Home Testing SIG

Join top experts to discuss FDA’s proposed amendment to bring laboratory-developed tests (LDTs) under the same regulatory process as in-vitro diagnostic devices (IVDs). Leveraging decades of experience, our speakers will shed light on what’s motivating these amendments, what they would mean for laboratories, regulatory bodies, and the patients they serve, and how interested laboratories, device companies, and health care providers might prepare for the change.

The Home Testing SIG brings together medical, scientific, technology solution, laboratory and regulatory experts to address barriers to adoption and to accelerate use of home testing as a part of virtual care.

Some of the questions we’ll be addressing: What are the barriers? Does a lack of a common industry language around home testing slow down adoption? Do the lack of specific performance requirements contribute to a lack of clarity in regulation and limited reimbursement? What can industry do to help accelerate home testing adoption by better connection to telehealth solutions?