Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Enzo Biochem Gets State Okay for Candida Test Technology

June 7, 2016 By Enzo Biochem, Inc.

The New York State Department of Health has granted conditional approval for use of Enzo Clinical Labs’ AmpiProbe Candidiasis assay, the company’s second test aimed at the rapidly expanding women’s health market and the third to be approved utilizing one of the company’s proprietary technology platforms.

AmpiProbe Candidiasi is a multiplex assay designed to identify the presence of five of the most common species of candida from a single vaginal swab. Industry estimates put the number of tests performed for the identification of candida at more than 10 million per year in the U.S. alone.

It is also estimated that moe than 70 percent of women will develop a candida infection during their reproductive lifetime. While an independent assay, it will also serve as a component of a comprehensive women’s health panel currently under development, according to the company. Additionally, Enzo scientists will deliver a technical presentation at the College of American Pathologists (CAP) annual meeting in September.

The approval of AmpiProbe Candidiasis follows a similar approval granted to Enzo last November by the New York State Department of Health of AmpiProbe HCV for the quantitative detection of hepatitis C virus and prior to that, Enzo’s FlowScript HPV assay. The FlowScript assay, approved in February 2015, is based on proprietary technology allowing the multiplexed analysis of cellular function in a single assay via the simultaneous examination of each and every cell in a given sample.

It is now being used to assist physicians in better evaluating the progression of abnormal pap smears toward cervical cancer. These assays are now being offered by Enzo Clinical Labs to physicians, and also are currently being marketed nationwide, as will AmpiProbe Candidiasis.

The newly approved assays are the forerunners of a comprehensive line of diagnostic products under development by Enzo to address the needs of clinical laboratories that are often locked into closed-system contracts with molecular diagnostic suppliers that, with ever-declining reimbursements, reduce or even eliminate operating margins, the company said.

Products in the company’s development pipeline include an extensive line of assays for detection of numerous women’s health infectious agents as well as for use in the identification of pathogens for other markets. Enzo also reported that it expects to roll out a line of products designed to aid pathologists in distinguishing the characteristics of various tumors from biopsy specimens using technology developed by its scientists. The molecular-based products are targeted at a market estimated to be in excess of $3 billion worth of laboratory service revenue.

Related Articles Read More >

Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech