SpectRx makes progress with cervical cancer device:
This article was originally published in Clinica
Executive Summary
SpectRx says it has built and tested its first pre-production noninvasive cervical cancer detection device, which is to be used to complete the firm's ongoing US clinical trial necessary for regulatory approval. The beta device and single-patient-use disposables comprise major components planned for use in commercial production. The Norcross, Georgia company believes that the new-generation system will enable it to reach its price-of-production goals, making the technology affordable to physicians. The device, which uses proprietary technology to identify cancers and precancers painlessly by analysing light reflected from the cervix, is to be commercialised by SpectRx' subsidiary, Guided Therapeutics. SpectRx estimates the annual global market potential for a noninvasive cervical cancer test to be over $1.3bn.
You may also be interested in...
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.