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Understanding Diagnostics 

Effective diagnostic methods are important for early and accurate data collection of patient information to maximize the quality of medical care. New diagnostic methods can accelerate detection or elucidate previously unidentified biological parameters for diseases detection. Non-invasive diagnostic methods are more comfortable for patients, but also require new approaches. Innovative, safe, and cutting edge diagnostic tools and methods are being developed at UMassMed through interdisciplinary collaboration. 




 Browse Our Diagnostics Inventions:




Title: Systems and Methods for Prevention of Pressure Ulcers. UMMS16-69; Patent Pending. 

  • The systems, devices, and methods of this invention provide diagnostic measurements detecting or preventing pressure ulcers. Pressure measurements at body locations are used to determine a diagnostic pressure ulcer value which indicate whether corrective action is needed to prevent pressure ulcer formation. One or more sensor devices can be attached to a patient to measure to transmit data for further processing.

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Title: A Method to Quantify Net Axonal Transport in Motor Nerves. UMMS15-65; Patent Pending. 

  • This invention provides methods of diagnosing motor neuron pathologies either before or after treatment by administering to the subject a radiolabeled agent comprising tetanus toxic C fragment and assessing both transport across the neuromuscular junction and retrograde transport. This novel biomarker system can greatly facilitate the study and treatment of diseases such as ALS.

Title: CARDS: CRISPR Arrayed Repeat Detection System / Part I. UMMS15-58; Patent Pending. 

  • This invention discloses a platform to detect DNA repeat expansions called CRISPR Arrayed Repeat Detection System (CARDS). Utilizing this platform primary cell cultures and/or blood cell smears can be tested under conventional clinical diagnostic laboratory conditions to diagnose genetically-based diseases having DNA repeat expansions, including but not limited to ALS. Further disclosed are dCas9 constructs having fluorescent proteins bound to any or all stem loop sequences, wherein detection of a plurality of dCas9 constructs having different colored fluorescent proteins can simultaneously detect at least six (6) different gene target loci. 

Title: Using Cas9 Coupled Histone Effector to Investigate Enhancer Function. UMMS15-23; Patent Pending.Title: 

  • The invention uses CRISPR targeting to provides a rapid high throughput system to determine the contribution of distal cis-regulatory elements to development and disease. This method is faster and more versatile than using TALE of ZFN effectors. This level of genome control has previously not been achieved with other RNA-guided regulatory technologies such as RNAi.

Title: In Vivo Rechargeable Near Infrared Emitting Mesoporous Persistent Luminescence Nanocomposites. UMMS15-20; Patent Pending. 

  • The invention provides methods to produce novel mesoporous persistent luminescece silica nanoparticles that are uniform and homogeneous for optical imaging applications.

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Title: Diagnostic Test for High Risk Premalignant Breast Lesions. UMMS14-69; Patent Pending.

  • The present invention provides an objective biomarker, SFRP1, for the diagnosis of pre-malignant breast lesions also knows as atypical hyperplasias. The technology also discloses a gene expression profile used for predicting the risk that a pre-malignant breast lesion will advance to invasive breast cancer. Further, methods, assays and kits incorporating the SFRP1 biomarker are provided.

Title: Molecular Diagnosis of FSHD by Epigenetic Signature. UMMS14-65; Patent Pending. 

  • This new diagnostic method for facioscapulohumeral muscular dystrophy (FSHD) using saliva samples, can circumvent the traditional need for fresh blood samples. Many FSHD patients are asymptomatic until disease progression over many years, making initial diagnosis difficult. Even patients found to be positive for FSHD using the DNA testing method be asymptomatic. Building on the discovery that the saliva and muscle epigenetic landscapes are correlated, this invention can provide early and accurate diagnosis of FSHD.

Title: Hyperspectral Imaging for Assessment and Prediction of Thermal Burn Injury. UMMS14-42; Patent Pending. 

  • This innovation addresses the fundamental need to assess early maximal burn depths in burn patients. Early and reliable differentiation between superficial and deep dermal burns is critical for optimizing surgical and resuscitation care. By creating/utilizing a spectral signature of skin, this technology uses non-visible and non-insvasive light to quantify oxy- and deoxy-hemolglobin levels, which can be used to predict thermal exposure.

Title: A New Medical Use of Gadoxetate Disodium to Evaluate Cystic Duct Patency Using CT Scan. UMMS14-33; Patent Pending. 

