Royalty Report: Diagnostic, Medical, Device – Collection: 3949

License Grant

We invested money into a newly formed 50/50 joint venture with another party, to bring to fruition R&D for innovative Point-of-care diagnostic tests.

License Property

The joint venture products will be focused on proprietary lateral flow and optics technologies (whereby a sample of saliva, urine, or whole blood moves across a solid platform to interact with a reagent to produce colorimetric or other changes that can be measured qualitatively or quantitatively) and Point-of-Care delivery of data through novel and inexpensive readers.

Field of Use

We intend to use lateral flow and optics intellectual property for the joint development of point of care diagnostic products for human, forensic and veterinary use.

License Grant

The Japanese Licensor grants to Licensee the non-exclusive license to develop, manufacture, sell and have sold the Licensee Products incorporating Licensor's Technology in Non-Pacific Rim Territories for the Medical Diagnostics Field.

License Property

Chip means a substrate which contains a grating pursuant to the Grating SPR Technology and is coated with a conductive surface.

Flow Cell means a device which allows liquids to flow through it and consist of a Chip and has an optically clear cover slip which is attached to the Chip by a means that allows for fluid flow there through.

Grating SPR Technology means the use of thin conductive films on a surface or surfaces of a grating or other diffracting substrate to conduct chemical analysis.

PATENT NO.                          TITLE                        JAPANESE PATENT NO.
—————————————————————————————-
  US 4,931,384           Optical Assay Technique (Merlin I)             JP 1903195
  US 5,118,608           Optical Assay Technique (Merlin I)             JP 2502222
  US 4,882,288           Assay Technique and Equipment                  JP 1928364
                         (Merlin II)
  US 4,992,385           Polymer-Coated Optical Structures              JP 2528134
                         and Methods of Making and Using                JP 2592588
                         the Same (Cellulose Nitrate Films)

  US 4,828,387           Film Measuring Device and Method               JP 2511057
                         with Internal Calibration to
                         Minimize the Effect of Sample
                         Movement (Calibration Notches)
  US 5,310,686           Polymer-Coated Optical Structures              JP 2710243
                         (Sensor Using Photoresist)
  CA 1,302,875           (Waveguide Sensor)                             JP 2572829
  US 6,093,536           (Enhanced SPR Assay)                           JP 2073383

Field of Use

This agreement pertains to the medical diagnostics field.  Medical Diagnostics Field means those fields, the applications and products which under current laws and regulations of the United States would require approval of the United States Food and Drug Administration if the application or product incorporating the application were sold for clinical use in the United States.

License Grant

The Assignor hereby assigns, conveys and delivers to the Assignee, and the Assignee hereby acquires from the Assignor, all right, title and interest of the Assignor in and to the following; (i) certain inventions, formulae, manufacturing secrets, processes and know-how with respect to the manufacture of certain bio-medical products and (ii) certain intellectual property and inventions used in connection with said products.

License Property

FDA 510K Cleared tests means that the following tests have been giving approval by the U.S. Food & Drug Administration to market the tests and testing device.

FDA 510K Numbers & Approved Tests

Device Name

                                           510(K) Number

Rubella-Cube

                                                K892051

CMV-Cube

                                                K884842

Rotacube (Rotavirus)

                                K884017

Blue Dot Test for Pregnancy
                                
K882588

First Sign (Pregnancy, HCG)

                                K973208

V-Trend Target IM Test (Infectious Mononucleosis)
K890041

Target Strep A

                                                K880460

Target HCG Enzyme Immunoassay Reagents

K862247

Target ASO Test

                                                K910073

Target HCG Test

                                                K914303

Target HCG One-Step
                                  
K903937

V-Trend Target RF Test
                                
K904105

Target Quantitative HCG
                                  
K890131

V-Trend Target CRP Test
                                        
K890423

Target Reader

                                                K885254

510(K) Approved Platform Products
HCG Human chorionic gonadotropin (Pregnancy Test) Rapid enzyme immunoassay test for qualitative detection of HCG in urine, serum and plasma. HCG is a hormone produced by the developing placenta. Serum and urine levels of HCG climb rapidly, starting as soon as the week following implantation, reaching peak levels near the end of the first trimester. One-step technology offers superior speed and simplicity without sacrificing sensitive and specific results.

Strep A Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.

Rubella Rapid enzyme immunoassay test for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage to the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects. Therefore, all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.

CMV Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections a very significant risk in infants and immunocomprised patients.

Rotavirus Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenterics in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocmial infection.

Mono Qualitative and quantitative detection of heterophile antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient’s serum, usually 1 to3 weeks after the onset of symptoms Common symptoms include fatigue, pharyngitis, fever, lymphadenopatherapy and splenomegaly.

CRP C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if monitored on a daily basis. CRP is also predictive of clinical cardiovascular disease.

Reader The Target System Reader is designed to interpret selected membrane enzyme immunoassays. The instrument is designed for laboratory, emergency room or field use and requires only a few minutes to learn to operate. The reader permits more precise, accurate readings of test results than visual interpretation.

