Biomed's TF-Transit Tubes Approved by Washington State ADL

The Washington State Animal Disease Diagnostic Laboratory has recently anounced their approval and preference for the TF-Transit tube for submitting bovine preputial or vaginal samples for Tritrichomonas foetus PCR testing.

The TF Transit tube is a premium sample collection & transport system specifically designed for bovine ‘Trich’ PCR testing (i.e., trichomoniasis, T. foetus infection). The TF Transit is a field-oriented sample collection device that retains the Gold Standard InPouch™ TF liquid medium, but in a test tube for ease of collection, transport and DNA extraction-- for PCR-only TF testing. The TF-Transit tube is not a diagnostic test.

Biomed’s InTray™ GC Diagnostic Device Helps Health Providers Comply With New Federal Guidelines to Slow Rise of Drug Resistant Gonorrhea

BIOMED’S INTRAY™ GC DIAGNOSTIC DEVICE HELPS HEALTH PROVIDERS COMPLY WITH NEW FEDERAL GUIDELINES TO SLOW RISE OF DRUG RESISTANT GONORRHEA

—Guidelines Call for Stepped-Up Culture-Based Testing to Track Resistance Trends and Ensure Infected Patients are Cured—

—InTray™ GC Combines Sample Collection, Transport & Culture in Read-out Ready Platform, Reducing Handling & Contamination Risk While Increasing Throughput & Productivity—

White City, OR – September 6, 2012 – BioMed Diagnostics, Inc., an innovative manufacturer of microbiology devices that facilitate and enhance infectious disease diagnosis, today reported that the unique design of its InTray™ GC device can help healthcare providers implement new federal guidelines for the treatment of gonorrhea, one of the most common sexually transmitted diseases (STDs.)

The changes announced last month by the Centers for Disease Control and Prevention (CDC) were prompted by evidence that the bacterium that causes gonorrhea is developing resistance to currently-used oral antibiotics.  The new guidelines recommend therapy with a more powerful injectible antibiotic and a second antibiotic, along with culture-based retesting to monitor antimicrobial resistance and ensure that the gonorrhea has been cured.  Patients whose infections are not fully eradicated are at risk of serious complications and they can continue to spead the disease to others.  They may also contribute to development of drug resistance.  

BioMed’s InTray GC uniquely combines sample collection, transport and culture in a single read-out ready platform, enabling simultaneous detection and observation of the bacterium responsible for gonorrhea.  InTray GC reduces handling, increases productivity, improves throughput and reduces the risk of sample exposure and contamination.

The InTray GC system is equipped with an integrated carbon dioxide tablet contained in a sealed inner chamber to prevent degradation during storage.  Once the chamber is punctured and the InTray device sealed, the tablet generates the anaerobic atmosphere needed to detect gonorrhea, eliminating the need for costly carbon dioxide incubators.

“The CDC’s new guidelines reflect the urgency of ensuring that we track resistance trends so that we continue to have effective treatments for gonorrhea, and infected patients are actually cured,” said Jim Self, Chief Executive Officer of BioMed Diagnostics.  “Our one-step Intray GC device has demonstrated its utility in everyday clinical use, making it easier and more economical to detect whether a patient is infected and whether the bacterial strain shows resistance.  We look forward to working with healthcare providers to demonstrate how InTray GC can help them implement the new diagnostic guidelines efficiently and cost effectively.”

Gonorrhea is among the most common STDs, with the CDC estimating that more than 700,000 people in the US acquire new infections each year.  If left untreated, gonorrhea can lead to long-term health consequences, including chronic pelvic pain, ectopic pregnancy and infertility.  It can also increase the risk of contracting and transmitting HIV.

BioMed devices are listed with the US Food and Drug Administration for in vitro diagnostic use in human clinical laboratories.  For more information on InTray GC, visit www.biomeddiagnostics.com/ivd-intray-gc/

 For information on BioMed Diagnostics’ other InTray and InPouch™ infectious disease devices, visit www.biomeddiagnostics.com/clinical.

About BioMed Diagnostics

BioMed Diagnostics, Inc. is a manufacturer of in vitro clinical diagnostic, veterinary, environmental and research-only microbiology testing devices that save time and money, improve workflow and throughput, and reduce sample exposure and contamination.  By combining sample collection, transport and culture in a single read-out ready platform, BioMed’s InPouch™ and InTray™ devices help medical professionals, veterinarians, researchers and environmental and industry scientists accurately detect and enumerate a variety of bacterial and fungal pathogens. The devices’ unique sealed design reduces the risk of pathogen exposure, and they have a long shelf life.  InTray products featuring Colorex™ technology enable easy-to-interpret visual results from a simple color change.  To learn more about BioMed Diagnostics products and services, visit: www.biomeddiagnostics.com.

