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

UsernamePublicRestriction
UsernamePublicRestriction

MILES THEOPHYLLINE MONITORING TEST FOR MD OFFICE USE

Executive Summary

MILES THEOPHYLLINE MONITORING TEST FOR MD OFFICE USE will allow physicians to better tailor drug dosage regimens to individual patients, the firm pointed out in a March 27 press release announcing approval of the test. "In the absence of in-office drug monitoring capabilities, most doctors have been prescribing standard medication doses that are safe for everyone," Ames Div. President Richard Falb. PhD, asserted in the release. "Such standard doses often are not enough to optimally control the disease in many patients." The new test "will enable doctors to routinely monitor how much of the Rx actually reached the patient's blood-stream and to optimize dosage levels accordingly." The theophylline monitoring test, which is designed for use exclusively with Miles' Seralyzer bench top analyzer, is the first drug monitoring test aimed at the physician's office market, according to the firm. Additional tests for drugs such as phenobarbital and phenytoin are in the final stages of development. Better theophylline dosing could save "millions of dollars annually" in emergency room and hospital costs, Miles maintained. The firm cited a study published in the Annals of Allergy which estimated that "as many as 50% of patients on standard doses of theophylline may be underdosed and subject to asthma attacks. Another 10% to 20% may be overdosed and at risk of toxicity." Developed by Ames, the test received clearance from FDA's Center for Devices & Radiological Health through the abbreviated 510(k) process. The test was determined by FDA to have "substantial equivalence" to other marketed theophylline monitoring tests. The theophylline test will be launched in April. The monoclonal antibody-based test employes Ames' "dry" reagent technology and will be marketed in strip form. The seralyzer's turnaround time for the test is about four minutes, Miles said. According to the firm, the Seralyzer is the first in-office system to perform both routine blood testing and drug monitoring. Since is introduction two years ago, about 2,000 systems have been installed.

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

UsernamePublicRestriction

Register

OM006051

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

Cancel