The use of the Presage ST2 Assay to evaluate the prognosis of individuals diagnosed with chronic heart failure is considered investigational.
The use of the Presage ST2 Assay to guide management (eg, pharmacologic, device-based, exercise) of individuals diagnosed with chronic heart failure is considered investigational.
The use of the Presage ST2 Assay in the post cardiac transplantation period, including but not limited to predicting prognosis and predicting acute cellular rejection, is considered investigational.
The measurement of volatile organic compounds to assist in the detection of moderate grade 2R (formerly grade 3) heart transplant rejection is considered investigational.
The use of peripheral blood measurement of dd-cfDNA in the post cardiac transplantation period, including but not limited to predicting prognosis and predicting acute cellular rejection, is considered investigational.
The use of peripheral blood gene expression profile tests alone or in combination with peripheral blood measurement of donor-derived cell-free DNA (dd-cfDNA) in the management of individuals after heart transplantation, including but not limited to the detection of acute heart transplant rejection or heart transplant graft dysfunction, is considered investigational.
The use of peripheral blood measurement of dd-cfDNA in the management of individuals after renal transplantation, including but not limited to the detection of acute renal transplant rejection or renal transplant graft dysfunction, is considered investigational.
The use of peripheral blood measurement of dd-cfDNA in the management of individuals after lung transplantation, including but not limited to the detection of acute lung transplant rejection or lung transplant graft dysfunction, is considered investigational.
