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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 physicians office. FastPack hCG will be available for sale to OBGYN, Internal Medicine and Family Practice medical professionals in January 2008.
- Qualigen announces the introduction of FastCHEK™ TSH, a rapid, CLIA waived, qualitative screening test for primary hypothyroidism. FastCHECH TSH is now available to Internal Medicine, Family Practice and OBGYN medical professionals.
- Qualigen files a patent for “A Method and Apparatus for Implementing Differential Heat Seal Strength in Pouch-Based Diagnostic and Medical Products”.
November 2007
- Product sales for the first half of FY 2008 were $3.0 million.
- Net loss for the first half of FY 2008 was ($1.4 million).
- On September 30, 2007, the Company had $4.5 million in cash and short-term investments.
August 2007
- On August 14, 2007, the Company submitted a 510 (k) application for the FastPack hCG Immunoassy 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.
July 2007
- Product sales for the first quarter of FY 2008 were $1.6 million.
- Net loss for the first quarter of FY 2008 was (680,000).
- On June 30, 2007, the Company had $5.1 million in cash and short-term investments.
May 2007
- Revenues for the fiscal year ended March 31, 2007 were $7.5 million.
- Net loss for the fiscal year ended March 31, 2007 was ($2.3 million).
- On March 31, 2007, the Company had $5.6 million in cash and short-term investments.
- 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.
January 2007
- Revenues for the first three quarters of FY 2007 were $6.0 million, compared to $5.4 million for the first three quarters of FY 2006.
- Net loss for the first three quarters of FY 2007 was $1.3 million, compared to a net loss of $246,000 for the first three quarters of FY 2006.
- On December 31, 2006, the company had $5.9 million in cash and short-term investments, compared to $1.6 million on December 31, 2005.
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
- Revenues for the first half of FY 2007 were $4.2 million, compared to $3.7 million for the first half of the prior year.
- Net loss for the first half of FY 2007 was ($689,000), compared to a net loss of ($52,000) for the first half of the prior year.
- On September 30, 2006, the Company had $6.8 million in cash and short-term investments, compared to $1.8 million on September 30, 2005.
- 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.
August 2006
- Revenues for the first quarter of F2007 were $1.9 million, unchanged compared to the first quarter of the prior year.
- Net loss for the first quarter of FY2007 was ($333,000), compared to a net profit of $42,000 for the first quarter of the prior year.
- On June 30, 2006, the Company had $7.2 million in cash and short-term investments.
- Shishir K. Sinha joins the senior management team as Vice President of Operations. Mr. Sinha joins Qualigen, Inc. with 17 years of experience in the immunoassay and molecular diagnostics industries and will be responsible for the manufacturing, quality and materials activities of the Company.
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.
June 2006
- Revenues for the fiscal year ended March 31, 2006 were $7.5 million; a 50% increase over the prior year.
- Net loss for the fiscal year ended March 31, 2006 was ($740,000), a reduction of 63% compared to a net loss of ($1.98 million) for the prior year.
- On March 31, 2006, the Company had $1.4 million in cash and short-term investments.
April 2006
- Gen-Probe exercises it’s 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
- Revenues for the first three quarters of FY2006 were $5.5 million a 56% increase compared with the first three quarters of FY2005.
- Net loss for the first three quarters of FY2006 was ($246,000) a reduction of 75% compared to the Net Loss of ($982,000) for the first three quarters of FY 2005.
- 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.
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