Site Development and Facility Expansion Regularly Assistance Program, November 1, 2006

The Iowa Department of Economic Development (IDED) helps businesses expand or locate all or part of their business in Iowa. It just makes sense for companies engaged in advanced manufacturing, biosciences and information solutions/financial services to look at Iowa and IDED helps to ensure theireconomic development timelines are met. Iowa is nationally recognized as an innovator in helping businesses by meeting their development needs in a timely and effective manner. IDED networks with Regulatory Assistance Coordinators in agencies across state government to reduce response time to businesses. This agency coordination helps to ensure that regulatory and compliance questions, or other needs associated with project site development and facility expansion are serviced quickly. We have listed information below about some of the more common regulatory requirements related to site development and expansion.

Test of four colon cancer risk-scores in formalin fixed paraffin embedded microarray gene expression data.

BACKGROUND: Prognosis prediction for resected primary colon cancer is based on the T-stage Node Metastasis (TNM) staging system. We investigated if four well-documented gene expression risk scores can improve patient stratification. METHODS: Microarray-based versions of risk-scores were applied to a large independent cohort of 688 stage II/III tumors from the PETACC-3 trial. Prognostic value for relapse-free survival (RFS), survival after relapse (SAR), and overall survival (OS) was assessed by regression analysis. To assess improvement over a reference, prognostic model was assessed with the area under curve (AUC) of receiver operating characteristic (ROC) curves. All statistical tests were two-sided, except the AUC increase. RESULTS: All four risk scores (RSs) showed a statistically significant association (single-test, P < .0167) with OS or RFS in univariate models, but with HRs below 1.38 per interquartile range. Three scores were predictors of shorter RFS, one of shorter SAR. Each RS could only marginally improve an RFS or OS model with the known factors T-stage, N-stage, and microsatellite instability (MSI) status (AUC gains < 0.025 units). The pairwise interscore discordance was never high (maximal Spearman correlation = 0.563) A combined score showed a trend to higher prognostic value and higher AUC increase for OS (HR = 1.74, 95% confidence interval [CI] = 1.44 to 2.10, P < .001, AUC from 0.6918 to 0.7321) and RFS (HR = 1.56, 95% CI = 1.33 to 1.84, P < .001, AUC from 0.6723 to 0.6945) than any single score. CONCLUSIONS: The four tested gene expression-based risk scores provide prognostic information but contribute only marginally to improving models based on established risk factors. A combination of the risk scores might provide more robust information. Predictors of RFS and SAR might need to be different.

HIERFSTAT, a package for R to compute and test hierarchical F-statistics

The package HIERFSTAT for the statistical software R, created by the R Development Core Team, allows the estimate of hierarchical F-statistics from a hierarchy with any numbers of levels. In addition, it allows testing the statistical significance of population differentiation for these different levels, using a generalized likelihood-ratio test. The package HIERFSTAT is available at http://www.unil.ch/popgen/softwares/hierfstat.htm.

Altered vision during motion: an unusual symptom of cerebellar dysfunction, quantifiable by a simple clinical test.

PURPOSE: To report a series of patients with cerebellar dysfunction and altered vision during motion, and to quantify their visual impairment in motion with a simple clinical test. METHODS: Twenty consecutive patients suffering from cerebellar dysfunction and altered vision during motion were examined between 1994 and 2007. A control group consisted of 20 age- and sex-matched healthy people. All patients had a full neuro-ophthalmic examination. Near visual acuity (NVA) was measured at rest (static NVA) and during chair rotation (dynamic NVA). Distance visual acuity (DVA) was measured at rest (static DVA) and during rotation of the patient's head (dynamic DVA). RESULTS: Only four of the 20 patients reported altered vision during motion spontaneously. The remaining 16 patients admitted this unusual visual disturbance only when asked specifically. All patients exhibited abnormal eye movements, including saccadic smooth pursuit (20/20), dysmetric saccades (15/20), nystagmus (19/20) and impaired suppression of vestibulo-ocular reflex (VOR) (20/20). During rotation of the examination chair (dynamic NVA), the drop in NVA averaged 5.6 lines (range 1-10 lines). During rotation of the patient's head (dynamic DVA), the drop in DVA averaged only 2.5 lines (range 0-10 lines). For the control group, there was no significant drop in NVA under dynamic conditions. CONCLUSION: Patients with cerebellar dysfunction rarely complain spontaneously of altered vision during motion. However, specific questioning may bring up this unusual symptom. The use of a simple clinical test, consisting of NVA measurement during rotation of the examination chair (dynamic NVA), allows practitioners to quantify the level of visual impairment in patients presenting altered VOR modulation.

