Timely, accurate immunoassay testing for physician offices

Lexington, MA August 2, 2016: Sekisui Diagnostics has significantly expanded its point of care (POC) diagnostics product line through a recent partnership agreement with Qualigen, Inc.  Sekisui Diagnostics is now the exclusive worldwide distributor of the FastPack IP System, Qualigen’s innovative point-of-care system.

POC testing provides rapid, reliable results for multiple conditions for which time-to-result is critical. Market analysis and consulting firm Enterprise Analysis Corporation estimated the U.S. market for POC diagnostics at $3,620 million in 2015. 1

Based on chemiluminescent technology, the FastPack IP System  empowers clinics, hospital-based caregivers, and physician office
laboratories to provide rapid results for Vitamin D, Testosterone, TSH, FT4, total and free PSA, and hCG.

“Our agreement with Qualigen expands our offering in the rapidly growing field of point-of-care diagnostics,” says Robert Schruender, President and COO of Sekisui Diagnostics. “FastPack IP is highly compatible with our current POC business, and our distributor relationships.”

In addition to immunoassay tests performed on the FastPack IP System, Sekisui Diagnostics provides a range of OSOM® rapid tests for Trichomonas and Bacterial Vaginosis to aid in diagnosis of vaginal infections; as well as tests for pregnancy, ulcer-causing Helicobacter pylori, mononucleosis, influenza, and streptococcus A, which is a market leading product. “Practice efficiency may be enhanced by performing these tests onsite, providing an effective way for physicians to offer their patients the convenience of receiving test results and implementation of therapy in a single visit,” Schruender adds. These point-of-care tests complement the company’s range of products, which also includes clinical chemistry reagents and systems; coagulation systems and reagents; and enzymes and specialty biochemicals for manufacturers.

The FastPack IP System is a patented, fully automated, compact, quantitative immunoassay-based system that generates immunoassay results in 12 minutes or less. The FastPack IP System was designed specifically for the physician office and through convenient reagent packs is extremely easy-to-use in a CLIA moderate complexity setting.  Benefits of the system and best-in-class menu include the ability to provide patients with key blood test results in a single office visit helping physicians and practices enhance both patient care and patient satisfaction.

About Sekisui Diagnostics

Sekisui Diagnostics isa global diagnostics company committed to improving patient’s lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network.  Product lines include clinical chemistry and coagulation systems, reagents, infectious disease testing and rapid test kits, as well as enzymes and specialty bio-chemicals.

About Qualigen:

Qualigen Incorporated is a leader in the development, manufacturing and marketing of innovative medical diagnostic products that provide rapid and accurate information directly to physicians and the patients who trust them.  The FastPack IP System is a state of the art, near-patient blood analyzer that provides quantitative immunoassay results, at the push of a button, for important biomarkers in the areas of cancer, metabolic disorders, hormone regulation and pregnancy management.

1Enterprise Analysis Corporation, IVD Market Research 2016

FastPack® is registered trademark of Qualigen Inc.

OSOM® is a registered trademark of Sekisui Diagnostics, LLC

Company Contact

Debra Harrsch
Brandwidth Solutions LLC