Edition 12: August 2023

Fertilly Launches Fertility Kits with Microsampling Devices in Europe

Fertilly, a German start-up, has launched Europe’s first At-Home Fertility Test Kits that utilize dried blood microsampling via Mitra? devices with VAMS? technology. The CE-IVD registered Mitra??devices are from Neoteryx, the microsampling product brand of Trajan Scientific and Medical. Fertilly’s kits are medically certified and available to consumers in Europe. The kits aim to assist people who are looking to become parents with an easy and timely way to take control of their reproductive health status in the comfort of their own home. After samples have been collected through a quick finger-stick process, the blood samples can be sent to a lab via standard mail for analysis as dried blood.

Many studies have shown that dried blood Mitra samples are high-quality, which helps the lab to generate accurate data without the need for repetitive sampling and testing. Reliable samples reduce the risk of false-positive or false-negative lab test results, thus reducing unnecessary stress for people on the emotional journey to parenthood.

When a woman purchases her?Fertilly At-Home Fertility Test Kit, she can follow the illustrated instructions on using the Mitra device to self-collect tiny blood samples from a finger-stick. After samples have been collected, she mails them to the lab. This is more convenient than having to go into a clinic for a blood draw or to use a service that cold-ships liquid blood samples to keep them viable until they can be tested.

After samples are delivered to the lab, they will be analyzed using state-of-the art instruments and workflows. Anti-Müllerian hormone (AMH) levels will be measured during analysis, which is used as an indicator of a woman’s ovarian reserves (the number of eggs in her ovaries).

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Trajan Lab in Australia Gets ISO Accreditation for Biomarker Analysis, Medical Testing

The?Trajan Analytical Services?(TAS) Laboratory in Australia has been granted accreditation to ISO 15189 and NPAAC Standards for Medical Testing by the National Association of Testing Authorities (NATA). Trajan is now allowed to develop and offer medical testing and biomarker analytical services and products with this Australian accreditation.?Trajan Scientific and Medical?is gaining momentum in its aim to enable decentralized, personalized data-based healthcare with the new ISO accreditation of its analytical biomarker monitoring laboratory in Australia.

Stephen Tomisich, Group CEO & Managing Director of Trajan Scientific and Medical said, "Our goal is to continue to break down the barriers to enable a personalized, preventive data-based healthcare system of the future, with our own NATA-accredited medical lab, we’re now in a position to develop commercial workflows ultimately leveraging Trajan’s broad capabilities from?microsampling tools?through to?laboratory automation. We plan to collaborate broadly to add value and facilitate adoption on scale.”

Trajan's NATA-accredited TAS Laboratory's purpose is to support personalized and decentralized healthcare pathways. With the addition of the accreditation for the lab, the company offers microsampling devices and kits for remote collection of biological samples. Future plans of Trajan Analytical Services (TAS) and the TAS Lab include developing and validating methods for the entire range of Trajan's microsampling devices, which are IVD registered by the Therapeutic Goods Administration (TGA) in Australia for both research and medical use.

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