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FDA Expedited Mpox Test Kit Registration Announced by Lertchai Lertwut Amid Rising Global Concerns

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FDA Registration(Photo: Reuters)

The Food and Drug Administration (FDA) has officially opened registration for monkeypox (mpox) diagnostic test kits, as concerns about the spread of this viral infection continue to rise. Lertchai Lertwut, the FDA’s deputy secretary-general, announced on Thursday that the agency is streamlining the registration process for both manufacturers and importers.

Mr. Lertchai emphasized that this move aims to fast-track approval, ensuring that these test kits become available as swiftly as possible while maintaining public health security. More detailed information about the FDA-approved test kits can be found at FDA’s website.

Manufacturers and importers of mpox test kits have been advised to consult the FDA’s guidelines for product registration before submitting their applications. This proactive approach by the FDA comes in the wake of a recent declaration by the World Health Organization (WHO), which labeled a new strain of mpox, specifically the Clade 1b-type, as a “public health emergency of international concern” after cases emerged in over 10 African countries.

Dr. Darinda Rosa, the acting director of the Office of Disease Prevention and Control 11 of Nakhon Si Thammarat, stated that the WHO is deeply concerned about the new strain’s higher transmissibility compared to previous variants. As of the latest reports, over 15,600 individuals worldwide have been diagnosed with the new mpox strain, and unfortunately, 537 of those cases have resulted in fatalities.

Focusing on Thailand, Dr. Darinda revealed that from January 1 to August 17, 142 individuals have been diagnosed with the new mpox strain. Tragically, three lives have been lost to the disease within the kingdom. In response to this alarming situation, the Department of Disease Control has implemented stringent screening measures at major international airports, including Don Mueang and Suvarnabhumi airports, as well as Laem Chabang Port, primarily targeting passengers arriving from Africa.

This calculated and vigilant approach aims to curb the spread of this new and more infectious strain of mpox. With the streamlined registration and availability of test kits, collaborative international efforts, and rigorous screening protocols, public health authorities are stepping up their game to protect individuals both locally and globally.

37 Comments

  1. Laura Smith August 23, 2024

    I’m glad the FDA is fast-tracking these test kits. We need to act quickly to contain this outbreak.

    • Alan King August 23, 2024

      Absolutely! But I hope they maintain strict quality controls. A faulty test kit could do more harm than good.

      • Laura Smith August 23, 2024

        True, Alan. Quality is crucial, but given the urgency, some compromise might be inevitable.

      • sciencegal August 23, 2024

        Compromise shouldn’t mean substandard safety. Lives are literally on the line.

    • Tim16 August 23, 2024

      Why is the focus only on Africa? There could be unreported cases elsewhere.

  2. mike_s August 23, 2024

    Another virus scare. Remember when we freaked out over Ebola? How did that turn out?

    • Kimberly August 23, 2024

      Ebola was contained due to quick responses. We can’t be complacent about mpox just because past efforts worked.

    • Jane D. August 23, 2024

      It’s better to be safe than sorry, Mike. These precautions can save lives.

    • mike_s August 23, 2024

      I get it, but the media always hypes these things up. I’m just skeptical.

  3. Raj Patel August 23, 2024

    What about poorer countries? Will they get access to these test kits, or will this be another scenario where wealthier nations hoard resources?

    • Lauren W. August 23, 2024

      I hope global health organizations ensure equitable distribution. Poorer nations already suffer enough.

    • Raj Patel August 23, 2024

      It’s an ongoing issue. Wealthier countries need to step up.

    • Jake85 August 23, 2024

      Easier said than done. Geopolitics always gets in the way.

  4. Shannon August 23, 2024

    How effective are these test kits against the new strain? That’s what I want to know.

    • DoctorRay August 23, 2024

      The kits are designed to detect known strains. Rapid mutation can be problematic, but regular updates to the kits can address this.

    • Sarah Go August 23, 2024

      It’s scary how adaptable viruses can be. Constant vigilance is necessary.

  5. Tommy T. August 23, 2024

    I hope this doesn’t lead to more lockdowns. My business barely survived the last round.

    • Becca R. August 23, 2024

      Unfortunately, public health has to come first. But governments should offer more support to affected businesses.

    • Gary_23 August 23, 2024

      It’s a tough balance. Protecting lives while sustaining livelihoods.

    • Tommy T. August 23, 2024

      Absolutely, Gary. Not just about health; it’s about preventing financial ruin too.

  6. Educator123 August 23, 2024

    I’m concerned about how this affects schools. We can’t keep disrupting children’s education with every new virus.

  7. Lance B. August 23, 2024

    It’s good to see an international effort. We need to work together to beat this.

    • Hopefulfuture August 23, 2024

      Collaboration is key. No single country can handle this alone.

  8. Eva Green August 23, 2024

    Shouldn’t we also focus on vaccination? Test kits are only part of the solution.

    • Caleb H. August 23, 2024

      Vaccines are important, but developing them takes time. Test kits help in immediate detection and control.

    • Eva Green August 23, 2024

      True, but investment in vaccine research should parallel these efforts.

  9. Skeptic999 August 23, 2024

    How do we know this isn’t just another ploy by Big Pharma to make money?

    • Marie L. August 23, 2024

      It’s normal to be skeptical, but public health crises need swift action. Not everything is a conspiracy.

    • James P. August 23, 2024

      Exactly, Marie. The focus should be on saving lives, not profit motives.

    • Skeptic999 August 23, 2024

      We’ve been burned before. Profits often come before people. Gotta question everything.

  10. travelbug99 August 23, 2024

    What about travel restrictions? Are we looking at bans again?

    • Wanderlust August 23, 2024

      Hopefully not! But measures at airports seem reasonable given the situation.

    • John T. August 23, 2024

      Better safe than sorry. Targeted restrictions might be necessary to control the spread.

  11. LittleJoe August 23, 2024

    I heard mpox is less deadly than other viruses. So why the big fuss?

  12. Jenny August 23, 2024

    What about the environmental impacts of producing millions of test kits? We always overlook that.

    • EcoWarrior August 23, 2024

      Excellent point, Jenny. Medical waste is a huge issue. Sustainable practices should be part of the plan.

  13. Ben Francis August 23, 2024

    The number of fatalities is alarming. We need to prioritize health over everything else.

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