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Saladax Biomedical, Inc.

From EverybodyWiki Bios & Wiki


Saladax Biomedical, Inc.
Private
ISIN🆔
Industry
Founded 📆
Founders 👔
Headquarters 🏙️,
116 Research Dr, Bethlehem, Pennsylvania
Area served 🗺️
Worldwide
Key people
Products 📟 
Members
Number of employees
9-40
🌐 Website
📇 Address
📞 telephone

Saladax Biomedical, Inc. is an in vitro diagnostics company that develops and manufactures blood tests to measure the level of medication in a patient’s blood.[1] Knowing the amount of drug in a patient’s blood allows physicians to individualize dosing.[2] This practice is known as therapeutic drug monitoring (TDM).[3][4]

History[edit]

Saladax focused first on developing tests to measure chemotherapy levels. Chemotherapy drugs are ideal candidates for TDM, because when over dosed, they are highly toxic, and when under dosed, they are less effective.[5][6][7] Saladax’s oncology assays (tests) measure the levels of chemotherapy in a patient’s blood, enabling oncologists to adjust doses of chemotherapy treatment. Saladax has developed tests for: imatinib, 5-fluouracil, paclitaxel and docetaxel.[8][9][10][11][12][13][14]

Tests for antipsychotic medications are in development. Saladax is ISO 13485 certified. Products are CE marked and approved for use in China.[15][16][17] Saladax has collaborated with major cancer research centers, conducting clinical trials to evaluate the value of targeting drug exposure based on blood levels.[18][19][20][21][22][23][24][25] One of these trials was a randomized study of paclitaxel Therapeutic Drug Monitoring (CEPAC-TDM) conducted in collaboration with the Central European Society for Anticancer Research (CESAR).[18] This was the largest study completed in oncology therapeutic drug monitoring, and demonstrated a benefit for patients with non-small cell lung cancer (NSCLC).[19] Results from another large randomized study with the department of Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China, for paclitaxel in NSCLC, also demonstrated that TDM resulted in reduced toxicity with better progression free survival, lending further support to the utility of TDM in oncology.[21] A study of therapeutic drug monitoring of infusional 5-fluoruracil, a widely used agent in colorectal cancer, was conducted with the CESAR group.[18][26] This was a prospective multicenter study that demonstrated the utility of 5-FU TDM in routine clinical practice. 5-FU exposure was significantly improved when dosing was personalized using TDM.[24]

Saladax also develops novel tests in collaboration with major pharmaceutical companies (Bristol-Myers Squibb, Fosun Long March)[27][28][29] Assays for the detection of amyloid beta and tau protein, biomarkers for Alzheimer’s disease, were developed in collaboration with pharmaceutical partners. Siemens Healthineers were granted a non-exclusive license in 2009.[30]

References[edit]