  • A method of diagnosing a condition in a patient experiencing cholecystitis that uses gadoxeate disodium as a contrast agent for making images such as CT scans of the biliary tree and related anatomical structures. The method uses x-ray radiation generated with excitation voltages in the range of 70 KV to 140 KV. The x-ray radiation is preferably filtered to suppress or practically remove x-rays having energy lower than 50.2 KeV.

Title: REBISS Score and REBISS Score Calculator. UMMS14-32; Patent Pending. 

  • To prevent misdiagnosis, this technology discloses a clinical scoring system that effectively and efficiently utilizes a number of different data sources to determine a diagnosis of patient conditions. The score is compared to a spectrum of scores in order to identify between disorders, such as Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBSd) or gastroesophageal reflux disease (GERD) and functional dyspepsia for which there are currently no validated scoring systems.

Title: Method and Application for Vascular Phantoms. UMMS14-11; Patent Pending.

  • This invention provides a novel method of imaging intracranial atherosclerotic disease (ICAD) by creating a 3D vascular phantom based on imaging data of vasculature of a subject. This technology is non-invasive thereby overcoming the significant risk of morbidity and mortality due to catheter angiography, the current gold standard for imaging ICAD. Further, unlike catheter angiography this technology can provide characteristics of the atherosclerotic plaque, vessel wall and information regarding the underlying etiology.

Title: Method for Efficient Preparation of cDNA Libraries from Small RNAs. UMMS14-04; Patent Pending.

  • A novel method for generating cDNA libraries from unprecedented low quantities (e.g., pg and sub-pg range) of RNA is described herein. Using this method, cDNA libraries can be generated from a range of biofluids as well as from limited tissue volumes isolated from size-limited pathology specimens including biopsy tissue blocks, from small numbers of pure populations of cells isolated from laser capture microdissection of heterogeneous cell populations, and from small numbers of model-organisms. The methods can incorporate one or more novel components including (i) the reduction of gel purification steps, (ii) seamless transition between ligation and RT using sequential reactions in a single tube, and (iii) incorporation of biotinylated nucleotides in the RT reaction to permit efficient purification of cDNA prior to PCR.

Title: Application of Hematocrit/Hemoglobin-derived Correction Algorithm to Whole Blood Platelet Reactivity Tests. UMMS14-02; Patent Pending. 

  • The invention relates to novel methods and assays, which provide accurate and easily implemented measurement and analyses of whole blood platelet reactivity. These assays can be used to identify patients at high risk of thrombotic complications and recurrent ischemic events, especially those with lowered response to clopidogrel. These patients can then be targeted with enhanced anti-platelet therapy.

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Title: Anti-fracCRP Hybridomas and Monoclonal Antibodies. UMMS13-71; Patent Pending. 

  • This invention provides antibodies and antibody fragments that bind to human fractional C-Reactive Protein (fracCRP), kits and assays using these antibodies and antibody fragments to diagnose low to moderate risk for Acute Coronary Syndrome (ACS). This invention is based on two clinical studies (one prospective, one retrospective) that measured fracCRP, Troponin I (TnI), and the fracCRPxTnI metric on 210 patients (105 each with final diagnoses of ACS negative or ACS positive). Overall, the method demonstrated strong diagnostic rule-in value for these patients on arrival, with a specificity of 96.2%, positive predictive value of 91.7%, sensitivity of 41.9%, and negative predictive value of 62.3%.

Title: Chemical Exchange Saturation Transfer Angiography (angioCEST). UMMS13-56; Patent Pending. 

  • The invention provides a novel approach for effective ex vivo and in vivo imaging of blood and establishes the feasibility of blood as an effective agent for Chemical Exchange Transfer Saturation (CEST). The method of the invention is based on the measurement of the labile protons that are associated with various amino acids, proteins, peptides and other molecules that are naturally present in blood. These components are not detectable with currently available clinical MRI sequences, but generate a clear signal by using CEST. MR imaging of blood in vivo remains a major challenge in part because blood flow affects the intensity of MR images in many nonlinear ways that depend both on details of the particular imaging technique and on blood vessel and flow geometry.

Title: Monoclonal Antibodies to sFlt1 and Uses Thereof. UMMS13-51; Patent Pending.

Title: A Novel Biological Imaging Probes: Cascade Sensitization of Tri-doped -NaYF4:Nd,Yb,Er(Tm)/NaYF4 Core/Shell Colloidal Nanoparticles with a Biocompatiable 800 nm Excited Upconverting Luminescence. UMMS13-41; Patent Pending. 

