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

Ortho-Clinical Diagnostics HIV assay approval

This article was originally published in The Gray Sheet

Executive Summary

Johnson & Johnson unit receives supplemental PMA approval Oct. 13 for its Vitros Anti-HIV 1+2 Assay to run on its Vitros 5600 Integrated and Vitros 3600 Immunodiagnostic platforms. The test is the first HIV assay to be approved for an integrated platform in the U.S., according to the company. Vitros 5600 allows labs to run HIV and other routine assays on a single platform, which eliminates the need for batch testing, the firm noted. Vitros 5600 and Vitros 3600 launched late last year, and since then, the company has released 112 assays for use on the systems. Approval of the complete 114-assay Vitros menu is expected by 2010. During J&J's Oct. 13 third-quarter earnings call, the firm said the addition of the new Vitros platforms has doubled the applicable market for Ortho-Clinical Diagnostics products

You may also be interested in...



Industry, Agencies Are Making COVID-19 Partnerships Easy

Organizations like BARDA, CEPI and others are looking to partner with industry to rapidly test, manufacture, package and deploy vaccines and therapeutics, identifying areas they want to work together during BIO’s recent summit.

COVID-19 Economic Fallout May Delay Cell And Gene Therapy Reimbursement Solutions

The economic stress on payers caused by the pandemic will cause a setback in the development of payment approaches for regenerative therapy, Blue Cross Blue Shield executive warns.

US Medicare Agency Alters Payments For Use Of Telehealth Tech, Lab Specimen Collection For COVID-19

An interim final rule posted by the CMS this week widens further a series of telehealth exemptions and lab specimen collection payment provisions it has previously issued to help providers during the COVID-19 pandemic.

Topics

UsernamePublicRestriction

Register

MT028060

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