|By PR Newswire||
|March 20, 2014 06:05 AM EDT||
BETHLEHEM, Pa., March 20, 2014 /PRNewswire/ -- Saladax Biomedical, Inc. announced today that Saladax Biomedical Laboratories is offering a simple blood test for the personalization and optimization of 5-fluorouracil (5-FU) dosing to help oncologists improve treatment outcomes and minimize the drug's toxic side effects. The test is called My5-FU™. 5-FU is a chemotherapy drug commonly used in the treatment of many different cancer types, including colorectal, head & neck and breast cancers.
Presently, chemotherapy dosing is based on the body surface area (BSA) formula, which was developed in 1916 and is used to calculate the surface area of a human body based on an individual's height and weight. The use of BSA for chemotherapy dosing is and has been the standard practice since the introduction of the first chemotherapy drugs in the 1950's, but only due to the lack of a better means for determining the appropriate dose in an individual 1. Since the BSA formula was developed in 1916, we have learned that not all human bodies metabolize medications the same way, in the same time frame, or with the same outcome. No two individuals of the same height and weight will absorb and clear drugs at exactly the same rate. There are many factors besides just height and weight that impact drug absorption and clearance, including age, gender, metabolism, disease state, organ function, drug-drug interactions, and genotype. BSA provided a historical safety net for universal dosing practices, but better precision is what is really needed to obtain optimal outcomes for patients undergoing chemotherapy. Which side of the dosing equation would you want to be on during chemo treatment?
Recent clinical studies have highlighted the serious flaws of the BSA dosing method 2-6. Over 80% of colorectal cancer patients were found to have received therapeutically suboptimal dosing of 5-FU; 68% of these patients were under-dosed, jeopardizing their treatment outcomes, and 13% were overdosed, putting them at high risk of serious toxic side effects from their treatment. To learn more about BSA dosing, and the issues around it, please read visit www.bettercancercare.com.
My5-FU is about to change those statistics.
My5-FU is one of a line of MyCare™ blood tests offered by Saladax Biomedical Laboratories. The test requires a simple venous blood draw to be performed a minimum of two hours prior to the end of a 5-FU infusion cycle. The My5-FU test results provide the oncologist information about the concentration of the drug in the patient's blood as well as their overall systemic exposure to the drug. Based on the exposure levels, the doctor can adjust the next dose to achieve the optimal exposure level for best treatment results with minimized toxicities. This method of personalized dosing is referred to as pharmacokinetic (PK) guided dosing.
It is time for a change to the way your chemotherapy drugs are dosed. The MyCare line of blood tests is now available to truly personalize and calibrate your chemotherapy dosing.
About Saladax Biomedical, Inc.:
Saladax Biomedical is a leader in the development and deployment of high quality diagnostic services and products, delivering actionable data to help physicians to select and optimize the use of current and new pharmaceutical products, with the goals of improving health and positively impacting the economics of care. Saladax also serves as a valuable collaborator for pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.
Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. Since 1988, laboratories must be inspected and pass stringent requirements to be certified and registered as a Clinical Laboratory Improvement Act (CLIA) laboratory. Saladax Biomedical Laboratories is certified and registered under the CLIA regulations by the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans.
- Felici A, Verweij J, Sparreboom A. Dosing strategies for anticancer drugs: the good, the bad and body-surface area. Eur J Cancer. 2002;38:1677–1684.
- Adapted from Saam J, Critchfield GC, Hamilton SA, et al. Body surface area–based dosing of 5-fluorouracil results in extensive interindividual variability in 5-fluorouracil exposure in colorectal cancer patients on FOLFOX regimens. Clin Colorectal Cancer.2011;10(3):203-206.
- Gamelin EC, Delva R, Jacob J, et al. Individual fluorouracil dose adjustment based on pharmacokinetic follow up compared with conventional dosage: Results of a multicenter randomized trial of patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(13):2099-2105.
- Saif MW, et.al. Pharmacokinetically (PK) guided dose adjustment of 5-fluorouracil (5-FU): a rational approach to improving therapeutic outcomes. J Nat'l Cancer Inst. 2009;101(22):1543-1552.
- Capitain O, et al. Individual Fluorouracil (5-FU) Dose Adjustment in FOLFOX Based on Pharmacokinetic (PK) Follow-Up Compared With Conventional Body-Area-Surface Dosing: A Phase II, Proof-of-Concept Study. Clin Colorectal Cancer. 2012;11(4): 263-267.
- Kline CLB, et.al. Personalized dosing via pharmacokinetic (PK) monitoring of 5-Fluorouracil (5-FU) might reduce toxicity in early or late stage colorectal cancer patients treated with infusional 5-fluorouacil-based chemotherapy regimens. Clin Colorectal Cancer. In Press, 2014.
Sean-Patrick M. Hillman, CORBIN-HILLMAN COMMUNICATIONS
SOURCE Saladax Biomedical, Inc.
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
Aug. 30, 2016 06:15 PM EDT Reads: 324
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 30, 2016 05:45 PM EDT Reads: 3,585
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 30, 2016 05:00 PM EDT Reads: 891
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 30, 2016 04:15 PM EDT Reads: 959
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 30, 2016 03:30 PM EDT Reads: 3,775
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 30, 2016 03:00 PM EDT Reads: 852
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 30, 2016 02:30 PM EDT Reads: 953
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 30, 2016 02:30 PM EDT Reads: 1,036
SYS-CON Events announced today that Adobe has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of co...
Aug. 30, 2016 02:00 PM EDT Reads: 3,776
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Aug. 30, 2016 01:45 PM EDT Reads: 654
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Aug. 30, 2016 01:30 PM EDT Reads: 869
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Aug. 30, 2016 01:20 PM EDT Reads: 267
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Aug. 30, 2016 01:15 PM EDT Reads: 2,067
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 30, 2016 01:00 PM EDT Reads: 3,235
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Aug. 30, 2016 11:45 AM EDT Reads: 804