  • The invention provides novel upconverting luminescence materials (e.g., UCNPs) and methods that have constitutional excitation engineered to optimize at about 800 nm, which is not only well away from peak absorption of water, but also is ideally situated at a local minimum of water absorption. A unique class of cascade sensitized tri-doped UCNPs with a biocompatiable 800 nm excitable property are disclosed, for example, tri-doped P-NaYF :Nd,Yb,Er(Tm)/NaYF UCNPs, which employ Nd3+ as 800 nm photon sensitizer and Yb3+ as bridging ions, affording strong green or blue upconversion emissions without photobleaching.


  • This invention is directed to a diagnostic test for identifying individuals with amyotrophic lateral sclerosis (ALS) or individuals who are at risk of developing ALS. This test is based on detecting one or more alterations in a profilin 1 (PFN1) sequence of an individual.

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Title: Apparatus and Method for X-Ray Contrast Imaging. UMMS12-39; Patent Pending. 

  • The invention pertains to an apparatus and method for x-ray phase contrast imaging that uses a scanning interferometer for the x-ray source, source grating, phase grating and detector grating, with the object being imaged stationary.  Importantly, the apparatus and method does not require movement of the phase or detector grating relative to each other, often referred to as phase-stepping. 

Title: Hyperspectral Imaging for Early Detection of Oxygenation and Perfusion Changes in Irradiated Skin. UMMS12-20; Patent Pending.

  • The invention is based on the discovery of hyperspectral imaging-based methods that enable effective, efficient and non-invasive detection and characterization of ionizing radiation exposure in tissue. Methods of the invention allow for complete visualization and quantification of oxygenation and perfusion changes in irradiated skin. The invention enables rapid identification of individuals exposed to ionizing radiation after a radiological attack or accident. Methods of the invention can offer quantitative metrics to identify people exposed to higher doses of ionizing radiation well before the appearance of any dermal injury and permit appropriate triage to healthcare facilities.

Title: Capseq - an Enzymatic Method to Enrich and Deep-seq Capped RNA. UMMS12-18; Patent Pending.

  • This invention discloses novel methods for the enzymatic enrichment and detection of RNA 5' ends that eliminates contaminating RNA sequences and dramatically enriches for RNAs that contain the nuclease resistant 5' cap structure.  The invention avoids the tedious and inefficient column purification procedure and can clone mRNA from as little as 500 ng. The cloned sequences are anchored at the 5' end of capped RNAs thus simplifying the bioinformatics analysis to compare samples.


  • The invention provides novel biocompatible upconversion nanoparticles (UCNP) comprising a core of cubic nanocrystals (e.g., comprising α-Na Lna, Lnb Lnc F4) and an epitaxial shell (e.g., formed from CaF2; wherein Lnb is Yb). The disclosed nanoparticles lack the toxicity of traditional UCNPs and are synthesized in a single reactor vessel making them more amenable to large-scale production. Further provided are methods of whole body imaging and photochemical methods using the disclosed nanoparticles. 


  • This technology discloses polymer conjugated gold nanoparticles with increased stability and biocompatibility for use in imaging, diagnostics, and drug delivery.

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Title: Cancer Associated PcG (CAP) Bodies as a Cancer Biomarker. UMMS11-51; Patent Pending. 

  • The invention features methods of diagnosing cancer by detecting a biomarker selected from a satellite II ribonucleic acid (RNA) molecule, a cancer-associated polycomb group (CAP) body, a cancer-associated satellite transcript (CAST) body, and UbH2A. Also featured are methods of using these biomarkers to identify therapeutic cancer agents. Further, this invention provides methods to determine whether chemotherapeutic agents alter epigenetic imbalance in cells by determining a copy number of a satellite II DNA locus at chromosome 1q12.

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  • This invention discloses antibodies that bind to human fractional C-Reactive Protein (fracCRP), kits containing these antibodies and antibody fragments, and assays using these antibodies and antibody fragments to assess patients at low to moderate risk for Acute Coronary Syndrome (ACS). Overall, this method demonstrated strong diagnostic rule-in value for these patients, with a specificity of 96.2%, positive predictive value of 91.7%, sensitivity of 41.9%, and negative predictive value of 62.3%. 

