Markets

FDA Okays Bio-Rad D-100 for HbA1c (Diabetes) Testing

Medical products manufacturer Bio-Rad Laboratories, Inc.BIO recently announced that the U.S. FDA has approved its latest D-100 System for HbA1c testing - a common blood test used to diagnose the presence of type 1 and type 2 diabetes in a patient's blood level. This regulatory clearance reflects a significant milestone for Bio-Rad, consistent with its tradition of aiding in the advancement of diabetes management.

Bio-Rad's D-100 System is a fully automated device, which according to management, utilizes high-performance liquid chromatography (HPLC) technology and facilitates monitoring of long-term control of blood glucose levels in diabetes patients.

The instrument also allows physicians to duly identify patients who may be at risk of developing the condition soon. We believe this feature of D-100 is particularly helpful as it will enable physicians to alert their patients in advance, so that preventive measures can be adopted well ahead of time.

Bio-Rad's focus on expansion in diabetes space is significant. Rather alarmingly, diabetes is taking the shape of a global epidemic, with lifestyle-related diseases increasingly affecting an expanding global population. Evidently, according to the estimates of the International Diabetes Federation estimates, more than 415 million adults worldwide are diabetics. The number is expected to increase to 642 million by 2040.

Although diabetes is a curable medical condition, it has been found to be the underlying cause behind complex diseases like heart attack, stroke and many other cardiovascular ailments. According to the American Diabetes Association, diabetes was the seventh leading cause of death in the U.S. in 2010 based on the 69,071 death certificates in which diabetes had been listed as the underlying cause of death.

Hence the need for early detection and necessary treatment of diabetes, that can considerably lower the risk of patients developing long-term complications associated with the condition.

Bio-Rad's D-100 System delivers rapid high-quality HbA1c testing results through a simplified workflow, without sacrificing the ability to detect hemoglobin variants that can interfere with the interpretation of test results.

Interestingly, earlier this year, Bio-Rad commercially launched its D-100 system in Europe, Canada, and several countries in the Asia-Pacific, post receipt of the required CE Mark.

With the global market for diabetes care devices projected to reach $26.96 billion by 2019 at a CAGR of 5.93%, we expect the FDA approval for the D-100 system to enable Bio-Rad to capture a larger share of this market potential, going forward.

Currently, Bio-Rad carries a Zacks Rank #3 (Hold). Some better-ranked medical products stocks are Capricor Therapeutics, Inc. CAPR , ICU Medical, Inc. ICUI and INSYS Therapeutics, Inc. INSY . All the three stocks sport a Zacks Rank #1 (Strong Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

BIO-RAD LABS -A (BIO): Free Stock Analysis Report

ICU MEDICAL INC (ICUI): Free Stock Analysis Report

CAPRICOR THERAP (CAPR): Free Stock Analysis Report

INSYS THERAP (INSY): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story

ICUI BIO CAPR

Other Topics

Stocks

Latest Markets Videos

    Zacks

    Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at www.zacks.com.

    Learn More