SYS-CON MEDIA Authors: Xenia von Wedel, Peter Silva, Glenn Rossman, Ava Smith, Elizabeth White

News Feed Item

A Dose of Reality About Chemotherapy Dosing -- Saladax Has The Antidote - My5-FU™

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.

A Dose of Reality About Chemotherapy Dosing -- Saladax Has The Antidote – My5-FU(TM)

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.

Additional information.is available at www.Saladax.com and www.MyCareTests.com.

References:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

PRESS CONTACT: 

Sean-Patrick M. Hillman, CORBIN-HILLMAN COMMUNICATIONS
[email protected]
(212) 246-6528

Logo - http://photos.prnewswire.com/prnh/20140320/NY87101LOGO

SOURCE Saladax Biomedical, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
High-performing enterprise Software Quality Assurance (SQA) teams validate systems that are ready for use - getting most actively involved as components integrate and form complete systems. These teams catch and report on defects, making sure the customer gets the best software possible. SQA teams have leveraged automation and virtualization to execute more thorough testing in less time - bringing Dev and Ops together, ensuring production readiness. Does the emergence of DevOps mean the end of E...
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series dat...
"Verizon offers public cloud, virtual private cloud as well as private cloud on-premises - many different alternatives. Verizon's deep knowledge in applications and the fact that we are responsible for applications that make call outs to other systems. Those systems and those resources may not be in Verizon Cloud, we understand at the end of the day it's going to be federated," explained Anne Plese, Senior Consultant, Cloud Product Marketing at Verizon Enterprise, in this SYS-CON.tv interview at...
"For the past 4 years we have been working mainly to export. For the last 3 or 4 years the main market was Russia. In the past year we have been working to expand our footprint in Europe and the United States," explained Andris Gailitis, CEO of DEAC, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
The Domain Name Service (DNS) is one of the most important components in networking infrastructure, enabling users and services to access applications by translating URLs (names) into IP addresses (numbers). Because every icon and URL and all embedded content on a website requires a DNS lookup loading complex sites necessitates hundreds of DNS queries. In addition, as more internet-enabled ‘Things' get connected, people will rely on DNS to name and find their fridges, toasters and toilets. Acco...
"Cloud consumption is something we envision at Solgenia. That is trying to let the cloud spread to the user as a consumption, as utility computing. We want to allow the people to just pay for what they use, not a subscription model," explained Ermanno Bonifazi, CEO & Founder of Solgenia, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Enthusiasm for the Internet of Things has reached an all-time high. In 2013 alone, venture capitalists spent more than $1 billion dollars investing in the IoT space. With "smart" appliances and devices, IoT covers wearable smart devices, cloud services to hardware companies. Nest, a Google company, detects temperatures inside homes and automatically adjusts it by tracking its user's habit. These technologies are quickly developing and with it come challenges such as bridging infrastructure gaps,...
SYS-CON Media announced that Centrify, a provider of unified identity management across cloud, mobile and data center environments that delivers single sign-on (SSO) for users and a simplified identity infrastructure for IT, has launched an ad campaign on Cloud Computing Journal. The ads focus on security: how an organization can successfully control privilege for all of the organization’s identities to mitigate identity-related risk without slowing down the business, and how Centrify provides ...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"We help companies that are using a lot of Software as a Service. We help companies manage and gain visibility into what people are using inside the company and decide to secure them or use standards to lock down or to embrace the adoption of SaaS inside the company," explained Scott Kriz, Co-founder and CEO of Bitium, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...