the microsampling blog / remote microsampling

In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In the US, the device is not for use with saliva samples intended for clinical DNA testing. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content.

infectious diseases & Covid-19: neutralizing antibodies examined

by Neoteryx | 3 min read

infectious diseases & Covid-19: neutralizing antibodies examined

A viral pandemic was something that scientists had long predicted, but when and how it would strike was not known. Scientists and researchers also did not know that it would …

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how remote microsampling supports virtual clinical trials and cuts costs

by Neoteryx | 5 min read

how remote microsampling supports virtual clinical trials and cuts costs

According to a 2014 study, the cost of developing a new drug is $2.6 billion. This high expense doesn’t include the additional cost of post-approval development to determine dosage strengths …

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The Mitra Device is a single-use, non-sterile device used as a specimen collector and for the storage and transport of blood or other biological fluids. It is designed to be used by laboratory and healthcare professionals, or end-users as a container to collect and transport blood or other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA and/or other regulatory requirements.
The Mitra Microsampling Device is a FDA listed Class 1 exempt device, CE-IVD self-certified in the UK and EU, a Class I IVD in Australia, and registered with Health Canada. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.
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