Dive Brief:

• The FDA has granted 510(k) clearance to Premier Biotech’s oxycodone and methadone drug screening assays.

• Premier’s OralTox is now cleared to test for eight drugs in saliva samples at the point of care.

• The addition of oxycodone and methadone to the testing suite comes as U.S. regulators and businesses still struggle to contain the opioid crisis.

Dive Insight:

When Premier received FDA clearance for the first version of OralTox in February, there were notable drugs missing from the list of substances the in vitro diagnostic could detect. The device was cleared to screen for opiates but not for the synthetic and semi-synthetic opioids methadone and oxycodone. Given methadone and semi-synthetic opioids such as oxycodone are involved in close to 20,000 overdose deaths a year, their absence from the test list was a notable shortcoming of the device.

Premier has moved quickly to address the gap in its roster of tests, snagging clearance for the methadone and oxycodone assays seven months after securing the original regulatory OK.

The clearances expand the utility of a device Premier hopes will give private employers, government agencies, pain clinics and other organizations a better way to test for illicit substances. Traditionally, these tests were performed on urine samples, making it hard for organizations to observe collection of the fluid without invading the privacy of the person being assessed. The inability to easily monitor sample collection created an opportunity for people to cheat the test.

Recognizing these difficulties, Premier developed OralTox to identify illicit drugs in saliva samples. The person being tested swabs their mouth with the sample collector and waits for saliva to build up in the vessel. Once enough saliva is collected, the vessel is placed into the testing device. The saliva then comes into contact with test strips that display lines to indicate positive or negative results.      

OralTox is now cleared to test for the three types of opioid, plus amphetamine, cocaine, marijuana, methamphetamine and phencyclidine. The device can test for up to 12 drugs at the same time, giving Premier scope to receive regulatory clearances for more assays.