As with any other tissue bank, donors are tested for HIV, HTLV, Hepatitis B, Hepatitis C, Syphilis and CMV. Unlike other laboratories, Kimera Labs goes above and beyond the FDA requirements for viral testing by testing for Zika, CMV, EBV, Hepatitis E, HBV, HCV, HIV, HHV6, HHV7, HHV8, HSV1&2, HTLV1, HTLV2, BKV, and Norovirus after production of its exosomes, under quarantine, and prior to release. Beyond this type of screening, placental tissue and mesenchymal stem cells
are not a natural reservoir for any of these types of viruses, so the chance of contamination of the MSC cultures is vanishingly small. Any risk of viral contamination is virtually eliminated during the MSC culture and exosome purification process. Sterility and endotoxin assays are performed at the final stage of production to ensure that there are no infectious agents in the final product.