Biopool International Receives FDA Approval for New Chemistry Reagents

Strategic Insights -

Biopool International, a company specializing in in vitro diagnostic tests, has received approval from the US Food and Drug Administration (FDA) to market its two new chemistry reagent systems: Alkaline Phosphatase and Aspartate Aminotransferase. These tests are designed to diagnose liver dysfunction and complement the company's existing range of six clinical chemistry reagents that have already received FDA approval.

The approval marks a significant milestone for Biopool, which is targeting the $10-$12 billion worldwide in vitro diagnostic market. Clinical chemistry reagents represent a $2-billion market segment, and Biopool's products are sold globally through a network of distributors to hospitals, clinical, and reference laboratories.

Key Takeaways:

  • Biopool International has received FDA approval to market two new chemistry reagent systems: Alkaline Phosphatase and Aspartate Aminotransferase.
  • These tests are used to diagnose liver dysfunction and are part of the company's existing range of six clinical chemistry reagents.
  • The approval marks a significant milestone for Biopool, which is targeting the $10-$12 billion worldwide in vitro diagnostic market.
  • Clinical chemistry reagents account for $2 billion of the market segment.
  • Biopool's products are sold globally through a network of distributors to hospitals, clinical, and reference laboratories.
  • The company has been developing these products since at least 1987.
  • Biopool has exhibited its products at MEDICA, one of the largest annual trade shows, with over 105,000 attendees and 2,000 exhibitors.

Statistics:

  • $2 billion: the size of the clinical chemistry reagents market segment.
  • $10-$12 billion: the size of the worldwide in vitro diagnostic market.
  • 105,000: the number of attendees at theMEDICA trade show.
  • 2,000: the number of exhibitors at the MEDICA trade show.
  • 1987: the year Biopool International was founded.

Sources:

  • [Biopool International, Inc. (PRNewswire)]
  • [Biopool International, Inc. announcement, Dec. 5, 1995]