The fastest rapid dual test for HIV and syphilis is now available in Australia, expanding access to reliable and accessible screening.

A Major Step Forward in Infectious Disease Screening

• The INSTI® Multiplex HIV-1/2 Syphilis Antibody Test delivers highly accurate results in just 60 seconds with a single sample—the fastest dual HIV/syphilis rapid test available.
• Now included in the Australian Register of Therapeutic Goods (ARTG number: 482706), available to healthcare professionals nationwide.
• A portable and shelf-stable screening option designed for clinical and outreach settings.
• Expanding access to rapid testing supports Australia’s public health goals to reduce HIV and syphilis transmission.
• Clinically validated with industry-leading sensitivity and specificity.
• Manufactured under bioLytical’s MDSAP/ISO 13485:2016 certified Quality Management System.

bioLytical Expands Rapid Testing Access in Australia

RICHMOND, British Columbia, March 18, 2025 (GLOBE NEWSWIRE) -- bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid infectious disease diagnostics, announces the launch of its INSTI® Multiplex HIV-1/2 Syphilis Antibody Test in Australia. Now included in the Australian Register of Therapeutic Goods (ARTG number: 482706), this dual HIV-syphilis test provides results in just 60 seconds, helping healthcare professionals diagnose HIV and syphilis efficiently and connect patients to care faster.

“Access to fast, reliable rapid testing is critical to eliminating infectious diseases as public health threats,” said Robert Mackie, CEO of bioLytical. “We’re proud to bring our dual HIV-syphilis test to support Australia’s public health initiatives. We know that expanding access to testing enables faster diagnoses and plays a key role in reducing transmission and improving treatment outcomes. We remain committed to offering a vital tool for healthcare professionals in Australia and worldwide.”

With its rapid results and ease of use, the INSTI® Multiplex Test is a valuable resource for clinics, hospitals, and outreach programs, particularly in communities with limited access to laboratory testing. By increasing access to early and reliable detection, the test aligns with Australia's national STI screening and public health strategies.

Why Rapid HIV and Syphilis Testing Matters

HIV and syphilis continue to pose significant public health challenges in Australia:

• 722 new HIV diagnoses were reported nationally in 2023, up from 553 in 2022, though overall trends remain lower than pre-pandemic levels.
• An estimated 30,000 people are currently living with HIV in Australia, underscoring the importance of accessible testing.
• Syphilis infections were recorded in almost every region in 2023, reinforcing the need for increased screening.
• Both HIV and syphilis can be asymptomatic in early stages, making regular testing essential to prevent further transmission.

The INSTI® Multiplex HIV-1/2 Syphilis Antibody Test is already used in other global markets, such as Canada and across Europe, with Health Canada authorization and its CE Mark, respectively. This contributes to improved testing accessibility and early diagnosis initiatives. Expanding availability in Australia helps more individuals learn their status quickly and access care.

Fast, Reliable, and Easy to Use

The INSTI® Multiplex HIV-1/2 Syphilis Antibody Test requires just a single drop of fingerstick blood. It provides highly accurate results in 60 seconds – helping healthcare professionals reach more people and connect them to treatment and care while working to reduce onward infections.

Key Benefits:

• Ultra-fast: Results in just 60 seconds—the fastest dual HIV/syphilis rapid test available.
• Highly accurate: Clinically validated with industry-leading sensitivity and specificity.
• Portable and shelf-stable: Ideal for both clinical and outreach settings.
• Supports immediate patient engagement: Ensures individuals receive care without delay.

Where to Access the Test

The INSTI® Multiplex HIV-1/2 Syphilis Antibody Test is now available for professional use across Australia. Healthcare providers can contact bioLytical or authorized distributors for purchasing details.

A New Era in Infectious Disease Screening

“With rapid results for both HIV and syphilis, this test helps healthcare professionals diagnose infections faster and connect patients to care sooner,” said David Weaver, VP of Commercial, bioLytical. “By simplifying the screening process and reducing delays, we are making reliable and accurate testing more accessible and improving health outcomes across Australia.”

bioLytical’s Commitment to Public Health

bioLytical manufactures the INSTI® Multiplex HIV-1/2 Syphilis Antibody Test in its MDSAP/ISO 13485-certified facility, ensuring the highest quality standards. As a global leader in rapid infectious disease diagnostics, bioLytical operates in over 70 countries and is dedicated to expanding access to fast, accurate, and reliable testing solutions worldwide.

About bioLytical Laboratories Inc.

bioLytical Laboratories Inc. is a privately held Canadian company focused on researching, developing, and commercializing rapid diagnostic tests. Utilizing its proprietary INSTI® technology platform and lateral flow line, iStatis, bioLytical delivers real-time, highly accurate results that empower medical professionals, patients, and public health organizations worldwide. As a global leader in rapid diagnostics, bioLytical continues to build solutions that improve global health outcomes.

For more information, visit www.biolytical.com, www.insti.com, and www.istatis.com.

For Journalists:

For interview requests or additional data on HIV and syphilis testing, contact press@biolytical.com.

Sources:

• Australian Government Department of Health and Aged Care: Australia’s Syphilis Epidemic
• Australian Government Department of Health and Aged Care: National Syphilis Surveillance Report (2024)
• UNAIDS: HIV/AIDS Data for Australia
• UNSW Kirby Institute: Annual Surveillance Report (2024): HIV
• UNSW Kirby Institute: Annual Surveillance Report (2024): Sexually Transmitted Infections
  

Media Contact: Stephanie Ritchie Communications Specialist, bioLytical press@biolytical.com +1-778-238-9340