Field of Use

Field of Use is defined as Diagnostic testing for any disease or medical condition that can be transmitted by one human to another within the diagnostic health care industry, mobile and non-mobile. The Field of Use herewith does not include diagnostic or analytical testing within the Veterinary and Livestock, Environmental Testing or any military, law enforcement, bioterrorism or homeland security related industries.
Such testing to be done at the point of care, such point of care may include but are not limited to places such as

·
Hospitals

·
Emergency Medical Vehicle Care

·
Mobile Health Clinics

·
Schools

·
Government Agencies

·
Retail Drug Stores

·
Corporations

·
Hospices

·
Assisted Living and Nursing Homes

·
Home Health Care

·
Physician’s offices

License Grant

Our company, along with our joint venture company and the Italian company entered into a license agreement in which the Italian company granted to our joint venture company an exclusive license to manufacture, have manufactured, use, import, offer to sell and/or sell products covered by certain existing and newly developed intellectual property assigned to the Italian company, pertaining to the application of Tr-DNA technology to the field of infectious diseases. In addition, our joint venture company granted to us an exclusive sublicense to manufacture, use, import and/or sell any products covered by the same Italian company's intellectual property licensed by our joint venture company from the Italian company.

License Property

We are a development stage molecular diagnostic company that focuses on the development of DNA-based tests using transrenal DNA or Tr-DNA.  Tr-DNAs are fragments of DNA derived from dying cells inside the body compartment. The intact DNA is fragmented in these dying cells, appears in the blood stream and these fragments have been shown to cross the kidney barrier and can be detected in urine.

Field of Use

Our patented technology uses safe and simple urine collection and can be applied to a broad range of testing including prenatal genetic testing, tumor detection and monitoring, tissue transplantation, infectious disease, forensic identification, drug development and bio-terrorism.

In March 2004, we organized a joint venture with an Italian company, in the form of a research and development company which will conduct research and development on non-invasive diagnostic tests for infectious disease using Tr-DNA methodology.

License Grant

Licensor and Licensee signed a world-wide License Agreement for Licensor's RapidSense technology, specifically for the purpose of making, using and offering for sale saliva tests for Drugs of Abuse.

License Property

RapidSense(R) is a patented technology – a one-step lateral flow test with unique features such as positive read indication for Drugs of Abuse, improved sensitivity, and the ability to read both large and small molecules. The rapid, disposable and point-of-care diagnostic technology is ideal for collection of either urine or oral fluids.

License Grant

The Assignor hereby assigns, conveys and delivers to the Assignee, and the Assignee hereby acquires from the Assignor, all right, title and interest of the Assignor in and to the following; (i) certain inventions, formulae, manufacturing secrets, processes and know-how with respect to the manufacture of certain bio-medical products and (ii) certain intellectual property and inventions used in connection with said products.
Assignor hereby grants Assignee the right to use and display Assignor's trademarks, service marks, and trademarks and trade names that are applicable to Assignor Product(s) under this private labeling agreement. Assignee may use any of Assignor's Marks as part of its corporate, trade or other business name.

License Property

FDA 510K Cleared tests means that the following tests have been giving approval by the U.S. Food & Drug Administration to market the tests and testing device.

FDA 510K Numbers and Approved Tests
Device Name
510(K) Number

Rubella-Cube
K892051

CMV-Cube
K884842

Rotacube (Rotavirus)
K884017

Blue Dot Test for Pregnancy
K882588

First Sign (Pregnancy, HCG)
K973208

V-Trend Target IM Test (Infectious Mononucleosis)
K890041

Target Strep A
K880460

Target HCG Enzyme Immunoassay Reagents
K862247

Target ASO Test
K910073

Target HCG Test
K914303

Target HCG One-Step
K903937

V-Trend Target RF Test
K904105

Target Quantitative HCG
K890131

V-Trend Target CRP Test
K890423

Target Reader
K885254

510(K) Approved Platform Products
HCG Human chorionic gonadotropin (Pregnancy Test) Rapid enzyme immunoassay test for qualitative detection of HCG in urine, serum and plasma. HCG is a hormone produced by the developing placenta. Serum and urine levels of HCG climb rapidly, starting as soon as the week following implantation, reaching peak levels near the end of the first trimester. One-step technology offers superior speed and simplicity without sacrificing sensitive and specific results.

Strep A Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.

Rubella Rapid enzyme immunoassay test for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage to the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects. Therefore, all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.

CMV Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections pose a very significant risk in infants and immunocomprised patients.

Rotavirus Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenterics in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocmial infection.

Mono Qualitative and quantitative detection of heterophile antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient’s serum, usually 1 to3 weeks after the onset of symptoms Common symptoms include fatigue, pharyngitis, fever, lymphadenopatherapy and splenomegaly.

CRP C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if monitored on a daily basis. CRP is also predictive of clinical cardiovascular disease.

Reader The Target System Reader is designed to interpret selected membrane enzyme immunoassays. The instrument is designed for laboratory, emergency room or field use and requires only a few minutes to learn to operate. The reader permits more precise, accurate readings of test results than visual interpretation.

Field of Use

Field of Use means diagnostic testing for any disease or medical condition that can be transmitted by one human to another within the diagnostic health care industry, mobile and non-mobile, which industry focuses on providing healthcare and diagnostic solutions and services, but not limited to Hospitals, Emergency Medical Vehicle Care, Mobile Health Clinics, Schools, Government Agencies, retail drug stores, corporations, Hospices, Assisted Living and Nursing Homes, Home Health Care, and Physician’s offices. The Field of Use herewith does not include diagnostic or analytical testing within the Veterinary and Livestock, Environmental Testing or any military, law enforcement, bioterrorism or homeland security related industries.

License Grant

The Company licensed certain of its technology to Licensee, a company owned by certain of the Company's shareholders.

License Property

Licensor develops and manufactures proprietary and patented point of care, colorimetric diagnostic tests with diverse applications in the clinical sectors for the women's health market.