National Public Radio- All Things Considered: Gonorrhea Evades Antibiotics, Leaving Only One Drug To Treat Disease

Listen to story here:

http://www.npr.org/blogs/health/2012/08/10/158464908/gonorrhea-evades-antibiotics-leaving-only-onedrug-to-treat-disease

Transcript:

Host: Audie Cornish

Reporter: Rob Stein

Interviewed:

Dr. Jonathan Zenilman, Johns Hopkins

Dr. Gail Bolan, Centers for Disease Control and Prevention

There's some disturbing news today about a disease we don't hear about much anymore - gonorrhea. Federalhealth officials say the sexually transmitted infection is getting dangerously close to being drug-resistant and therefore, untreatable. So, as NPR's Rob Stein reports, they unveiled a plan to try to buy more time.

ROB STEIN: Gonorrhea has been plaguing humanity for centuries but ever since penicillin came along, a

dose of antibiotics would usually take care of it. Jonathan Zenilman studies infectious diseases at Johns

Hopkins.

DR. JONATHAN ZENILMAN: Gonorrhea used to be susceptible to penicillin, ampicillin, tetracycline and

doxycycline - very commonly used drugs.

STEIN: But one by one, each of those antibiotics - and almost every new one that has come along since -

eventually stopped working. Zenilman says one reason is that the bacterium that causes gonorrhea can

mutate quickly, to defend itself.

ZENILMAN: If this was a person, this person would be incredibly creative. The bug has an incredible

ability to adapt, and just develop new mechanisms of resisting the impact of these drugs.

STEIN: Another reason is that antibiotics are used way too much when they're not really needed, giving

gonorrhea - and other nasty germs - too many chances to learn how to survive.

ZENILMAN: A lot of this is occurring not because of treatment for gonorrhea, but overuse for other

infections such as urinary tract infections, upper respiratory tract infections and so forth.

STEIN: It got to the point, recently, where doctors only had two antibiotics left that could still cure

gonorrhea. And today, federal officials announced that one of their worst fears had come true. One of those last two had started losing its power, too.

DR. GAIL BOLAN: We are sounding the alarm.

STEIN: That's Gail Bolan, at the Centers for Disease Control and Prevention.

BOLAN: We're basically down to one drug, you know, as the most effective treatment for gonorrhea.

STEIN: And, Bolan says, it gets worse. The one, last drug is in the same family of antibiotics. That means

it's only a matter of time before it goes, too.

BOLAN: The big worry is that we, potentially, could have untreatable gonorrhea in the United States.

STEIN: That's already happening in other countries. Totally untreatable gonorrhea is popping up in Asia and Europe. So the CDC decided to take a big step. Today, the federal agency declared that doctors should immediately stop using the latest antibiotic that's failing.

BOLAN: We feel we need to a take a critical step, to preserve the last remaining drug we know is effective to treat gonorrhea.

STEIN: It's critical because about 700,000 Americans get gonorrhea every year. And gonorrhea can cause serious complications if untreated - unrelenting pain, infertility and even life-threatening, ectopic

pregnancies. William Smith heads an advocacy group that fights sexually transmitted diseases.

WILLIAM SMITH: I think it should be a real clarion call to every American; that we've got a looming

public health crisis on our hands and potentially, hundreds of thousands of cases of untreatable gonorrhea in this country, every year.

STEIN: Officials know implementing the new federal guidelines won't be easy. For one thing, the remaining drug is an injection, not a pill. And they want doctors to give it along with at least one other antibiotic, and test patients, to make sure they're cured. But they know all of this will only help for a while. They can't stop the clock from ticking for the one drug left. Here's Gail Bolan, from the CDC, again.

BOLAN: We think it's only a matter of time, based on the history of this organism, until resistance does

develop.

STEIN: So scientists are searching for new combinations of antibiotics that might work. And officials are

pushing for new weapons that might stay one step ahead of gonorrhea, and the growing list of antibioticresistant infections.

Copyright © 2012 National Public Radio. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to National Public Radio. This transcript is provided for personal, noncommercial use only, pursuant to our Terms of Use. Any other use requires NPR's prior

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Gonorrhea has become immune to all but one type of antibiotic. Additional testing recommended

CDC Expert Commentary

New Treatment Guidelines for Gonorrhea: Antibiotic Change

Listen and watch video here:

http://www.medscape.com/viewarticle/768883

Transcript:

Dr. Bob Kirkcaldy, Medical Officer in the Division of STD Prevention at the Centers for Disease Control

and Prevention (CDC) and lead author on the recently updated gonorrhea treatment guidelines; that were published in Morbidity and Mortality Weekly Report (MMWR).