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  • This invention discloses methods and compositions to detect Toll-like receptor (TLR) binding to ligands and evaluate compound for screening. Using different biosensor complexes, this technology enables the diagnosis of gram positive or negative infections in a human subject. Each platform utilizes a TLR conjugated to a biosensor that detects a single TLR-ligand binding domain complementary to its cognate ligand. This technology can provide a method to select appropriate treatment for a patient with inflammatory and possibly other conditions.


  • This patented invention provides methods for detecting the presence of replication-competent HIV-1 virus in a subject who is being treated with an intensified highly active anti-retroviral therapy (HAART) regimen. These methods comprise obtaining a blood sample, specifically amplifying a segment spanning two-long terminal repeat (2-LTR) junction of 2-LTR circles using PCR and determining the presence of replication competent virus based on the level of 2-LTR circles in the sample. These methods can be used to monitor an intensified HAART regimen by obtaining samples from the same subject at different time points during the HAART treatment, and comparing levels of the 2-LTR circles in those samples.

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  • This invention builds on the existing non invasive spectroscopic sensor that can detect information from tissues of different thicknesses to aid diagnoses. This invention uses a mathematical approach to calculate capillary SO2, pO2, pH, pCO2, and temperature. The calibration equation for all parameters uses PCA Loading Correction factor to account for subject-to-subject variation that has been used to determine the calibration equation.


  • This invention provides a new protocol to describe long range physical interaction of genome loci within and between chromosomes. Long range regulatory elements in the genomes are known to interact. This interaction is important for genome biology, as it can control aspects of the genome, such as stability and dosage compensation. Contrary to the previous methods for describing long range genome interactions, Hi-C does not require prior understanding of one genomic loci, making it a truly genome wide characterization. This invention may reveal important aspects of genomic interaction in disease. 

Title: SPECTROSCOPIC SENSORS. UMMS08-39; Patent 9,095,291. 

  • This technology is a miniature sensor optimized to collect spectra from the tissue of living subjects. The device accommodates tissues of different thicknesses with just a single sensor. The devices are made of solid state materials that are easy and inexpensive to manufacture. The broad spectrum of readings can detect oxygen tension, pH, hematocrit and potentially more parameters.

Title: Detection of Human Immunodeficiency Virus. UMMS08-36; Patent Pending. 

  • This new PCR based assay can detect cells that have been recently infected by HIV, even those that may not typically be detectable while the patient is under aggressive antiretroviral therapy. In peripheral blood lymphocytes, this method detects circular viral DNA in individuals infected with HIV. This detection method has been found effective even when plasma viral RNA levels are undetectable under conventional HIV RNA-PCR testing. Research on this method also revealed that the currently implemented treatment with antiretroviral agents does not completely abolish the viral infection, providing an opportunity for further innovation in HIV management.

Title: Monoclonal Antibody Producing Cell Lines called 2C3-like Cell Lines and the 2C3-like Antibodies that They Produce. UMMS08-34; Patent Pending.

  • This new invention spans from the discovery of novel antibodies and an antigen binding fragment that bind surface membrane proteins of Neisseria species (e.g. N. gonorrhoeae and N. meningitidis). This invention can be applied to diagnostic, therapeutic, and potentially preventative methods for managing Neisseria infections.


  • This innovation provides a method to assess acute tissue damage and stratify acute coronary syndrome. Analysis of circulating C-reactive protein (CRP) and fractional forms of CRP (fracCRP), permits early measurement of tissue damage than fracCRP values only in a specific diseases context previous inventions, thus, broadening the scope of application for this established laboratory value.  of the use of fraCRP values. This process provides a method for a more comprehensive analysis of acute tissue damage that may be applicable to a variety of clinical scenarios.


  • This new invention predicates on the finding that midbody (MB), a singular organelle formed between daughter cells during cytokinesis required for separation, are inherited asymeetrically by daughter cell of stem cells and cancer ‘stem cells’. The new methods disclosed in this invention can modulate degradation.

Title: sST2 Dengue Virus Diagnostic. UMMS08-12; Patent Pending.

  • This invention uses interleukin-receptor like 1 protein (sST2) level to diagnose Dengue fever, infection with Dengue virus. Clinical symptoms of dengue infection are difficult to recognize and most individuals are asymptomatic or have only mild fever. This new technology addresses the need for a more effective diagnostic tool, capitalizing on the understanding that sST2 levels are elevated with in dengue virus infection when compared to uninfected patients. sST2 is further elevated during secondary infection, so this marker may serve to identify severity of infection.