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

OraSure HIV test nears market entry

This article was originally published in The Gray Sheet

Executive Summary

Firm targets "mid-summer" launch for its combined OraQuick HIV-1/2 rapid oral fluid test. Prior to launch, OraSure must obtain licensing rights for the test's HIV-2 marker from Bio-Rad and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the diagnostic's oral fluid component. Further, the firm needs FDA clearance for the test's HIV-2 portion; the HIV-1 part received clearance March 26. OraSure plans to submit HIV-2 data and completed clinical tests for the CLIA waiver by June (1"The Gray Sheet" March 29, 2004, p. 3)...

You may also be interested in...



OraSure

OraQuick Advance rapid HIV-1/2 antibody test launch is planned for November, following a summer CLIA waiver for the oral fluid test. OraSure gained approval for the HIV-2 component of the test in March and the HIV-1 claim in June (1"The Gray Sheet" May 3, 2004, In Brief)...

OraSure Targets HIV-1/2, Hepatitis Tests To Grow Business To $250 Mil.

OraSure is setting its sights on obtaining FDA approval of an OraQuick HIV-2 rapid oral fluid test, as well as licensing rights from Bio-Rad for the antibody patents, following approval of an HIV-1 version March 26

COVID-19: WHO Supports Pooling Of Rights, MPP Includes Drugs and Tests

Intellectual property rights are in the spotlight again, after the World Health Organization and the Medicines Patent Pool announced initiatives to help ensure that all countries will be able to access products being developed for COVID-19.

UsernamePublicRestriction

Register

MT020159

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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