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Trovagene to Study Trans-Renal KRAS Mutation Detection in Pancreatic Cancer - MarketWatch (press release) |
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SAN DIEGO, July 3, 2012 /PRNewswire via COMTEX/ -- Trovagene, Inc.
/quotes/zigman/10294822/quotes/nls/trov TROV
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, a developer of trans-renal molecular diagnostics, announced today that they will be collaborating with The University of Texas MD Anderson Cancer Center on the detection of transrenal KRAS mutations in the urine of patients with pancreatic cancer.
According to recent estimates KRAS mutations are present in more than 90% of pancreatic cancers (1-3), and in 23% of all cancer tissue samples examined by the Sanger Centre (4). An earlier publication in this field used a complicated two-stage PCR assay to detect KRAS mutations in the urine of patients with pancreatic carcinomas (5). Recently, Trovagene successfully completed the analytical development of digital PCR assays for the detection of the most prevalent KRAS mutations, including ones that account for approximately 95% of the KRAS mutations found in pancreatic adenocarcinomas, the most common form of pancreatic cancer.
Matthew H. Katz, MD, FACS, who will lead the study for MD Anderson, said, "We are pleased to begin this study to detect KRAS mutations in the urine of patients with pancreatic cancer. We will also determine the KRAS mutation status from biopsies taken from the same patients. This will allow an early comparison of mutation detection using biopsy, which samples only a portion of a tumor, with detection using urine, a systemic sampling of the patient."
"The reliable detection and quantification of both KRAS mutations and wild type molecules from urine could eventually lead to a sensitive method for staging tumors before treatment and detecting minimal residual disease after treatment," said Dr. Charlie Rodi, chief technology officer at Trovagene. He added, "The volume of urine that can be collected far outstrips what is available by biopsy or even through blood collection; this may significantly improve detection. In addition, urine is a truly non-invasive sample that could greatly simplify patient monitoring in the future."
Almoguera C, Shibata D, Forrester K, et al. Most human carcinomas of the exocrine pancreas contain mutant c-K-ras genes (1998) Cell 53: 549-554.
Smit V, Boot A, Smits A, et al. KRAS codon 12 mutations occur very frequently in pancreatic adenocarcinomas(1988) NAR 16(16): 7773-7782.
Zhang C, Guo W, Wu J, et al. Differential high-resolution melting analysis for the detection of K-ras codons 12 and 13 mutations in pancreatic cancer (2011) Pancreas 40(8): 1283-1288.
Prevalence of KRAS mutations in various cancers. Sanger COSMIC site.
http://www.sanger.ac.uk/perl/genetics/CGP/cosmic?action=bygene&ln=KRAS&start=1&end=189&coords=AA :AA
Botezatu I, Serdyuk O, Potapova G, et al. Genetic analysis of DNA excreted in urine: a new approach for detecting specific genomic DNA sequences from cells dying in an organism (2000) Clinical Chemistry 46(8): 1078-1084.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine.
Trovagene has a dominant patent position as it relates to transrenal molecular testing. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in CLL (chronic lymphocytic leukemia) patients.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2011 and other periodic reports filed with the Securities and Exchange Commission.
ContactsTrovagene, Inc.Keith McCormickVP, Commercial Operations+1 (858)
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.trovagene.com
SOURCE Trovagene, Inc.
Copyright (C) 2012 PR Newswire. All rights reserved
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Kidney program to go beyond the renal disease prevention month - Philippine Information Agency |
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OZAMIZ CITY, Misamis Occidental, July 3 (PIA) -- The City Health Office (CHO) will continue the advocacy of the Renal Disease Control Program (REDCOP) even beyond the National Kidney Month of June.
This assurance came from Dr. Daniel Medina, CHO Officer, who said the conduct of daily consultations and urinary screening tests (USTs) will go on at the health office for the rest of the year.
Medina said that the theme ”Ikaw at Ako Ay Panalo sa Malusog Na Bato (With Healthy Kidneys, You and I are Winners)" will remain the focus of the intensified campaign to heighten awareness of residents on how to take care of one’s kidneys.
In fact, the information, education, and communication (IEC) campaign that REDCOP did last month will still be discussed during the mothers’ classes and group health teachings in the barangays year-round, and not only during the month of June, Medina said.
He said a total of 770 patients were recommended to undergo USTs at the CHO, from January to June, this year.
Only 64 patients or 0.08 percent, were found to have abnormal results in their urine and diagnosed with renal disease, Medina said. Of this figure, 61 were diagnosed with urinary tract infections (UTIs), while one each was diagnosed with acute pyelonephritis, nephrolithiasis, and severe UTI R/O pyelonephritis.
REDCOP coordinator Myrle Silva said the highest number of patients, who were made to undergo the UST, was during the month of May with 203 patients.
This was followed by the month of June, 154 patients; January, 148 patients; February, 101 patients; March, 100 patients; and April, 64 patients. (PIA10, Mis. Occ.)
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CMS Proposes Policy, Payment Rate Changes for ESRD Facilities - Renal Business Today |
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WASHINGTON—The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on Monday, July 2, that would update Medicare policies and payment rates for End-Stage Renal Disease (ESRD) facilities paid under the ESRD Prospective Payment System (PPS) for calendar year (CY) 2013.
The proposed rule would also strengthen incentives for improved quality of care and better outcomes for patients through improvements to the ESRD Quality Incentive Program (QIP). Performance scores on the QIP measures during a proposed CY 2013 performance period would affect payments to dialysis facilities in CY 2015.
In addition to other updates, payment rates for outpatient maintenance dialysis treatments are anticipated to increase by 2.5 percent in CY 2013. This reflects the ESRD bundled market basket increase of 3.2 percent reduced by a productivity adjustment of 0.7 percent, as required by statute. CMS estimates that Medicare payments to the 5,633 ESRD facilities in CY 2013 will total $8.7 billion. When all policy changes are considered together, payments to ESRD facilities are expected to increase by 3.1 percent in 2013.
“As we enter the third year of our four year transition to the new fully bundled payment system for certain dialysis facilities, 90 percent of facilities are voluntarily receiving payments under the new system,” said Jonathan Blum, CMS deputy administrator and director of the agency’s Center for Medicare. “We believe that the policies and rate changes proposed today will continue to help ensure that beneficiaries diagnosed with ESRD continue to get the care they need.”
The proposed rule would continue to focus on clinical measures and expand the scope of the reporting measures included in the ESRD QIP to encompass a broader range of patient populations who receive dialysis care and to address concerns about the quality of life experienced by patients on dialysis. Specifically, CMS is proposing that ESRD facilities collect data for four reporting measures to capture information about how well each facility:
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Diaverum Celebrates Five Years as an Independent Company - Business Wire (press release) |
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MUNICH & LUND, Sweden--(BUSINESS WIRE)--Annual growth of more than 10 per cent – focus on improving quality of life for renal patients
“Also the name Diaverum was chosen deliberately: ‘dia’ represents our core business dialysis, while ‘verum’ is Latin for truth. Hence, the name of our company symbolises the honesty, transparency and reliability that Diaverum is known for today.”
Today, Diaverum is celebrating its 5th anniversary as an independent renal care provider. After the divestiture of the Gambro Healthcare Division in 2007 and the founding of Diaverum, the ‘new’ renal care provider has entered several new markets including Germany, Chile, Romania and Saudi Arabia. During this period the number of patients has increased by more than 50 per cent. Diaverum currently operates 252 clinics in 17 countries in Europe, Latin America, Australia and the Middle East.
On the occasion of the anniversary, Dag Andersson, CEO and President of Diaverum, said: “I am very proud of what we have achieved over the last five years. We have been able to leverage the dialysis experience and knowledge from 15 years as part of Gambro, add efficiencies regarding operating dialysis clinics and create a company culture that truly puts the patient in the centre – while at the same time reporting impressive growth figures”. Since June 2007, Diaverum opened more than 80 new clinics. Currently Diaverum cares for more than 20,000 patients worldwide conducting three million dialysis treatments per year.
Young player with a long history
The renal care history of Diaverum started with the founding of the Gambro Healthcare Division in 1991 and the first dialysis clinic opened in Lund, Sweden. Shortly after the divestiture of this division on 2 July 2007, the name Diaverum was adopted and launched globally. The key shareholder is Bridgepoint, a private healthcare investor.
Revitalising renal patients
“When launching Diaverum as independent provider we wanted to form a very unique appearance, reflecting our brand promise to ‘revitalise our patients, both physically and emotionally’. We chose a water colour style designed by a Swedish artist with light, vivid and revitalising expressions, which has proven to stand out in the rather ‘technical’ healthcare market”, explained Christina Sterner, Chief Communication Officer at Diaverum. “Also the name Diaverum was chosen deliberately: ‘dia’ represents our core business dialysis, while ‘verum’ is Latin for truth. Hence, the name of our company symbolises the honesty, transparency and reliability that Diaverum is known for today.”
Committed to quality
The main focus for Diaverum is to provide the highest level of quality care and run the clinics in a very safe and efficient way. Thus, significant efforts are devoted to integrating each new clinic through a 100-day and 1-year integration plan. Diaverum is fostering a culture of quality where all efforts are focussed on ultimately benefitting renal patients. Key elements are the awarded medical and scientific research organisation, the accredited training programmes, clinic audits and employee engagement activities.
Expanding the service offering
The prevalence of two of the most important risk factors for chronic kidney diseases, diabetes and hypertension is increasing at a fast pace. By 2025, it is estimated that 380 million people will suffer from diabetes and 1.6 billion people will have high blood pressure. The number of patients with end stage renal disease (ESRD) is estimated to increase to 4 million by 2025, almost doubling compared to 2010. For ESRD-patients, the only alternative treatments are lifelong dialysis or kidney transplantation. These figures will present significant challenges to health systems.
“We are actively taking measures to seek better ways for early diagnosis and treatment, also from a socioeconomic perspective. We are expanding the services offered, including more preventive and early stage renal care. In some countries, we are already operating nephrology wards and our aim is to actively engage with the wider public and to advise them on how to prevent kidney diseases from the very start”, said Dag Andersson, providing an insight into the near future. “Going forward, we will continue to explore further geographic markets, focus on organic growth and expand our offering. We want to improve the quality of life for an increasing number of renal patients – worldwide.”
To celebrate the 5th anniversary, Diaverum is - amongst other things - having a lottery both on the internal and external website. Visitors on corp.diaverum.com (http://www.corp.diaverum.com/) can win one of five ipods in the typical Diaverum orange.
About Diaverum
At Diaverum, our mission is to improve the quality of life for renal patients by revitalising them both physically and emotionally. Being one of the world’s leading renal care providers, Diaverum offers a holistic approach, from preventive and early stage renal care to all renal replacement therapies. As a product independent provider — the largest in Europe — we are able to focus solely on caring for the individual needs of our patients. Our experience in renal care dates back 20 years, when the first dialysis clinic was established, previously under our former name Gambro Healthcare. Today, 6,900 employees care for more than 20,000 patients in 17 countries in Europe, Latin America, Middle East and Australia. The corporate office of Diaverum is located in Munich, Germany, the head office is in Lund, Sweden. For more information visit www.diaverum.com.
This information was brought to you by Cision http://www.cisionwire.com
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