Stephen Rusckowski will be the new Quest Diagnostics CEO and president, reports The Wall Street Journal. This, the Journal notes, ends a six-month search for current CEO Surya Mohapatra's successor. Rusckowski has served as CEO of Philips Healthcare, which is part of Royal Philips. Under Rusckowski, Philips Healthcare's revenue increased by $11.8 billion, the Journal adds. Art Henderson, a healthcare analyst at Jefferies & Co. tells the Journal that Rusckowski "is obviously somebody who was pretty instrumental in the growth at Philips." Additionally, Daniel Stanzione will be Quest's new non-executive chairman.

A new study published in Health Affairs by Georgetown University public policy professor Jean Mitchell shows that the practice of physician self-referral for imaging and pathology services is linked to increased utilization and higher spending, but lower rates of cancer detection, according to a release from the College of American Pathologists. "Self-referring urologists billed Medicare for nearly 75 percent more anatomic pathology specimens compared to non self-referring physicians," CAP says. "Furthermore … the [cancer] detection rate was 14 percent lower than that of non self-referring physicians." These findings should raise red flags about self-referral, says CAP President Stanley Robboy. "This analysis also supports the College's long-standing position that self-referral of anatomic pathology services needs to end by removing anatomic pathology from the exception in the Stark Law," CAP adds.

In Modern Pathology, Oslo University Hospital's David Warren and his colleagues report that the molecular markers DDIT3, STT3A, ARG2 and FAM129A are not useful for diagnosing thyroid follicular tumors. The markers had previously been shown to be able to distinguish follicular carcinoma and follicular adenoma, and Warren and his team aimed to verify the predictive accuracy of these makers. To do so, they conducted a retrospective study of protein expression of those follicular carcinomas, follicular adenomas, and controls. "Regrettably, using both immunohistochemistry and western blotting, we demonstrate that these markers are not useful for this purpose," Warren and his team write. "The reasons for the discordance between our results and those of Cerutti et al are, at present, and despite considerable focus on quality assurance of all steps, unknown."

Also in Modern Pathology, the National Cancer Institute's Sinchita Roy Chowdhuri and colleagues examine the use of laser capture microdissection to isolate tumor cells from primary or metastatic lung adenocarcinoma, to detect EGFR and KRAS mutations in formalin-fixed, paraffin-embedded tissues. Chowdhuri et al. found that "laser capture microdissection-enabled mutation detection on cytologic material provides highly accurate and reproducible data comparable or superior to standard methods, and could be invaluable particularly when the tumor sample is limited."

Researchers led by Keio University School of Medicine's Yuhei Koyama report in Clinical Chemistry on their two-step biochemical method to differentially diagnose classic 21-hydroxylase deficiency and cytochrome P450 oxidoreductase deficiency, both of which are marked by high concentrations of 17α-hydroxyprogesterone in the blood. The researchers examined 29 infants' urinary steroid profile using GC/MS,and found that a specific ratio of pregnanetriolone to cortisol metabolites 5α- and 5β-tetrahydrocortisone could distinguish 21-hydroxylase deficiency and cytochrome P450 oxidoreductase deficiency from 17α-hydroxyprogesteronemia. In addition, a cut off for 11β-hydroxyandrosterone could differentiate classic 21-hydroxylase deficiency from P450 oxidoreductase deficiency.

As they report in an online early article at Clinical Chemistry, University of Utah School of Medicine's Kathy Swoboda and colleagues developed a screening assay to test newborns for spinal muscular atrophy. The assay takes advantage of the different melt profiles between wild type SMN1 regions and those with homozygous exon 7 deletions. The researchers report that they could detect all samples with homozygous deletions without any false positives in their test set. "A prospective SMA-screening pilot project to be initiated in 2012 will assess 400,000 newborns," the researchers add. "In the course of that project, we will accurately determine sensitivity, specificity, positive predictive value, and negative predictive value."

In the Journal of Molecular Diagnostics, researchers from Brown University report a novel method for detecting nucleic acid targets using a ligation step and an isothermal, exponential amplification step. "We use an engineered ssDNA with two variable regions on the ends, allowing us to design the probe for optimal reaction kinetics and primer binding," the authors write. "This two-part probe is ligated by T4 DNA ligase only when both parts bind adjacently to the target. The assay demonstrates that the expected 72-nt RNA product appears only when the synthetic target, T4 ligase, and both probe fragments are present during the ligation step." The team also found 40 mmol/L KCl in the final amplification mix to be optimal, and that increasing P5 in excess of P3 reduced the amount of extraneous 38-nt RNA product. "We believe that this method can be used effectively for a number of diagnostic assays," they add.

Also in the Journal of Molecular Diagnostics, a team of researchers from South Korea has developed a DNA methylation marker panel for the diagnosis of extrahepatic cholangiocarcinoma in bile fluids. The team investigated the methylation status of 59 DNA methylation markers in 20 EHC and 20 non-neoplastic gallbladder tissue samples, and selected a panel of markers that showed a sensitivity of 60 percent or more, and a specificity of 100 percent. "Using bile fluids, a methylation assay consisting of a five-gene panel may be useful for detecting EHC and in helping to increase the sensitivity of preoperative diagnoses," they write.

New York State has approved the use of ColonSentry, a colon cancer risk assessment test developed by GeneNews, reports General Surgery News. ColonSentry measures seven RNA biomarkers in blood to assess risk and patients found to have a higher risk of colon cancer could be recommended to have a colonoscopy. However, Memorial Sloan-Kettering Cancer Center's Sidney Winawer tells General Surgery News that the test is not ready for the clinic. "We have [been] down this road before with blood-based markers," Winawer says. "A screening test needs to be shown to detect early curable cancers to be effective. Detecting late-stage cancers is of no benefit."

David Goldberg, the interim president of Enzo Clinical Labs, says that ColonSentry is actually not a screening test, but assesses risk. "What ColonSentry is designed for is to give primary care physicians a tool [with] which to help assure compliance with regular colonoscopy screening," Goldberg tells General Surgery News.