January 2009

• Qualigen announces the introduction of its newest generation of FastPack^® analyzer called the FastPack^® IP System. This system utilizes a newly designed test pack that incorporates a unique injection port (IP) which allows the user to inject the patient sample directly into the test pack, thus creating a fully self-contained, sealed pack. The FastPack^® IP System is designed specifically for the physician's office laboratory to produce "Just-in-Time" assay results quickly and easily.
• Qualigen participates in the filing of 7 joint international and US patents with Gen-Probe, Inc. These patent applications cover various aspects of FastPack technology as applied to molecular diagnostics.

December 2008

• The Company receives a registered trademark for "FastCHEK".

November 2008

• Qualigen files a patent application for an "Improved Sample Injection Port for Laminated Devices". This patent application covers technology utilized in the recently introduced FastPack^® IP System.

July 2008

• The Company receives a registered trademark for "QUALIGEN".

June 2008

• Qualigen granted Japanese patent no. 4138250 for "Methods and Apparatus for Conducting Tests". This patent covers various aspects of Qualigen's core technology already patented in the US and Europe.

May 2008

• Qualigen files a patent application for "Methods and Apparatus for Performing Multi-Analyte Detection in a Microdiagnostic Device".

April 2008

• Qualigen announces the introduction of the FastPack^® hCG Immunoassay. This test will enable physicians to detect, confirm and monitor pregnancy with a fully-quantitative result while the patient is still in the physician's office. FastPack^® hCG is now available to Internal Medicine, Family Practice and OB/GYN medical professionals.

December 2007

• Qualigen received FDA clearance for its FastPack^® hCG test, the first quantitative immunoassay for the early detection and monitoring of pregnancy that gives results in minutes while the patient is in the physician's office. FastPack hCG will be available for sale to OBGYN, Internal Medicine and Family Practice medical professionals in April 2008.
• Qualigen files a patent for "A Method and Apparatus for Implementing Differential Heat Seal Strength in Pouch-Based Diagnostic and Medical Products".

August 2007

• On August 14, 2007, the Company submitted a 510 (k) application for the FastPack hCG Immunoassay Kit. When cleared, this product will be used primarily by OBGYN, Internal Medicine and Family Practice medical professionals for the early detection and monitoring of pregnancy.
• Qualigen received FDA clearance and on August 17, 2007 introduced a FastPack PSA Method Verification Kit for use by Qualigen customers to more easily meet the CLIA calibration requirements for the Company's FastPack Immunoassay Test System.

May 2007

• Qualigen was granted a United States patent (No. 7,214,544) covering therapeutic applications of its core technologies.
  

February 2007

• The Annual Stockholder’s Meeting was held at Qualigen’s corporate headquarters on February 13, 2007.
• Paul A. Rosinack, Paulita M. LaPlante and Michael J. Spalding, M.D. were re-elected to the Board of Directors.
• The stockholders ratified the Board appointment of the firm of CEA, LLP as the Company’s independent certified public accountant.
• Qualigen received a Notice of Allowance from the US Patent & Trademark Office for patent claims involving therapeutic applications of its core technologies.
• Qualigen was granted a Japanese patent (No. 3863373) for its Blood Separation Technology already patented in the United States.

October 2006

• Qualigen expands its Sales Team from 5 to 7 and its System/Customer Support Team from 4 to 5 to facilitate entry into the thyroid testing market with FastPack TSH and FastPack Free T4. View Products
• The Company has filed 3 patent applications which will expand the intellectual property underlying the FastPack System.

September 2006

• On September 26, 2006, the Company submitted a PMA application to expand the use of its FastPack PSA test to include patient screening.
• On September 28, 2006, the Company submitted a 510 (k) application for a FastPack PSA Method Verification Kit. When cleared, this product will be used by Qualigen’s customers to more easily meet the CLIA requirements for test system calibration.

July 2006

• Qualigen introduces two new FastPack^® tests for thyroid testing. FastPack TSH and Free T4 are now available to Internal Medicine and Family Practice medical professionals.

April 2006

• Gen-Probe exercises its option to develop a novel platform for rapid molecular testing by purchasing a minority interest in Qualigen. View Press Release (PDF)>
  

February 2006

• The Annual Stockholder's Meeting was held at Qualigen's corporate headquarters on February 13, 2006.
• Paul A. Rosinack, Paulita M. LaPlante and Michael J. Spalding, M.D. were re-elected to the Board of Directors.
• The stockholders ratified the Board appointment of the firm of CEA, LLP as the Company's independent certified public accounts and approved the Company's 2005 Stock Option Plan.
  

January 2006

• On January 4, 2006, FDA awarded Qualigen a clearance to begin to sell Thyroid Stimulating Hormone (TSH). This product will complement the already cleared Free Thyroxine (FT4) giving Qualigen the basic thyroid tests necessary to evaluate thyroid disease as well as monitor replacement therapy.
  

back to top