Abbott received approval from the US Food and Drug Administration (FDA) for its HIV Combo Next Assay on June 29, 2026. The regulatory clearance, granted under the 510(k) pathway, allows the company to market the diagnostic assay in the United States. The specific submission reference number for the approval is BK261345.

Regulatory Details

The FDA determined that the HIV Combo Next Assay is substantially equivalent to a predicate device, facilitating its clearance through the 510(k) process. This pathway is generally used for devices that demonstrate safety and effectiveness by comparing them to already legally marketed devices.

Product Information

Abbott has signed a licensing agreement with ALZpath, a provider of blood-based diagnostics for Alzheimer's disease, for its proprietary phosphorylated Tau 217 antibody. The agreement aims to enhance the accessibility of high-performance testing for clinicians and patients globally. The pTau217 antibody is among the most clinically validated for detecting Alzheimer's disease pathology, backed by more than 200 peer-reviewed publications across 18 countries. It demonstrates high accuracy and sensitivity in identifying Alzheimer's disease biology.

The partnership addresses the growing need for scalable diagnostics as disease-modifying therapies expand. ALZpath's pTau217 antibody provides a less invasive and more cost-effective alternative to PET imaging and cerebrospinal fluid (CSF) analysis, which are often difficult to deploy at scale. Blood-based biomarkers are also expected to play a role in monitoring disease progression and treatment response in routine clinical practice.

Strategic Implications

Mike Banville, CEO of ALZpath, stated that the agreement reinforces the company's leadership in blood-based Alzheimer's testing. He noted that partnering with a global healthcare leader like Abbott enables high-performance testing to reach a wider audience. The collaboration focuses on integrating the antibody into routine care, including primary care settings, to assist patients in need.

Abbott's Commitment to Brain Health

John Frels, vice president of research and development in Abbott's Core Diagnostics business, highlighted the company's decade-long focus on advancing brain health science. Abbott previously pioneered the first FDA cleared rapid blood test for assessing mild traumatic brain injuries using objective biomarker data. Frels emphasized that such collaborations accelerate research, clinical trials, and patient care in Alzheimer's disease.