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

Epitope Orasure

This article was originally published in The Gray Sheet

Executive Summary

Measles, mumps, and rubella tests run on oral specimens collected with the device "have comparable sensitivity and specificity to blood samples" based on preliminary study results published by Thomas Thieme, PhD, et al. in July 20 Journal of the American Medical Association, the company reports. Based on the results, Thieme et al. conclude that expanded clinical trials with the OraSure saliva collection system are warranted, and that oral fluid testing for antiviral antibodies "could provide an adjunct to the assessment of immunization coverage by questionnaires and medical records." Epitope has a premarket approval application pending at FDA for use of OraSure to collect HIV-1 test samples. If the PMA is approved, the company says it will seek approval of the system in testing for other diseases in light of the "promising results" of the JAMA study. Thieme is an investigator at Epitope and owns stock options in the company

You may also be interested in...



Unilever Hit With Class Action Over Mercury-Laced Pond’s Cream Originating In Mexico

According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.

HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More

GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.

Daraprim Drug Pricing Suit Against Shkreli And Vyera May Signal Future FTC Actions

In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.

UsernamePublicRestriction

Register

MT002625

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