Benefits, challenges of LC-MS/MS for antifungal therapeutic drug monitoring | Blood test hailed as step forward for precision cancer drugs | Novel automated blood test shows promise in malaria diagnosis
June 20, 2017
AACC SmartBrief
Top Story
Benefits, challenges of LC-MS/MS for antifungal therapeutic drug monitoring
Labs are increasingly using liquid chromatography tandem-mass spectrometry for antifungal therapeutic drug monitoring because of increased sensitivity, specificity and rapid throughput compared with other methods. This piece discusses seven factors to consider when developing an LC-MS/MS method and notes that "future development should focus on simplifying the technology and making these complex instruments more affordable and robust, easier to use, and more open to automation."
Clinical Laboratory News (6/2017) 
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Science Briefs
Blood test hailed as step forward for precision cancer drugs
A blood test could help identify which advanced prostate cancer patients will respond to a type of targeted treatment called PARP inhibitors, as well as predicting how the drugs will affect their survival and how likely they are to develop resistance. Larger studies are still needed to determine whether doctors can rely on the test.
BBC (6/19),  Medical News Today (6/19) 
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Tech Briefs
Novel automated blood test shows promise in malaria diagnosis
A new automated blood test with a data fingerprint derived from an algorithm containing 30 parameters in the blood developed by Dutch and Austrian researchers yielded a malaria diagnosis rate of 120 blood tests per hour at 97% accuracy. The test earned the researchers the European Inventor Award from the European Patent Office.
Zee News (India)/Press Trust of India (6/18), (Netherlands) (6/16) 
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Policy Briefs
Essential Diagnostics List to be developed by WHO
The World Health Organization is expected to develop an Essential Diagnostics List, using recommendations from an expert committee, to provide evidence-based guidance for creating national lists of essential diagnostic products. The organization will form a Strategic Advisory Group of Experts on In Vitro Diagnostics that will serve as an advisory body for policies and list development.
Regulatory Focus (6/16) 
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Practice Briefs
Thermo Fisher secures clearances, registration for buprenorphine assay
Thermo Fisher Scientific has obtained clearance from the FDA to market its CEDIA Buprenorphine II assay, designed to specifically detect buprenorphine and its three major metabolites. The immunoassay, which does not significantly cross-react with other opioids, has also received CE mark approval from European regulators, as well as registration in various EU countries, Australia, Canada and New Zealand.
FDAnews (6/13) 
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Biocartis' EGFR mutation test wins EU approval
European regulators have given Biocartis CE mark approval for its Idylla EGFR Mutation Test for lung cancer. The PCR-based test, which requires hands-on time of less than two minutes, directly detects 51 EGFR mutations from a slice of FFPE tissue and produces results in 2.5 hours.
360Dx (tiered subscription model)/GenomeWeb Daily News (6/13) 
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EU expands approval for Agilent's Opdivo companion Dx
European regulators have given Agilent Technologies expanded CE mark approval for its Dako PD-L1 IHC 28-8 pharmDx test for use in determining which urothelial cancer patients are most likely to benefit from Bristol-Myers Squibb's cancer drug Opdivo. The test is already approved for use in tumor cell PD-L1 expression for melanoma, non-squamous non-small cell lung cancer and squamous cell carcinoma of the head and neck.
360Dx (tiered subscription model)/GenomeWeb Daily News (6/16) 
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Business/Corporate Briefs
HTG, Qiagen unit enter into statement of work
A statement of work has been signed by HTG Molecular Diagnostics and a Qiagen subsidiary to perform initial-phase development work on a sequencing-based companion diagnostic assay. Net profits from the initial phase will be shared by both companies.
Reuters (6/14) 
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Siemens Healthineers, Fast-track Diagnostics partner on molecular Dx
A strategic alliance has been reached by Siemens Healthineers and Fast-track Diagnostics allowing the addition of Fast-track's CE-marked kits and multi-syndromic panels -- which cover childhood infections, respiratory conditions, central nervous system conditions and gastroenteritis -- to Siemens' Versant kPCR Molecular System menu. The companies did not disclose additional terms.
GenomeWeb Daily News (free registration) (6/13) 
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Engaging Your Team From Good To Great
Webinar: Join AACC and LabLeaders on July 5 to learn the skills needed to boost employee engagement in today's fast-changing environment.
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Mass Spectrometry and Separation Sciences for Laboratory Medicine 7th Annual Conference
Oct. 5, 2017 // 9.5 Credits // Philadelphia, PA
The 7th Annual Mass Spectrometry and Separation Sciences for Laboratory Medicine Conference will engage laboratory scientists, from trainees in clinical chemistry to laboratory directors and pathologists, on current and future clinical applications for mass spectrometry.
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