Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the
 "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for
 developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV)
 administration of Bisphosphonates (BP).
The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which
 may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following
 IV administration of drugs of the Bisphosphonate family.
Inclusion Criteria:

 Inclusion Criteria Study Group (all of the following):

 1. Subject is ≥18 years old

 2. Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV
 treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was
 a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the
 BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as
 sodium alendronate, and in the opinion of the PI, IV treatment was significant enough
 to be considered as the cause for BRONJ

 3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS
 (American Association of Oral and Maxillofacial Surgeons)

 4. Subject has signed the informed consent or consent can be waived

 Inclusion Criteria Control Group (all of the following):

 1. Subject is ≥18 years old

 2. Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been
 IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two
 (2) years (continuously or cumulatively)

 3. Subject has not developed any signs or symptoms of BRONJ

 4. Subject has signed the informed consent or consent can be waived

 Exclusion Criteria:

 1. Subject has been treated with irradiation to the jaws or head and neck at levels
 exceeding 35 Gy

 2. Pregnant or lactating women

 3. Subject has been treated with either bevacizumab or sunitimib

 4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation
 (HSCT)