Category Archives: Medical Diagnostics

Biomarkers, immunoassays, MRI, ultrasound, etc.

Differentially Expressed in Squamous Cell Carcinoma Gene 1

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Summary:

Researchers at The Ohio State University have provided a novel method for diagnosing and treating squamous cell carcinoma and prostate cancer. This invention is based upon the detection of a specific gene (serine protease gene) encoding a human protein called Differentially Expressed in Squamous Cell Carcinoma Gene-1 or “DESC1″. The invention also provides for DESC1 vectors, host cells, antibodies directed to DESC1 polypeptides, hybridization probes, and primers useful in the method of detecting DESC1 mRNA.

Squamous cell carcinoma is the second most common form of skin cancer. This condition is typically diagnosed by visual examination of the morphological characteristics (shape, form, arrangement, etc.) of tissue samples by a cytologist or pathologist. The potential for human error inherent in these methods has thus made it desirable to develop more reliable and efficient techniques. Investigation into the underlying genetics of the disease has led to the identification of several genes of interest. The DESC1 gene, for instance, is expressed in significant levels in epithelial tissues of the head, neck, oral mucosa, tonsils, prostate, testes, and skin in healthy individuals. However, the gene is repressed in squamous cell carcinoma of the head, neck, prostate, and testes, as compared to normal tissue specimens. It has also been determined that DESC1 is not expressed in colon carcinoma, lung carcinoma, melanoma, or HeLa cells. This gene may prove a useful marker for the detection and treatment of squamous cell carcinoma and other skin cancers.

Potential Applications:

  • Diagnosing squamous cell carcinoma, prostate cancer, and other epithelial cancers in a tissue sample.
  • Therapeutic gene to treat squamous cell carcinoma, prostate cancer, and other epithelial cancers.

Advantages:

  • Differential expression of DESC1 permits a novel and improved method for diagnosing squamous cell and prostate carcinoma without the need for visual examination.
  • Expression of DESC1 can be determined using conventional procedures.
  • Down regulation of DESC1 during the progression of squamous cell carcinoma may provide a basis for therapeutic targets.

NOx Sensor with Improved Selectivity and Parts-Per-Billion Sensitivity

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Summary:

Nitrogen Oxides (NOx) present a host of environmental and health problems, including acid rain, urban smog, acidification of lakes and streams, and damage of forest soils.  The major source of NOx is from the combustion of fossil fuels, and NOx sensors are employed in the development of internal combustion engines in order to optimize combustion and minimize emissions.  Nitric Oxide is also an important biological molecule and its level in human breath is also an indication of many diseased states, including asthma.

Resistance-based electrochemical NOx sensors, while exhibiting good sensitivity, often react to many different gases, and selectivity suffers.  Potentiometric sensors offer a promising approach for NOx measurements in harsh environments, but often suffer from interference with other gases.

Researchers at The Ohio State University have developed a novel potentiometric NOx sensor that overcomes the interference limitations of previous potentiometric sensors.  This sensor is extremely selective to NOx in the presence of other gas species, and sensitivities have been confirmed in the parts-per-billion range!  The sensor is ideal for incredibly precise NOx measurements in environments as diverse as engines and for breath monitoring.

Potential Applications:

  • Medical diagnostics
  • Combustion optimization
  • Environmental NOx monitoring

Advantages:

  • Ridiculously high sensitivity (ppb range!)
  • Excellent selectivity
  • Will withstand extreme environments
  • Cost effective as potentiometric output does not require sophisticated support electronics

Detecting Mutations Associated with Hypertrophic Cardiomyopathy in Cats

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Summary:

Hypertrophic cardiomyopathy (HCM) is one of the most common causes of sudden cardiac death in young adults and is an inherited disease in at least 60 percent of cases. Mutations associated with this disease have been identified in the myosin binding protein C (MYBPC3) gene. Although several other mutations have been identified, the disease process is still poorly understood.

Familial HCM in the cat has been identified and may be used as a model for the human disease. As the first spontaneous animal model of this familial disease, feline familial HCM provides a valuable model for investigators to evaluate the disease process and the effect of therapeutic (drug or genetic) manipulations. The MYBPC3 gene was chosen as a candidate gene in this model after identifying a reduction in the protein in myocardium from affected cats in comparison to control cats (P<0.001).

Researchers at Ohio State have identified a single nucleic acid base pair change (G to C) in the feline MYBPC3 gene in affected cats that alters the shape of the protein expressed by this gene and affects its function. A causative mutation in the feline MYBPC3 gene that results in the development of familial HCM has been identified. This is the first report of a spontaneous mutation causing HCM in a non-human species. It provides a valuable model for evaluating pathophysiologic processes and therapeutic manipulations. A test that can screen for the causative mutation for this disease by evaluation of blood samples, buccal swabs or hair samples has been developed.

