LOS ANGELES, Calif. – BasisDx, a federally approved leading laboratory specializing in home-collect clinical tests, has announced that its new STI-testing kit has “made history by receiving the widely recognized PASS (Performer Availability Screening Services) certification.”
This marks the first time a self-testing STI kit has been certified by PASS. In the announcement, the company called the move “a major milestone for sexual health, making the process of STI checks more convenient and private, with rapid results available across the USA at a low cost.”
The PASS Certification board officially certified BasisDx’s new home-collect Pro-13 testing kit “after meticulous evaluation and testing procedures,” according to the statement issued today.
“This certification has long been used to protect adult industry workers, and now anyone using the home-collect testing kit can benefit from the accuracy, reliability, and, most importantly, the safety the certification offers,” BasisDx noted in the announcement.
According to the statement released today, 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, however typically closer to 24 hours.” In some areas, results will “come with physician-guided, individual treatment plans.”
“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,” said PASS Executive Director Ian O’Brien. “With BasisDx coming on board, PASS-certified testing is now available across the USA.”
The new Pro13 kit offers “enhanced security features, including 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.”
“This is a monumental step forward for public sexual health,” said Dr. Andreas Kogelnik, Laboratory Director and Founder of BasisDx. “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. Together with a leading IT and customer service team, we are disrupting the way STI testing has been done, enabling more people to be tested at a higher quality and lower cost while keeping everyone safe and healthy.”
The new Pro13 Kit is available to purchase from BasisDx.org. For sales inquiries, please contact sales@basisdx.org.
