"Given the small number of patients involved in T315I CML and...

"Given the small number of patients involved in T315I CML and the absence of a drug product for T315I-CML and the ASR-1 rules, there has been no commercial reason for any group to seek formal FDA clearance for these tests. No commercial reason to submit anything to FDA's
Centre for Devices and Radiological Health (CDRH)."

"If FDA Approval of a T315I test is required for Omapro marketing, it is likely that a sponsor (Molecular MD, Quest etc) would pursue a Humanitarian Device Exemption
(HED), a special form of FDA clearance for tests that diagnose diseases that affect fewer than 4,000 individuals per year. HED applications are exempt from the
effectiveness requirements of a Pre-market approval (PMA), and formal clinical trials are not required. HED applications must contain sufficient information for FDA
to determine that the test does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or
illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. FDA's CDRH would be the body that ultimately considers such applications, if necessary."