  1. ↑ "Devices and Diagnostics - Life Sciences Greenhouse of Central Pennsylvania". Life Sciences Greenhouse of Central Pennsylvania. Retrieved 2018-04-23.
  2. ↑ Momper JD, Wagner JA (February 2014). "Therapeutic drug monitoring as a component of personalized medicine: applications in pediatric drug development". Clinical Pharmacology and Therapeutics. 95 (2): 138–40. doi:10.1038/clpt.2013.227. PMID 24253660.
  3. ↑ Kang JS, Lee MH (March 2009). "Overview of therapeutic drug monitoring". The Korean Journal of Internal Medicine. 24 (1): 1–10. doi:10.3904/kjim.2009.24.1.1. PMC 2687654. PMID 19270474.
  4. ↑ Hallworth, Mike; Watson, Ian (2017). Holt, David, ed. Therapeutic Drug Monitoring: Clinical Guide (PDF). Abbott Laboratories. Search this book on
  5. ↑ Beumer, JH (March 2013). "Without Therapeutic Drug Monitoring, There Is NoPersonalized Cancer Care" (PDF). Nature Publishing Group. 93 – via Xuebalib.
  6. ↑ "Therapeutic drug monitoring opportunities in cancer therapy". Pharmacology & Therapeutics. 74 (1): 39–54. 1997-01-01. doi:10.1016/S0163-7258(96)00201-X. ISSN 0163-7258.
  7. ↑ Hon YY, Evans WE (February 1998). "Making TDM work to optimize cancer chemotherapy: a multidisciplinary team approach". Clinical Chemistry. 44 (2): 388–400. PMID 9474050.
  8. ↑ Beumer JH, Kozo D, Harney RL, Baldasano CN, Jarrah J, Christner SM, Parise R, Baburina I, Courtney JB, Salamone SJ (August 2015). "An Automated Homogeneous Immunoassay for Quantitating Imatinib Concentrations in Plasma". Therapeutic Drug Monitoring. 37 (4): 486–92. doi:10.1097/FTD.0000000000000178. PMC 4486633. PMID 25551407.
  9. ↑ Salamone SJ, Benfield CN, Courtney JB, Harney RL, Kozo DR, Li Y, Lundell GD (2011-02-01). "Rapid 5-fluorouracil plasma quantification by immunoassay: Validation with FOLFOX6 clinical samples". Journal of Clinical Oncology. 29 (4_suppl): 563–563. doi:10.1200/jco.2011.29.4_suppl.563. ISSN 0732-183X.
  10. ↑ Beumer JH, Boisdron-Celle M, Clarke W, Courtney JB, Egorin MJ, Gamelin E, Harney RL, Hammett-Stabler C, Lepp S (December 2009). "Multicenter Evaluation of a Novel Nanoparticle Immunoassay for 5-Fluorouracil on the Olympus AU400 Analyzer". Therapeutic Drug Monitoring. 31 (6): 688. doi:10.1097/FTD.0b013e3181b9b8c0. ISSN 0163-4356.
  11. ↑ Cline D, Lundell GD, Harney RL, Zhang H, Raiz H, Li Y, Courtney JB, Bertino JR, Salamone SJ (2011-05-20). "A novel immunoassay to quantify paclitaxel in plasma using monoclonal antibody–coated nanoparticles". Journal of Clinical Oncology. 29 (15_suppl): e11544–e11544. doi:10.1200/jco.2011.29.15_suppl.e11544. ISSN 0732-183X.
  12. ↑ Cline DJ, Zhang H, Lundell GD, Harney RL, Riaz HK, Jarrah J, Li Y, Miyazaki M, Courtney JB, Baburina I, Salamone SJ (December 2013). "Development and evaluation of a nanoparticle-based immunoassay for determining paclitaxel concentrations on routine clinical analyzers". Therapeutic Drug Monitoring. 35 (6): 809–15. doi:10.1097/FTD.0b013e318296be01. PMID 24263640.
  13. ↑ Salamone, S. J.; Zhang, H.; Harney, R. L.; Lundell, G. D.; Cline, D. J.; Raiz, H.; Li, Y.; Courtney, J. B. (2011-05-20). "Quantification of docetaxel plasma concentrations using a novel nanoparticle-based immunoassay". Journal of Clinical Oncology. 29 (15_suppl): e11545–e11545. doi:10.1200/jco.2011.29.15_suppl.e11545. ISSN 0732-183X.
  14. ↑ Cline DJ, Zhang H, Lundell GD, Harney RL, Riaz HK, Jarrah J, Li Y, Miyazaki M, Courtney JB, Baburina I, Salamone SJ (December 2013). "An automated nanoparticle-based homogeneous immunoassay for determining docetaxel concentrations in plasma". Therapeutic Drug Monitoring. 35 (6): 803–8. doi:10.1097/FTD.0b013e31829617ea. PMID 24263639.
  15. ↑ "Saladax Gets CE Marking for Cancer Assay". Retrieved 2018-04-23.