Potential Applications:

  • Veterinary Medicine
  • Animal Genetics
  • Human and animal Diagnostics

Advantages:

  • Breeders will be able to screen breeding animals before they are used.
  • Test will allow for early diagnosis and early medical intervention, which may lead to a better prognosis overall.

IP Status:

Patent pending.

Methods for Identifying Nucleic Acid Mutations using Mismatch Modification

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Summary:

Researchers at The Ohio State University have developed a method for the rapid and efficient identification of genetic alterations within large fragments of DNA (>3.2 Kb). Genetic alterations form the basis of many cancers and all inherited diseases. In cancer, there is growing evidence that identification of genetic mutations in the early stages of disease could lead to early interventional treatments that have a greater potential to reduce the morbidity and mortality caused by end-stage disease. This method describes a novel procedure to detect mutated DNA using chemical modifications that carry an easily detectable, antigenic marker. These components can be packaged into a molecular diagnosis kit resulting in rapid, efficient and sensitive detection of genetic mutations. Mutations can then be analyzed to determine the degree to which they are disease-related as well as providing a basic research tool for genetic studies. There is a clear need for the development of rapid, reliable, and sensitive methods for detecting point mutations in nucleic acids. It is anticipated that this technology will provide significant improvements to the interdisciplinary fields of mutation detection and genetic screening.

Potential Applications:

  • Early detection and diagnosis of genetically linked diseases.
  • Provides a basic research tool for the study of genetic mutations.

Advantages:

  • It’s non-radioactive, utilizes no harsh or dangerous chemicals, is conducted within a single tube, is extremely rapid, screens tremendously large fragments of DNA and can easily be adapted to automated formats.
  • This method allows for mutations to be identified and segregated from the overwhelming amounts of normal DNA.

Thyroid Cancer Diagnostic

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Summary:

Thyroid cancer has the fastest rising incidence of all organ sites. There are 250,000 preoperative biopsies of thyroid nodules each year in the United States to determine whether the nodule is malignant. The current gold standard for diagnostic purposes is fine needle aspiration (FNA) cytology. Of the 250,000 undergoing FNA cytology, 50,000 are inconclusive, i.e., malignancy cannot be excluded. All of these cases proceed to surgery for conclusive diagnostic purposes. Of these 50,000 that go to surgery, only 20% have a true follicular malignancy (FTC). 80% undergo needless surgery that requires them to take thyroid replacement therapy.

Researchers at The Ohio State University have developed a three gene diagnostic test that can differentiate benign from malignant follicular neoplasias of the thyroid. Results have shown a 97% level of accuracy in diagnosis.

Advantages:

  • Elimination of surgery for 80% of the current inconclusive patients.
  • Test is highly sensitive and specific, superior to other alternatives.

IP Status:

Patent pending

Monoclonal Antibody to Oncofetal Protein for Treating and Detecting Cancer

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Summary:

Researchers at the Ohio State University have discovered a low cost, less toxic, anti-cancer immunotherapy which enhances the host’s immune system’s ability to destroy or contain cancers, and the present invention also provides a diagnostic test for cancer. Specifically, the present invention provides monoclonal antibodies specific for, that is, specifically bind, oncofetal protein (OFP), a cancer cell product. OFP is unique in that OFP is not a structural protein or antigen on the cancer cell surface, rather it is secreted from the cancer cell. Tumors treated with a single dose of the monoclonal antibodies against OFP are markedly reduced in size, and leukemic populations of cells treated with a single dose of monoclonal antibodies against OFP are significantly decreased in number. Since the monoclonal antibodies of the present invention do not bind to tumor cells, the monoclonal antibody treatment overcomes the disadvantages associated with tumor cell targeting. It is believed that OFP is immunosuppressive and by sequestering or removing OFP via the monoclonal antibody, the patient’s immune defense against tumors is released from impairment allowing a more efficient and natural rejection of the cancer. Monoclonal antibodies to OFP offer a simple and inexpensive agent for use as a primary or adjuvant therapy. Moreover, because monoclonal antibodies to OFP do not depend upon binding to a specific tumor cell type, they are effective against a wide variety of cancers and tumors in humans and animals. The monoclonal antibodies against OFP are also employed to detect cancer in animal patients, including human patients.

Potential Applications:

Cancer treatment and detection

Advantages:

  • Low cost
  • Less toxic than other anti-cancer agents
  • Provides a diagnostic test for cancer

A new carbon based electrochemical detector electrode method of making and uses

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Summary:

Researchers at the Ohio State University have discovered a novel way of making electrochemical detector electrodes with an amperometric glassy carbon electrode system. As opposed to traditional pH detector electrodes, these glassy carbon electrodes are made to withstand chemical attacks and remain stable across a large range of pressure, temperature, and pH conditions. Traditional detector electrodes can also be difficult to miniaturize, must be read by expensive meters, not mechanically robust, and can be potentially dangerous when used for food testing in the human body. The glassy carbon electrode system overcomes all the above limitations. Potential uses of these electrodes include industrial process control, analytical chemistry, biomedical monitoring including blood glucose testing, and medical diagnosis.

