologists would recognize as having lost sight in one eye, with a two-year-old boy on her lap. Her face, deeply lined with wrinkles, bore a glum expression.

Contrary to Dr. Tuttle’s first impression, that second woman was no grandmother. She, too, was 33 years old, a cousin of Dr. Tuttle’s colleague and the mother of the two-year-old boy. Diagnosed with type 1 diabetes at 12, she had been on hemodialysis for two years by the point the photo was taken and had lost vascular access. Due to her son’s birth, the woman was highly sensitized and no kidney donor could be found.

“She was dialyzing via a hemodialysis catheter, and if you are a nephrologist you’d say she was probably not receiving very good dialysis based on the way she looked,” Dr. Tuttle said during a talk at the American Association for Clinical Chemistry’s annual meeting in August. “She had been thinking about stopping dialysis, but she didn’t have to make that choice because she was found dead about six weeks after this picture was taken.”

“This is what youth-onset diabetes looks like by the 30s, when people are supposed to be enjoying the prime of life,” she added. “It doesn’t matter if you’re type 1 or 2. It doesn’t matter what color you are. It’s really tragic, and it should be preventable.”

But preventing kidney failure requires new therapies and better biomarkers to help develop, test, and monitor the effect of those treatments. Slashing the rates at which patients with diabetes develop and die of kidney disease also depends on improved clinical use of existing tests and standardization of urine albumin and the cystatin C-based estimate of glomerular filtration rate, said Dr. Tuttle and her co-panelists during the AACC session, “Diabetic Nephropathy: Where Are We Now?”

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