  16. ↑ "Saladax Biomedical, Inc. Extends Availability of its MyCare™ Portfolio in Europe | FiercePharma". www.fiercepharma.com. Retrieved 2018-04-23.
  17. ↑ "Personalized Chemotherapy Tests Cleared for Use in China". Retrieved 2018-04-23.
  18. ↑ 18.0 18.1 18.2 "Central European Society for Anticancer Research (CESAR) Study of Paclitaxel Therapeutic Drug Monitoring - Full Text View - ClinicalTrials.gov". Retrieved 2018-04-23.
  19. ↑ 19.0 19.1 Joerger M, von Pawel J, Kraff S, Fischer JR, Eberhardt W, Gauler TC, Mueller L, Reinmuth N, Reck M, Kimmich M, Mayer F, Kopp HG, Behringer DM, Ko YD, Hilger RA, Roessler M, Kloft C, Henrich A, Moritz B, Miller MC, Salamone SJ, Jaehde U (October 2016). "Open-label, randomized study of individualized, pharmacokinetically (PK)-guided dosing of paclitaxel combined with carboplatin or cisplatin in patients with advanced non-small-cell lung cancer (NSCLC)". Annals of Oncology. 27 (10): 1895–902. doi:10.1093/annonc/mdw290. PMID 27502710.
  20. ↑ Zhang J, Qi H, Zhou C, Ni H, Li Y (2015-05-20). "Paclitaxel (PTX) dose individualization by exposure optimization in Chinese patients with advanced non small-cell lung cancer (NSCLC) receiving first-line paclitaxel-carboplatin (PC) chemotherapy". Journal of Clinical Oncology. 33 (15_suppl): 8052–8052. doi:10.1200/jco.2015.33.15_suppl.8052. ISSN 0732-183X.
  21. ↑ 21.0 21.1 Salamone, S.J. (2017). "Open-label randomized study of individualized pharmacokinetically(PK)-guided dosing versus body surface area (BSA) dosing ofpaclitaxel (PTX) in advanced Non-Small Cell Lung Cancer (NSCLC) NCT02058433" (PDF). Oxford University Press – via European Society for Medical Oncology.
  22. ↑ TECHNOLOGY, DATA. "CESAR and Saladax Biomedical Collaborate on a Study of Optimized 5-FU Dosing in Colorectal Cancer Patients - CESAR - Forschung in der Onkologie - Aktuelles / News / Aktuelle News". www.cesar.or.at. Retrieved 2018-04-23.
  23. ↑ Salamone SJ, Jaehde U, Mueller L, Link K, Holdenrieder S, Bertsch T, Ko Y, Kunzmann V, Suttmann I (2017-02-01). "Prospective, multi-center study of 5-fluorouracil (5-FU) therapeutic drug management (TDM) in metastatic colorectal cancer (mCRC) patients treated in routine clinical practice". Journal of Clinical Oncology. 35 (4_suppl): 650–650. doi:10.1200/JCO.2017.35.4_suppl.650. ISSN 0732-183X.
  24. ↑ 24.0 24.1 Wilhelm M, Mueller L, Miller MC, Link K, Holdenrieder S, Bertsch T, Kunzmann V, Stoetzer OJ, Suttmann I, Braess J, Birkmann J, Roessler M, Moritz B, Kraff S, Salamone SJ, Jaehde U (December 2016). "Prospective, Multicenter Study of 5-Fluorouracil Therapeutic Drug Monitoring in Metastatic Colorectal Cancer Treated in Routine Clinical Practice". Clinical Colorectal Cancer. 15 (4): 381–388. doi:10.1016/j.clcc.2016.04.001. PMID 27256667.
  25. ↑ Juenke JM, Miller KA, McMillin GA, Johnson-Davis KL (June 2011). "An automated method for supporting busulfan therapeutic drug monitoring". Therapeutic Drug Monitoring. 33 (3): 315–20. doi:10.1097/FTD.0b013e318214cd75. PMID 21544019.
  26. ↑ "Chemotherapy for Colorectal Cancer". www.cancer.org. Retrieved 2018-04-23.
  27. ↑ "Bristol-Myers Squibb and Saladax Biomedical Expand Collaboration for Diagnostic Assays for Alzheimer's Disease | FiercePharma". www.fiercepharma.com. Retrieved 2018-04-23.
  28. ↑ "Saladax Biomedical Enters into Master Collaboration Agreement with Bristol-Myers Squibb | FiercePharma". www.fiercepharma.com. Retrieved 2018-04-23.
  29. ↑ Inc., Saladax Biomedical,. "Saladax Biomedical Receives $22.4 Million Strategic Equity Investment From Shanghai Fosun Pharmaceutical". www.prnewswire.com. Retrieved 2018-04-23.
  30. ↑ "Saladax Licenses Alzheimer's Diagnostic Tests to Siemens Healthineers". Retrieved 2018-04-23.


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