Potential Applications:

  • Industrial process control
  • Analytical chemistry
  • Biomedical monitoring
  • Medical diagnosis

Advantages:

  • Can withstand large range of pressure, temperature, and pH conditions
  • Easy to miniaturize
  • Mechanically robust
  • Safe to use inside the human body

Modified Serial Analysis of Ribosomal Sequence Tags (mSARST)

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Summary:

Knowledge of bacterial diversity is a critical step in understanding and manipulating microbial communities and processes, ranging from environmental bioremediation to improving human health. Researchers at The Ohio State University have developed a diagnostic tool for identifying diverse bacterial profiles from a wide variety of samples. The method provides both quantitative and qualitative information in a high throughput format. Unlike the current method, the OSU method is easily adaptable to high throughput kit format and can be used to design micro-arrays.

Potential Applications:

  • Characterization of any type of microbial community irrespective of the level of complexity.
  • Comprehensive studies of human gastrointestinal microbiology in support of the prediction and diagnosis of illness and disease.
  • Comprehensive analysis and monitoring of the temporal or spatial changes in microbial diversity in complex natural and managed microbial communities, for quality control and quality assurance purposes.
  • Fundamental studies of microbial ecology.

Advantages:

  • Provides more detailed, rapid and cost effective analysis of bacterial diversity and community structure
  • Offers up to 20-fold increase in throughput

    • Bias and chimera formation associated with PCR-based analysis is minimized.

  • RSTs can be used to design microarrays for further analysis.
  • Procedure can be packaged into a commercial reagent kit.

Immunocorrective Surgery (ICS)

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Summary:

A method is provided for immune corrective surgical removal of lymphoid tissues containing shed tumor antigen in an individual. A detector molecule, with binding specificity for shed tumor antigen, is administered to an individual, and detected in the individual is the presence of lymphoid tissue which contains shed tumor antigen, as detected by the signal emitted by the detector molecule bound to shed tumor antigen. The lymphoid tissue, detected as containing shed tumor antigen, may then be surgically removed, thereby removing B cells, shed tumor antigen, and follicular dendritic cells involved in a pro-tumor immune response that are contained in the removed lymphoid tissue.

Potential Applications:

Treatment of tumors

Advantages:

Enables the identification of lymphoid tissues containing shed tumor antigens for possible surgical removable

Digital Method for Real-Time Frequency Evaluation of Periodic Signals

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Summary:

Frequency counters typically count a frequency of a periodic signal by setting a set gate level. Each time the periodic signal crosses the gate level an event is generated. After calculating the number of events per second, the frequency is then calculated from the periodic signal. Unfortunately, this universal method has not demonstrated stability for frequency measurements. At The Ohio State University, we have created a reliable digital real-time method that detects frequency of a force signal from a microcantilever sensor in Magnetic Resonance Force Microscopy. Additionally, this method demonstrates sensitivity limited only by the displacement noise of a cantilever. Our high precision evaluation of the frequency of a periodic signal can be used as an extra option for any currently available digital signal processing hardware. A prototype is available for testing and evaluation under a confidentiality agreement.

Potential Applications:

  • Detection of biohazards at sensitive immigration and import/export points and at transportation sites
  • Counter intelligence and eavesdropping
  • Breathalizers
  • Any SFM system, MRFM, MRI, and microwave signals

Advantages:

  • Measures frequency shifts of resonator cantilever quickly thus offering increased sensitivity.
  • Continuously measures rather than sampling because it measures in small forces that are 6-7 magnitudes larger than what needs to be measured.
  • Accurately and directly calculates the frequency from the amplitude and the phase of an input signal.
  • The frequency signal is based upon a number of points less than the period of a signal.
  • Enables higher force sensitivity for force microscopy systems and for noise where force is detected through its influence upon the frequency of the oscillating mechanical force detector (microcantilever).
  • Solves the problem of limited bandwidth of amplitude detection.
  • Most effective sound frequency range is DC-1MHz.
  • One can resynchronize by re-inputing data that was taken out of the probe sequence so one can probe the system with the probe sequence.
  • Allows one to create a full MRFM measurement system including a self excitation circuit, a frequency detector, and RF modulation circuits and capable of generating modulation signals whose phase is locked to the cantilever signal.
  • Existing computers already use digital computers.
  • Digital read-out of frequency output time is 4 milliseconds; as computer boards improve, this technique’s speed improves.