Bethlehem, PA, May 14, 2024 (GLOBE NEWSWIRE) -- Saladax Biomedical, Inc. (Saladax) is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale in Canada in a rapid six days. This approval recognizes the vital importance of implementing updated guidelines and using 5-Fluorouracil (5-FU) TDM to ensure patients undergoing cancer treatment with this chemotherapy agent get the proper dose..

宾夕法尼亚州伯利恒，2024年5月14日（环球通讯社）--Saladax Biomedical，Inc.（Saladax）高兴地宣布，加拿大卫生部已批准Saladax的5-氟尿嘧啶（My5-FU）检测方法在加拿大快速销售六天。该批准认识到实施最新指南和使用5-氟尿嘧啶（5-FU）TDM的重要性，以确保接受这种化疗药物治疗的癌症患者获得正确的剂量。。

There is increasing concern with 5-FU treatments worldwide because some patients suffer severe toxicities and even death, which may have been avoided. There is growing frustration in the medical community with oncologists who are reticent to adopt the recommended guidelines for 5-FU TDM.

全世界越来越关注5-FU治疗，因为一些患者遭受严重的毒性甚至死亡，这可能是可以避免的。医学界对肿瘤学家越来越失望，他们不愿采用推荐的5-FU TDM指南。

Today, 5-FU infusions are dosed using an antiquated method called “Body Surface Area (BSA).” This method, developed in 1916, is recognized as inadequate. BSA dosing does not account for individual differences between patients, nor does it measure the blood level of the drug in the patient. Multiple studies have demonstrated that most patients are not getting the right dose.

今天，5-FU输注是使用一种称为“体表面积（BSA）”的古老方法给药的。1916年开发的这种方法被认为是不充分的。BSA剂量不能解释患者之间的个体差异，也不能测量患者体内药物的血液水平。多项研究表明，大多数患者没有获得正确的剂量。

Pharmacology guidelines highly recommend that 5-FU levels be measured and adjusted on a patient-by-patient basis. By adjusting the dose to fit the patient, efficacy is improved, and toxicity is minimized..

药理学指南强烈建议逐个患者测量和调整5-FU水平。通过调整剂量以适合患者，可以提高疗效，并将毒性降至最低。。

The Saladax My5-FU blood test, used in multiple countries worldwide, is now approved in Canada, the European Union, China, the United Kingdom, and Israel. The only major country where it is not approved is the United States. The test is remarkably straightforward to implement. Requiring just one blood sample during a chemotherapy cycle, it can easily be run on analyzers already present in clinical laboratories, making levels practical and accessible to healthcare professionals..

Saladax My5 FU血液测试已在全球多个国家使用，目前已在加拿大，欧盟，中国，英国和以色列获得批准。唯一未获得批准的主要国家是美国。该测试非常容易实现。在化疗周期中只需要一个血液样本，就可以很容易地在临床实验室已经存在的分析仪上运行，使水平实用且可供医疗保健专业人员使用。。

“It's imperative that we move away from the assumption that a patient receives the appropriate 5-FU dose based on a one-size-fits-all approach, which is often not the case. The use of real-time blood levels to guide 5-FU therapy management”, as advocated by Salvatore Salamone, Saladax’s CEO “is a critical step forward.

“我们必须摆脱这样的假设，即患者根据一刀切的方法接受适当的5-FU剂量，而事实往往并非如此。Saladax首席执行官Salvatore Salamone所倡导的使用实时血液水平来指导5-FU治疗管理”是向前迈出的关键一步。

How many more patients will unnecessarily suffer from incorrect dosing before this issue is addressed in the US?”.

在美国解决这个问题之前，还有多少患者不必要地遭受不正确的剂量。

ABOUT SALADAX BIOMEDICAL, INC.

关于SALADAX BIOMEDICAL，INC。

Headquartered in Bethlehem, PA, Saladax Biomedical, Inc. is a privately held company that develops, manufactures, and markets assays that provide rapid therapeutic drug levels for essential and life-saving medicines prescribed by psychiatrists and oncologists. Since 2007, Saladax's proprietary technology has been used in clinical laboratories or point-of-care settings to assist clinicians in monitoring and optimizing patient care.

Saladax Biomedical，Inc.总部位于宾夕法尼亚州伯利恒，是一家私营公司，开发、制造和销售检测方法，为精神科医生和肿瘤学家开具的基本药物和救生药物提供快速的治疗药物水平。自2007年以来，Saladax的专有技术已被用于临床实验室或护理点设置，以帮助临床医生监测和优化患者护理。

Additionally, the company collaborates with leading pharmaceutical companies to develop tests for clinical trials and companion diagnostics. For more information, visit MyCareTests.com.

此外，该公司与领先的制药公司合作开发临床试验和伴随诊断的测试。有关更多信息，请访问MyCareTests.com。