Cost-effective utilization of a private facility to perform outpatient surgery in public hospital waiting list patients.

Background: Public hospitals' long waiting lists make outpatient surgery in private facilities very attractive provided a standardized protocol is applied. The aim of this study was to assess this kind of innovative collaboration in abdominal surgery from a clinical and economical perspective. Methods: All consecutive patients operated on in an outpatient basis in a private facility by a public hospital abdominal surgeon and an assistant over a 5-year period (2004-2009) were included. Clinical assessment was carried out from patients' charts and satisfaction questionnaire, and economic assessment from the comparison between the surgeons' charges paid by the private facility and the surgeons' hospital salaries during the days devoted to surgery at the private facility. Results: Over the 5 years, 602 operative procedures were carried out during 190 operative days. All patients could be discharged the same day and only 1% of minor complications occurred. The patients' satisfaction was 98%. The balance between the surgeons' charges paid by the private facility and their hospital salary costs was positive by 25.8% for the senior surgeon and 12.6% for the assistant or, on average, 21.9% for both. Conclusion: Collaboration between an overloaded university hospital surgery department and a private surgical facility was successful, effective, safe, and cost-effective. It could be extended to other surgical specialities. Copyright (C) 2011 S. Karger AG, Basel

A new blood-based screening test for colorectal cancer: a pilot study

Background: Colorectal cancer (CRC) can be cured when diagnosed in its early or precancerous (adenoma) stages. Mostly due to poor compliance towards invasive screening procedures, detection rates for adenoma and early CRCs are still low. Available non-invasive screening tests have unfortunately low sensitivity and specificity performances. Therefore, there is a large unmet need calling for a cost-effective, reliable and non-invasive test to screen for early neoplastic and pre-neoplastic lesions. Objective: To develop a routine screening test based on a nucleic acids multi-gene assay performed on peripheral blood mononuclear cells (PBMCs) that can detect early CRCs and adenomas. Methods: 116 patients (mean age: 55 years; range: 18 to 74 years; female/male ration 0.98) were included in this pilot, nonblinded, colonoscopy-controlled study. Colonoscopy revealed 21 patients with CRC, 30 patients with adenoma bigger than 1 cm, 24 patients with inflammatory bowel disease (IBD) and 41 patients had no neoplastic or inflammatory lesions. Blood samples were taken from each patient the day of the colonoscopy and PBMCs were purified. Total RNA was extracted following standard procedures. Multiplex RT-qPCR was applied on 92 different candidate biomarkers. Different univariate and multivariate statistical methods were applied on these candidates, and among them, 57 biomarkers with significant p values (<0.01, Wilcoxon test) were selected, including ADAMTS1, MMP9, CXCL10, CXCR4, VEGFA and CDH1. Two distinct biomarker signatures are used to separate patients without neoplastic lesion from those with cancer (named COLOX 1 test), respectively from those with adenoma (named COLOX 2 test). Result: COLOX 1 and 2 tests have successfully separated patients without neoplastic lesion from those with CRC (sensitivity 70%, specificity 90%, AUC 0.88), respectively from those with adenoma bigger than 1cm (sensitivity 61%, specificity 80%, AUC 0.80). 6/24 patients in the IBD group have a positive COLOX 1 test. Conclusion: These two COLOX tests demonstrated an acceptable sensitivity and a high specificity to detect the presence of CRCs and adenomas bigger than 1 cm. The false positives COLOX 1 test in IBD patients could possibly be due to the chronic inflammatory state. A prospective, multicenter, pivotal study is underway in order to confirm these promising results in a larger cohort.

Department of Commerce, Clarinda Correctional Facility FY2007

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, Clarinda Correctional Facility FY2008

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, Fort Dodge Correctional Facility FY2007

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, Fort Dodge Correctional Facility FY2008

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, Mount Pleasant Correctional Facility, FY 2007

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, Mount Pleasant Correctional Facility, FY 2008

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, North Central Correctional Facility, FY 2007

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, North Central Correctional Facility, FY 2008

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.

Department of Commerce, Newton Correctional Facility, FY 2007

These Facts sheets have been developed to provide a multitude of information about executive branch agencies/departments on a single sheet of paper. The Facts provides general information, contact information, workforce data, leave & benefits information, and affirmative action data. This is the most recent update of information for the fiscal year 2007.