Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SpectRx cervical cancer detection

This article was originally published in The Gray Sheet

Executive Summary

Grant of $690,000 from the National Cancer Institute, announced Sept. 13, will go toward completing a pivotal trial for SpectRx' noninvasive LightTouch cervical cancer detection technology. More than 1,100 women have been enrolled in the five-site trial, expected to complete enrollment in 2007. The firm will seek expedited PMA approval of LightTouch as a triage step for women with positive Pap or HPV tests to confirm whether colposcopy and biopsy are warranted. SpectRx has received a total of $3.2 mil. in NCI funding for the product...

You may also be interested in...



SpectRx seeks buyer for insulin pump infusion set unit

Firm's SimpleChoice insulin pump infusion set business is up for sale as part of a broader SpectRx reorganization aimed at refocusing the company on its noninvasive LightTouch cervical cancer detection technology, including funding ongoing pivotal trials of the device, the firm says March 15. SpectRx also is seeking a partner for its development-stage continuous glucose monitoring technology. LightTouch, which uses light to scan the cervix for disease, is intended as a triage step for women with positive Pap smear or human papillomavirus (HPV) tests to confirm whether colposcopy and biopsy are warranted (1"The Gray Sheet" Sept. 18, 2006, In Brief)...

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

UsernamePublicRestriction

Register

LL010986

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel