According to FDA, today’s laboratory-developed tests are frequently manufactured using components and instruments that are not legally marketed for clinical use, and often rely on high-technology instrumentation and software to generate results and clinical interpretations.
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The Myeloma Prognostic Risk Signature will be used as en entry criterion for a Phase II trial of an investigational new drug to treat multiple myeloma patients.
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Shifting interpretations of the CLIA guidelines will allow clinical laboratories to develop alternative quality control policies, replacing equivalent quality control procedures, as of January 1, 2016. Rose Mary Casados, president of COLA Resources Inc, outlines the steps involved in establishing an Individualized Quality Control Plan.
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Featured products include virtual slide database management software from Zeiss, a walk-away clinical chemistry analyzer from the Diatron Group, and a drugs-of-abuse testing platform from Siemens Healthcare Diagnostics.
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MedMira’s multiplex rapid tests for HIV, syphilis, and hepatitis B and C, will be used in mobile clinics in Central Asia.
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