Carlsbad, CA — March 20, 2026 — Qualigen Diagnostics, part of the Biosynex Group, today announced a new agreement with Afaxys GPO, a specialized purchasing organization serving public health providers, to expand access to quantitative hCG testing using the FASTPACK® IP System across women’s health settings in the United States.
Under the agreement, eligible Afaxys members will have access to Qualigen Diagnostics’ FASTPACK® IP quantitative hCG assay, performed on a compact, automated immunoassay analyzer that delivers laboratory-quality quantitative results in approximately 12 minutes from serum or plasma samples. This enables providers to obtain timely diagnostic information to support pregnancy confirmation and patient management during the clinical visit.
“Access to reliable quantitative hCG testing remains essential in women’s health,” said Steven Sepulveda, Chief Strategy Officer, Biosynex US. “Through our agreement with Afaxys, we are expanding availability of FASTPACK® IP technology to providers seeking rapid, quantitative results that support clinical decision-making during the patient visit.”
By enabling quantitative pregnancy testing to be performed directly within the clinical setting, the FASTPACK® IP System can help reduce reliance on laboratory send-out testing, support faster clinical assessment and patient counseling, and improve workflow efficiency.
This agreement reflects the continued commitment of Qualigen Diagnostics and Biosynex to improving access to timely diagnostic solutions that enhance clinical workflow efficiency and support patient care across decentralized healthcare environments.
About FASTPACK® IP System (Qualigen Diagnostics)
The FASTPACK® IP System is a compact, fully automated quantitative immunoassay analyzer designed for use in decentralized and near-patient clinical settings. Utilizing single-use test pouches containing integrated reagents, the system delivers laboratory-quality quantitative immunoassay results in approximately 12 minutes using serum or plasma samples.
In addition to quantitative hCG, the FASTPACK® IP menu includes assays supporting women’s health, hormone monitoring, and wellness testing, including testosterone, SHBG, PSA, thyroid function tests, and vitamin D.
About Qualigen Diagnostics
Qualigen Diagnostics develops and commercializes diagnostic solutions designed to support timely, clinically actionable testing across decentralized care settings. Its portfolio includes quantitative immunoassay systems and assays supporting women’s health, hormone monitoring, and chronic disease management. Qualigen Diagnostics is part of the Biosynex Group.
For more information, visit www.qualigendiagnostics.com
About BIOSYNEX
Founded in 2005, the French laboratory Biosynex Group is a leading health diagnostics group specializing in rapid tests, biotherapy monitoring, and molecular biology. BIOSYNEX develops and commercializes diagnostic solutions for laboratories, hospitals, physicians, and patients worldwide.
Based in Illkirch-Graffenstaden, Alsace, the BIOSYNEX Group employs over 500 people and has a presence in 95 countries. The Group achieved a turnover of €93 million in 2023. Listed on Euronext Growth Paris (FR0011005933 ALBIO), BIOSYNEX is eligible for PEA-PME.
For more information, visit www.biosynex.com.
