Bio-Rad Announces FDA Approval of QXDx AutoDG ddPCR System for Precision Monitoring of Leukemia Treatment Response

VCBeat (WeChat Official Account: vcbeat) has learned that Bio-Rad Laboratories (NYSE: BIO or BIOb), a global leader in life science and clinical diagnostic products, announced on February 15, 2019, that its QXDx AutoDG ddPCR System had received approval from the U.S. Food and Drug Administration (FDA), marking it as the first digital PCR product to gain FDA approval.

The QXDx AutoDG ddPCR System combines the company’s droplet digital PCR technology with the QXDx BCR-ABL %IS Kit, marking Bio-Rad’s first use of liquid biopsy and droplet digital PCR technology for diagnostic purposes. According to the company, the combined use of droplet digital technology and the kit facilitates reproducible and precise monitoring of molecular responses to treatment in patients with chronic myeloid leukemia (CML).

Chronic myeloid leukemia (CML) is a type of white blood cell cancer characterized by the fusion of the BCR and ABL genes. Currently, treatment with tyrosine kinase inhibitors (TKIs) has transformed CML into a manageable chronic disease. The standard method for monitoring treatment response in CML patients is reverse transcription quantitative PCR (RT-qPCR); however, this approach may yield variable results. In contrast, the QXDx BCR-ABL %IS Kit for the QXDx AutoDG ddPCR System received CE marking in late 2017. It quantifies BCR-ABL fusion transcripts, particularly the p210 transcript, and detects residual disease levels in patients undergoing TKI therapy. For instance, measuring residual BCR-ABL levels in CML patients treated with the first-line TKI imatinib can help physicians determine whether it is necessary to initiate second-line TKIs such as dasatinib, nilotinib, or bosutinib.

On the other hand, digital PCR-based methods can provide higher sensitivity than standard RT-qPCR. Bio-Rad’s new assay can detect molecular responses below MR 4.7 (limit of detection, LOD), equivalent to approximately 0.002% on the International Scale. According to the company’s website, a BCR-ABL transcript level between 0.01% and 0.001% defines a deep molecular response, which can more accurately predict long-term outcomes.

Furthermore, the QXDx AutoDG ddPCR System features a flexible design that allows users to run either FDA-approved in vitro diagnostic tests or laboratory-developed tests (LDTs) on the platform. Bio-Rad introduced Droplet Digital PCR (ddPCR) technology to the market as a research tool in 2012, and it was rapidly adopted for liquid biopsy and rare mutation detection in clinical cancer research. The ddPCR product portfolio offers reproducible, absolutely quantitative, precise, sensitive, and scalable workflows. To date, more than 3,400 publications have cited Bio-Rad’s ddPCR technology, including over 900 focused specifically on liquid biopsy.

Bio-Rad also disclosed that the company intends to develop assays for liquid biopsy and other applications, while continuing to strengthen its focus on minimal residual disease monitoring.

Bio-Rad, founded in 1952, is a life sciences company headquartered in California. With a global team of more than 6,500 employees, the company serves over 85,000 research and industry customers worldwide through its operational network. Since its inception, Bio-Rad has built strong customer relationships that facilitate scientific research and development efforts and support the introduction of new technologies in evolving fields such as genomics, proteomics, drug discovery, food safety, and medical diagnostics.

For over five decades, Bio-Rad has played a leadership role in advancing scientific discovery by providing a broad range of services and innovative tools to the life science research and clinical diagnostics markets.

(Compiled by Ning Chen)