LOS ANGELES — PASS has officially certified, for the first time, a lab specializing in home-collection clinical tests: BasisDx.
BasisDx’s Pro13 Kit includes all tests required for regular PASS clearance. The kit carries out 13 assays for HIV 1/2 Ag/Ab, HIV PCR, hepatitis B, hepatitis C, syphilis, trichomoniasis, MGen; pharyngeal, rectal and genital chlamydia; and pharyngeal, rectal and genital gonorrhea.
Retailing for $199, the kit comes with a guaranteed 48-hour turnaround from sample receipt in the lab. In some areas, results will come with physician-guided individual treatment plans.
The Pro13 kit's security features include a prerequisite televisit for first-time users, tamper-proof seals for the prepaid return kit, and an option to use the BDx Molecular Profile to scientifically validate that samples come from the specified user.
PASS Executive Director Ian O’Brien said, “At-home collection and testing has long been a goal of ours, and we are elated to finally have found a partnership that can meet the industry’s specific testing and security requirements. With BasisDx coming on board, PASS-certified testing is now available across the USA.”
BasisDx Laboratory Director and founder Dr. Andreas Kogelnik said, “This is a monumental step forward for public sexual health. We are thrilled to be the first company to offer PASS-certified home collection and testing kits. Getting approved for PASS certification hinged on a lot of hard work and novel innovation. We developed and adapted collection methods suitable to a home-collection setting and worked alongside FDA-approved instrument makers to shrink and automate processes wherever possible without sacrificing the quality of each test.”
The new Pro13 Kit is available to purchase from BasisDx.org.