Gonorrhea is a very common infectious disease. In 2010, more than 300,000 cases of gonorrhea were

reported to CDC. However, CDC estimates that more than 700,000 people in the United States acquire new gonorrhea infections each year.

This sexually transmitted disease (STD) is often asymptomatic, but if left untreated, it can lead to long-term health consequences, including chronic pelvic pain, ectopic pregnancy, and infertility. Gonorrhea can also increase the risk of contracting and transmitting HIV.

Cephalosporins are currently recommended to treat gonorrhea in the United States. For the past few years, providers have used combination therapy with either cefixime, an oral cephalosporin, or ceftriaxone, an injectable cephalosporin, plus a second antibiotic, to treat this common STD.

Recent laboratory data suggest that the effectiveness of cefixime for treating gonorrhea may be declining. For this reason, CDC has updated its gonorrhea treatment guidelines and no longer recommends the routine use of cefixime. Instead, CDC now recommends using ceftriaxone along with a second antibiotic to treat gonorrhea.

I would like to take this opportunity to give you a brief summary of the updated guidelines for treating

gonorrhea. However, the complete guidelines can be viewed at www.cdc.gov/std/treatment.

For patients with uncomplicated genital, rectal, and pharyngeal gonorrhea, CDC now recommends

combination therapy with ceftriaxone 250 mg as a single intramuscular dose, plus either azithromycin 1 g

orally in a single dose or doxycycline 100 mg orally twice daily for 7 days.

There are times, however, when it may be necessary to use an alternative antibiotic regimen that does not include ceftriaxone. In instances where ceftriaxone is not available, CDC recommends cefixime 400 mg orally, plus either azithromycin 1 g orally or doxycycline 100 mg orally twice daily for 7 days. For patients with a severe allergy to cephalosporins, CDC recommends a single 2-g dose of azithromycin orally.

In both of these circumstances, CDC recommends a test of cure for these patients 1 week after treatment, and this is an important change in CDC's treatment guidelines. In addition to these treatment changes, we encourage physicians to take 2 additional steps to ensure successful treatment outcomes for their patients.

First, monitor your patient for treatment failure. Patients who have persistent symptoms after treatment

should be retested by culture. If these cultures are positive for the gonococcus, isolates should be submitted for resistance testing. A test of cure should be conducted 1 week after retreatment. Providers should also ensure that the patient's sex partners from the preceding 60 days are promptly evaluated and treated.

Second, report suspected treatment failures. Any suspected treatment failure should be reported to CDC

through local or state public health officials within 24 hours.

It is important to know that a single 250-mg injection of ceftriaxone is effective in treating gonorrhea at all anatomic sites. There are no clinical data to support the use of higher doses of ceftriaxone. Also, the use of azithromycin as the second antibiotic used in combination therapy may be preferable to the use of

doxycycline, for 2 reasons. First, azithromycin is taken as a single pill, which is easier and more convenient for a patient. And secondly, there was a substantially higher prevalence of gonococcal resistance to tetracycline than to azithromycin among the isolates studied for this MMWR.

The changes in the gonorrhea treatment guidelines were prompted by laboratory data from CDC's

Gonococcal Isolate Surveillance Project (GISP). These data demonstrated recent significant increases in the percentage of Neisseria gonorrhoeae isolates with elevated cefixime minimum inhibitory concentrations (MICs). The percentage of isolates with elevated cefixime MICs increased from 0.1% in 2006 to 1.7% in 2011, a 17-fold increase. CDC anticipates that rising cefixime MICs will soon result in declining effectiveness of cefixime for the treatment of urogenital gonorrhea.

Although there haven't been any documented treatment failures in the United States, the trends reported in this MMWR, the growing number of international reports of cefixime treatment failures, and the bacteria's history of evolving and becoming resistant to antibiotics used for treatment point to the increasing likelihood that gonococcal cephalosporin resistance and treatment failures are on the horizon in the United States.

For more detailed information about gonorrhea or the updated guidelines, please visit CDC's STD

homepage at www.cdc.gov/std.

BIOMED DIAGNOSTICS’ MICROBIOLOGY DIAGNOSTIC DEVICES NOW AVAILABLE WORLDWIDE THROUGH DISTRIBUTION AGREEMENT WITH VWR INTERNATIONAL, LLC

BioMed Diagnostics, Inc  announced today that its patented InTray™ and InPouch™ product lines will now be available worldwide through a new agreement with VWR International, LLC, a global laboratory supply and distribution company.. Under the terms of the agreement, VWR will distribute BioMed’s products for the diagnosis of infectious disease.

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