Monitoring the Health of Transplanted Organs

TAI Diagnostics, Inc. is a biotechnology company focused on providing a non-invasive and highly sensitive diagnostic test to monitor the health of transplanted organs in patients who have received solid organ transplants.

The Clinical Need for
Monitoring Transplant Patients

Rejection is the major cause of transplant failure, and transplant recipients require lifelong rejection surveillance to guide modulation of immunosuppressant dosage and frequently require clinical interventions to improve organ function. Our initial test offering will be for cardiac transplant patients. The current gold standard surveillance test for these patients is the endomyocardial biopsy with histological interpretation by a pathologist, a procedure that is invasive, subject to sampling error, and expensive for both the patient and the healthcare system.

TAI Diagnostics has developed a proprietary noninvasive assay which utilizes patent-pending cf-DNA technology as a direct measurement of organ injury through quantitation of donor-specific cf-DNA released into the bloodstream from injured cells of a transplanted organ. The Quantitative Genotyping Assay requires only a small blood sample for processing in our CLIA certified and CAP accredited clinical reference laboratory. Scientific data to date indicates that the quantitative genotyping technique has a high degree of sensitivity and specificity, a rapid turnaround time, and can be offered at a very competitive price point.

Science

Conventional Screening

The standard of care in the surveillance of cardiac allograft rejection remains catheter-based endomyocardial biopsy (EMB). To detect rejection early, surveillance biopsies must be performed at regular intervals; however, EMB is both expensive and invasive.  Furthermore, organ rejection is a “patchy” process, and biopsy samples can fail to sample small patches of rejection, leading to the dangerous potential for false negative biopsy results and undiagnosed graft rejection.

Biopsies remain the standard of care in allograft monitoring largely because other options have major limitations that diminish their value in clinical practice. Alternative non-invasive transplant monitoring tests do exist that measure gene products present in blood related to the immune response to a transplanted organ, but all such tests on the market suffer from limited positive predictive value and cannot be used until months after transplant, missing the most clinically critical, highest-risk period for transplant rejection. The limitations of currently available technologies leave crucial unmet needs in the field of organ transplant surveillance that the Quantitative Genotyping Assay is designed to address.

 

Cell Free DNA Technology

All people have “self-specific” cf-DNA released into the bloodstream by their own cells as a product of natural cell turnover or injury by illness, such as infection. In transplant recipients, “donor-specific” cf-DNA is present in the blood in addition to self-specific cf-DNA. Donor-specific cf-DNA is released by the transplanted organ and has the genotype of the organ donor, distinct from the recipient’s native genotype. Our test, through quantitative genotyping, can discriminate “self-specific” cf-DNA from “donor-specific” cf-DNA, which originates specifically from the transplanted organ and proportionally increases in the bloodstream of the recipient during transplant rejection as the cells of the transplant are injured by the recipient’s immune system. We previously published a pilot study in a cohort of pediatric and adult heart transplant patients utilizing a novel, highly accurate approach which precisely quantifies the amount of donor specific cf-DNA in recipient plasma. Further research by TAI Diagnostics has strengthened this evidence.

 

Clinical Validation

The Quantitative Genotyping Assay is performed in a highly-controlled environment within our CLIA certified and CAP accredited clinical reference laboratory. Continuing analytical studies demonstrate the assay’s capacity to generate precise, highly reproducible results even in early stages of transplant rejection, backed by correlation with clinical presentation and biopsy results. A multicenter prospective clinical study for cardiac transplant monitoring funded by the NIH/National Heart Lung and Blood Institute and by TAI Diagnostics, Inc. is also underway, and additional studies in lung, liver, and kidney are planned.

 

Peer Reviewed Scientific Publications and Presentations

1. Hidestrand M, Tomita-Mitchell A, Hidestrand P, et al. Journal of the American College of Cardiology. 2014 Apr; 63(12):1224-1226

2. Hidestrand M, Stokowski R, Song K et al. Fetal Diagn Ther. 2012 Mar; 31(2):122-128

3. Wagner A, Mitchell M, Tomita-Mitchell A. Clin Perinatol. 2014 Dec;41(4):957-66

4. Castleberry C, Hidestrand M, Tomita Mitchell A, et al. ISHLT 31st Annual Meeting and Scientific Sessions, April 13-16, 2011, San Diego CA.

5. Hidestrand M, Zangwill S, Tomita-Mitchell A. Journal of Heart and Lung Transplantation. 2012 Apr; 31(4): S91-S92

6. Hidestrand P, Hidestrand M, Stamm K, et al. ISHLT 33rd Annual Meeting and Scientific Sessions, April 24-27, 2013, Montreal QC.

7. Mitchell M, Hidestrand P, Simpson P et al. The Journal of Heart and Lung Transplantation. 2015 Apr; 34(4):S53

About the Company

TAI Diagnostics is committed to bringing its life-changing new technology to the transplant surveillance market.  The company is headquartered in the Milwaukee County Research Park adjacent to the Medical College of Wisconsin, Blood Research Institute, and Milwaukee Regional Medical Center.

Leadership

TAI Diagnostics is led by a team of healthcare professionals and executives with decades of experience committed to developing cell-free DNA technology for better clinical outcomes.

News and Events

  • TAI Diagnostics Closes $8.2M Series A Financing

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Contact

TAI Diagnostics, Inc.
10101 Innovation Drive
Suite 600
Milwaukee WI, 53226
Phone: (414) 831-9970
Email: info@taidiagnostics.com
TAI Diagnostics