The Observatory

Aug. 2, 2015


Bacteria may be a cause of type 2 diabetes. Researchers have found that prolonged exposure to a toxin produced by Staphylococcus aureus bacteria causes rabbits to develop the hallmark symptoms of type 2 diabetes, including insulin resistance, glucose intolerance, and systemic inflammation. Obesity is a known risk factor for developing type 2 diabetes, but obesity also alters a person’s microbiome—the ecosystem of bacteria that colonize our bodies and affect our health.

The study, published recently in the journal mBio, shows that superantigens interact with fat cells and the immune system to cause chronic systemic inflammation, and this inflammation leads to insulin resistance and other symptoms characteristic of type 2 diabetes. In examining the levels of staph colonization on the skin of four patients with diabetes, the researchers estimate that exposure to the bacterial superantigens for people who are heavily colonized by staph is proportional to the doses of superantigen that caused the rabbits to develop diabetes symptoms in the team’s experiments.

Alzheimer’s Disease

Specialized proteins may be detected in blood of people with Alzheimer’s. Specialized brain proteins that are involved in the removal of damaged nerve cell materials may be detected in the blood of people who were diagnosed with mild cognitive impairment or dementia due to Alzheimer’s disease. In a select group of people who later developed dementia, the levels of the lysosomal proteins were abnormal while the individuals still had no problems with memory or thinking skills, according to a study published online in Neurology.

The researchers looked at four proteins in blood exosomes that come from lysosomes. Lysosomes act as a sort of recycling and disposal center for cells. In each case, the level of protein was significantly different for the healthy controls than for those with dementia—both before and after symptoms developed. For three of the proteins, the people with dementia had significantly higher levels; for one, the people with dementia had significantly lower levels.


New biomarker identified in women with mental illness. Psychiatric disorders can be difficult to diagnose because clinicians must rely upon interpreted clues, such as a patient’s behaviors and feelings. Now, researchers at University of California, San Diego School of Medicine report identifying a biological marker: the over-production of specific genes that could be a diagnostic indicator of mental illness in female psychiatric patients.

Researchers found that the gene XIST, which is responsible for inactivating one of the two copies of the X chromosome in cells that store genetic material, works overtime in female patients with mental illnesses such as bipolar disorder, major depression, and schizophrenia.

The study suggests that over-production of XIST and genes from the inactive X chromosome are common denominators in the development of psychiatric disorders in patients with rare chromosome disorders, such as Klinefelter syndrome and Triple X syndrome, and in the general population of female psychiatric patients.

The study was conducted on 60 lymphoblastoid cell lines from female patients, most of whom had a family history of mental illness. Approximately 50 percent of the female patients exhibited abnormally high levels of XIST and other genes related to the X chromosome.

The researchers say that reversing the abnormal activity of the inactive X chromosome in patients suffering from mental illness may offer a potential new strategy for treating psychiatric disorders.


DNA shed from head and neck tumors detected in blood and saliva. Seeking better cancer screening tests, Johns Hopkins scientists led a proof of principle study that successfully identified tumor DNA shed into the blood and saliva of 93 patients with head and neck cancer.

In the case of head and neck cancers associated with HPV, the scientists searched patients’ blood and saliva samples for certain tumor-promoting HPV-related DNA. For non-HPV-related cancers, which account for the majority of head and neck tumors, they looked for mutations in cancer-related genes that included TP53, PIK3CA, CDKN2A, FBXW7, HRAS, and NRAS.

When the scientists analyzed how well their tumor DNA tests found cancers in certain regions of the head and neck, they found that saliva tests fared better than blood tests for oral cavity cancers. Blood tests correctly identified tumor DNA more often in oropharynx cancers, larynx cancers, and hypopharynx cancers. Taken together, blood and saliva tests correctly identified all oral cavity, larynx, and hypopharynx cancers and 20 of 22 oropharynx cancers.

Industry News

FDA draft guidance covers direct marking of devices with identifiers. The U.S. Food and Drug Administration (FDA) has released draft guidance on the agency’s requirements for direct marking of medical devices with a unique device identifier (UDI). When finalized, this draft document will assist industry, particularly labelers, as defined under 21 CFR 801.3, and FDA staff in understanding FDA’s requirements for direct marking of devices for unique device identification purposes.

Under 21 CFR 801.45, “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”

This draft guidance defines some terms used in the Agency’s regulations pertaining to the UDI direct marking requirements, including how FDA interprets the term “reprocessed” as used in 21 CFR 801.45. For additional background on the UDI system, see the UDI System Final Rule, published on September 24, 2013 (78 FR 116 58786) (the UDI Rule).

A Food and Drug Administration final rule in 2013 on UDIs noted that direct marking requirements apply to devices that are intended to be used for months or years, sometimes many years, the agency said in a notice published June 26. “Because such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages,” the agency notice said, adding that direct marking helps to ensure the adequate identification of such devices through their distribution and use.


