Pharmaceutical Executive Daily: FDA Grants Emergency Use Authorization to Allplex Assay

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In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.

FDA has granted emergency use authorization to Seegene USA's Allplex assay, the first multiplex PCR test authorized in the U.S. to simultaneously detect and differentiate HSV-1, HSV-2, varicella-zoster virus, and monkeypox virus in a single reaction. The four pathogens often produce lesions that look identical, so testing for just one at a time can leave the others undiagnosed. In a prior clinical evaluation, applying multiplex testing to samples that had already returned negative results under single-pathogen methods still uncovered dozens of missed infections. The authorization builds on Seegene's earlier FDA clearance for a two-target HSV assay and expands the company's footprint in U.S. syndromic testing.

In a conversation with Pharmaceutical Executive, Dr. Gurinder Sidhu, Pfizer's U.S. antiviral medical lead, pushed back on clinician complacency around Covid-19 antivirals as hospitalization rates have declined from early pandemic levels. He noted that roughly 75 percent of American adults still qualify as high-risk due to age or underlying conditions, and that CDC estimates put U.S. hospitalizations between 380,000 and 540,000 for the year spanning October 2024 through September 2025. Sidhu pointed to Paxlovid's narrow five-day treatment window as a key reason clinicians shouldn't wait to see how symptoms progress before prescribing. He also addressed persistent barriers to access, including cost and lingering hesitancy tied to viral rebound concerns.

Finally, Nuvation Bio president and CEO David Hung notes how the company's mission centers on developing more effective and tolerable drugs rather than adding to already crowded treatment categories. He pointed to Ibtrozi, the company's ROS1 inhibitor for non-small cell lung cancer, which has shown a 90 percent response rate, and to safusidenib, an investigational IDH1-targeted therapy for glioma showing durable responses in both low- and high-grade tumors. Hung also outlined the company's drug-drug conjugate platform, which fuses two small molecules together as an alternative to traditional antibody drug conjugates, with a first program expected to be announced later this year.

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