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 test offering, myTAIHEART, is for cardiac transplant patients. The current gold standard surveillance test for these patients is the endomyocardial biopsy, a procedure that is invasive, subject to sampling error, and expensive for both the patient and the healthcare system.

myTAIHEART was designed to meet these clinical needs. The assay requires only a small blood sample and is available to adult and pediatric patients rapidly post-transplant. The myTAIHEART Assay 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, the histological changes of organ rejection are irregularly distributed within the heart tissue, therefore biopsy samples can fail to sample affected regions. This leads to the dangerous potential for false negative biopsy results and undiagnosed graft rejection.

Biopsies remain the standard of care in allograft monitoring largely because noninvasive alternative options have major limitations that diminish their value in clinical practice. myTAIHEART is a direct measurement of organ injury, as opposed to an immunological gene expression profiling test which evaluates the transcription of genes mediating immune processes presumed to indicate rejection. myTAIHEART can be used as soon as one week after transplantation, during a clinically critical risk period for transplant rejection. In addition, myTAIHEART is the first non-invasive organ specific rejection monitoring test that can be used in heart transplant recipients as young as 2 months of age. The limitations of currently available technologies leave crucial unmet needs in the field of organ transplant surveillance that the myTAIHEART assay is designed to address.

 

 

Cell-Free DNA Testing

In all people, cell-free DNA (cfDNA) is released into the bloodstream as a product of natural cell turnover or injury by illness or trauma. In transplant recipients, cfDNA is also released by the cells of the transplanted organ. The “donor specific” cfDNA released by the transplanted organ is genetically distinct from the “self specific” cfDNA released by the recipient’s native cells. The fraction of the recipient’s total cfDNA that is donor specific is known as the donor fraction.

Research by TAI Diagnostics indicates that the donor fraction is a sensitive indicator of the health of the transplanted organ. During rejection, the cells of the transplanted organ are injured disproportionately by the recipient’s immune system compared to native recipient cells, thereby increasing the donor fraction.

Previous studies in a cohort of pediatric and adult heart transplant patients demonstrated the correlation between the donor fraction and transplant rejection. Subsequent research has lead to the development of TAI’s novel, highly accurate quantitative genotyping technique that precisely quantifies the donor fraction in a cost-effective and timely manner for pediatric and adult patients.

 

 

Assay Validation

myTAIHEART is performed in a highly-controlled environment within our CLIA compliant and CAP accredited clinical reference laboratory. Clinical and analytical studies have demonstrated the assay’s ability to generate precise, highly reproducible results, backed by correlation with clinical presentation and biopsy results. Additional multicenter clinical studies are currently underway.

 

 

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 our 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.

Contact

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