Manufacturer Doesn’t Expect Zika Blood-Screening Test Shortage

US FDA has asked Miami-area blood banks to close until they can screen all blood supplies for the Zika virus in the wake of the first known cases transmitted by mosquitos within the US. A manufacturer of the only test currently available for blood-bank use does not expect shortages, despite the increased demand.

The manufacturer of the only Zika blood screening test on the US market doesn’t expect mandatory Zika virus screening at Miami-area blood banks to cause any short-term Zika test shortages.

Hologic Inc. co-developed the Procleix Zika, which runs on the Procleis Panther system, with Grifols SA. FDA cleared the Zika assay in June via an investigational new drug (IND) exemption, making it the first and only test on the market with an indication for screening donated blood

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from In Vitro Diagnostics

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By 

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By 

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

More from Diagnostics

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By 

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

Danaher Faces $350M Tariff Hit, But Says It’s Ready To Absorb The Blow

 
• By 

Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.

What’s A Diagnostic? WHO Wants To Know

 
• By 

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.