TELCOR executive weighs in on the future of point-of-care testing. Becky Clarke, Executive Vice President, Point-of-Care, for Lincoln, Nebraska-based TELCOR Corporation, kindly accepted an invitation from the editors of MLO to consider for readers the future of POCT. Alas, we didn’t have room on pages 26 and 27, the home this month for contibutions on that topic—so we are pleased to print her valuable and lively contribution right here.

Oh, the places it is going…POCT, that is! As technologies advance, testing menus expand, EMR implementations increase, organizations continue to consolidate, and we actively take more control of our wellness, point-of-care programs see the opportunity and need to better manage the implementation of laboratory testing at the ambulatory setting. In order to evaluate the efficacy of ambulatory testing, ask yourself these questions:

  1. Do we have testing devices that connect and electronically send results
  2. Do we have testing devices that provide QC and operator lockout?
  3. Do we have testing devices capable of receiving electronic operator lists from centralized systems to eliminate the manual addition and deletion of operators from the testing devices?
  4. Do we have a process or system for documentation of manual testing that provides us with the appropriate testing information?
  5. Do we have a process whereby we can obtain operator competencies that can be used in addition to the number of tests they performed to complete our testing compliance?

When you have a centralized point-of-care system that can positively address all of these questions…oh, the places it will seamlessly go!

Infectious Disease

Hospital readmissions for sepsis are highly common, extremely costly. The Affordable Care Act created several national initiatives aimed at reducing hospital readmission rates for heart attacks, congestive heart failure, and other common high-risk conditions. But there is still no national program intended to address sepsis. Now, a new UCLA study has found that sepsis accounts for roughly the same percentage of hospital readmissions in California as heart attacks and congestive heart failure—and that it costs the healthcare system more than both of them combined.

The research, conducted by the UCLA Clinical and Translational Science Institute, is published online in the journal Critical Care Medicine.

“Our study shows how common sepsis readmissions are and some of the factors that are associated with higher risk of readmission after these severe infections,” said Dong Chang, MD, assistant professor of medicine at Harbor–UCLA Medical Center and the study’s lead author. “In addition, we show that sepsis readmissions have a significant impact on healthcare expenditures relative to other high-risk conditions that are receiving active attention and interventions.

“Based on these results, we believe that sepsis readmissions are under-recognized and should be among the conditions that are targeted for intervention by policymakers.”

The researchers analyzed admissions for adults 18 and older for sepsis at all California hospitals from 2009 through 2011, and during the same period for congestive heart failure and heart attacks. There were a total of 240,198 admissions for sepsis, 193,153 for congestive heart failure, and 105,684 for heart attacks.

They found that the all-cause 30-day readmission rate for sepsis was 20.4 percent. The rates for congestive heart failure and heart attacks were 23.6 percent and 17.7 percent, respectively. The study found that people with sepsis were readmitted because of respiratory failure; pneumonia; complications with devices, implants or grafts; urinary tract infections; renal infections; renal failure; and intestinal infections; among other causes.


CMS and AMA announce efforts to help providers get ready for ICD-10. With less than three months remaining until the nation switches from ICD-9 to ICD-10 coding for medical diagnoses and inpatient hospital procedures, the Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA) are announcing efforts to continue to help physicians get ready ahead of the October 1 deadline. CMS is releasing additional guidance that will allow for flexibility in the claims auditing and quality reporting process as the medical community gains experience using the new ICD-10 code set.

Recognizing that healthcare providers need help with the transition, CMS and AMA are working to make sure physicians and other providers are ready ahead of the transition to ICD-10. Reaching out to healthcare providers all across the country, CMS and AMA will in parallel be educating providers through webinars, on-site training, educational articles, and national provider calls to help physicians and other healthcare providers learn about the updated codes and prepare for the transition.

The International Classification of Diseases, or ICD, is used to standardize codes for medical conditions and procedures. The use of ICD-10 should advance public health research and emergency response through detection of disease outbreaks and adverse drug events and support innovative payment models that drive quality of care.


Please note the following correction/clarification of a passage in the June 2015 Continuing Education article entitled, “HPLC: its continuing role in diabetes monitoring.” The relevant passage is on page 9 of the print edition.

Statement currently in article: According to NGSP, “Only HPLC utilizing ion-exchange chromatography measures HbA1c. Affinity columns measure any hemoglobin that has glucose attached regardless of its attachment point or its structure because the column binds the glucose portion of the molecule. Any variant hemoglobin that is present will be detected as glycated products.”16 Reference: 16. NGSP, HbA1c assay interferences. Updated Sept. 2014.

Replacement statement: According to NGSP, “Laboratories use many different methods for measuring A1C, but some of these methods can give inaccurate results when the patient has a hemoglobin variant such as sickle cell trait or if there is an elevated level of fetal hemoglobin (HbF). Doctors or patients interested in getting information about the accuracy of a particular A1C method for patients with hemoglobin variants should first find out which method your laboratory is using.”16 Reference: 16. NGSP, HbA1c assay