Pink Sheet 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



Executive Summary

NMS PHARMACEUTICALS ENTERING OTC DIAGNOSTIC MARKET WITH EZ-DETECT fecal occult blood test following FDS's approval of the product June 24. Approved under a 510(k) application, which signifies the product is "substantially equivalent" to tests already on the market, EZ-Detect will be priced at $7 to $8 for a one-unit package that will contain three separate tests. The Newport Beach, California-based NMS said it is establishing distributorships in the U.S. as well as Europe and that negotiations are under way with "several large companies" to handle marketing of the kit. The test is performed by dropping a chemically treated biodegradable tissue paper into the toilet following a bowel movement. If the test is negative, there is no change in tissue color; the tissue turns blue if test results are positive. NMS claims a 100% accuracy rate for the test. Advantages of the EZ-Detect include ease of use and the test's ability to maintain its reading for four to five hours, the company said. According to NMS estlmates, the physician's office market for fecal occult blood tests is about 540 mil. The OTC market should be double that, the firm predicts. NMS said it expects first year sales for EZ-Detect to be $1 mil. to $1.5 mil. EZ-Detect is the fourth fecal occult blood test to enter the OTC market. C.B. Fleet introduced the first such test, DetecaTest, in August 1983, which was followed about a year later by SmithKline's Hemoccult II, introduced in September 1984. Warner-Lambert's Early Detector joined the field this past January. NMS has also submitted a 510(k) application to FDA for a laboratory and physician's office version of the test, ImmunOccult, NMS primarily manufactures and markets immunodiagnostic test kits for laboratories, hospitals and clinics.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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