SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a major step forward against Antimicrobial Resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic assays: NG-TEST®Candida auris and NG-TEST®Acineto-5®. The designation recognizes technologies with the potential to address life-threatening conditions and significant unmet medical needs.
Both tests target pathogens classified as critical priorities by the World Health Organization (WHO). Candida auris, listed in the WHO Fungal Priority Pathogens List (2022), is a multidrug-resistant yeast responsible for hospital outbreaks worldwide. It is often difficult to detect and associated with high mortality. Carbapenem-resistant Acinetobacter baumannii (CRAB), included in the WHO Bacterial Priority Pathogens List (2024), is among the most dangerous hospital-acquired bacteria due to its resistance profile and rapid transmission in healthcare settings.
NG-TEST®Candida auris is the first rapid lateral flow immunoassay specifically designed to identify C. auris from cultured samples in 15 minutes. Published data demonstrate 100% concordance with reference methods across diverse isolates, supporting its role in outbreak investigation and infection control.
NG-TEST®Acineto-5® detects and differentiates five major carbapenemase families—OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM—directly from Acinetobacter samples, also delivering results within 15 minutes. The PCR-free assay is designed for ease of use, without specialized equipment.
"These breakthrough designations validate both the technology behind our assays and the real-world need they address," said Milovan Stankov-Pugès, CEO, NG Biotech.
"The designation underscores the growing urgency around rapid detection of multidrug-resistant organisms that pose serious risks in healthcare settings," said Andre Hsiung, Chief Scientific Officer of Hardy Diagnostics.
Developed and manufactured in France by NG Biotech, the assays are distributed exclusively in the United States by Hardy Diagnostics. They are currently available for Research Use Only while FDA review continues.
By accelerating detection of high-risk pathogens, these breakthrough-designated tests aim to strengthen surveillance, guide infection control decisions, and support global efforts to fight antimicrobial resistance.
Learn more about NG Biotech
Learn more about Hardy Diagnostics
Media & Contact Information
NG BIOTECH
Atelier Relais Le Tremplin
Parc d'Activités de Courbouton, Secteur 1
35480 Guipry, France
+33 (0)2 23 30 17 83
Ms. Pauline Cognet
p.cognet@ngbiotech.com
www.ngbiotech.com
HARDY DIAGNOSTICS
1430 West McCoy Lane
Santa Maria, CA 93455, USA
(805) 346-2766 ext. 5598
Ms. Megan Maloney Roesner
RoesnerM@hardydiagnostics.com
www.HardyDiagnostics.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
HONG KONG, Feb. 18, 2026 /PRNewswire/ -- Tonight (18 February) Hong Kong celebrated the arrival of the Chinese New Year with the spectacular "Prosperity Gallops Across Hong Kong" Year of the Horse Fireworks Display, exclusively sponsored by The Hong Kong Jockey Club (the Club). Meanwhile, there was a drone and fireworks show in Conghua, Guangzhou, also supported by the Club. Both shows are part of the Club's Year of the Horse campaign, a year-long celebration of the special role of horses and horse racing in our community.
In Hong Kong, the 23-minute firework extravaganza opened with a vibrant burst of fireworks to welcome the Year of the Horse. The dazzling display featuring horse-themes and auspicious symbols to extend blessings for the new year. Horseshoes, as well as "HKJC" and "WIN" designs, lit up the night sky, creating a powerful and majestic atmosphere that evoked galloping horses. A total of 31,888 pyrotechnic shells were launched, illuminating Victoria Harbour to spectacularly welcome the Year of the Horse.
Enjoying the fireworks were guests at a special ceremony hosted by the Club at the Hong Kong Convention and Exhibition Centre. Officiating at the ceremony, HKSAR Chief Executive The Hon John KC Lee said this year marks the start of the country's 15th Five-Year Plan, and Hong Kong will continue its relentless efforts in pursuing reform and progress while proactively aligning with the Plan. Hong Kong will also actively integrate into the overall national development strategy, and leveraging its distinctive advantages – strong support from the country and close connections to the world under "One Country, Two Systems" – to contribute to the country's high-quality development. He thanked The Hong Kong Jockey Club for sponsoring tonight's fireworks display, bringing blessings and joy for the Year of the Horse. He wished the motherland prosperity and strength, and Hong Kong a flourishing economy.
The Hon Martin Liao, Chairman of The Hong Kong Jockey Club, said the Year of the Horse is an especially auspicious year for the Club. The city's status as a world leader in horse racing and the on-going development of equestrian sport are sources of immense pride. The Club has launched the Year of the Horse campaign, which includes sponsoring the Year of the Horse Fireworks Display, to honour the horse and the sport that has contributed to the progress and betterment of our city, and to share the festivities with local residents and visitors from around the world. "The Hong Kong Jockey Club's sole purpose is to act continuously for the betterment of our society. Besides providing world-class horse racing and horse sports entertainment, we are entrusted by the Hong Kong SAR Government with channelling gambling demand to combat the illegal market. Through this integrated business model, we are able to generate significant economic value and employment, with our surplus going back to the community through charity donations. We have grown to become one of the largest charity benefactors globally, with our sole focus on Hong Kong. Yet none of this would be possible without the horse." he said.
Spectators in Conghua, Guangzhou enjoyed a no less dazzling display, solely supported by the Club from the first day of Chinese New Year (17 Feb) to today. Around 1,200 drones combined with fireworks to fill the night sky with lively horse racing imagery and symbols of good fortune, heralding a prosperous and joyful year ahead.
Looking forward, one of the key highlights of the Year of the Horse campaign will be the start of world-class racing at the Club's Conghua Racecourse in Guangzhou in October. This will be a significant milestone in the Club's support for national equine industry development in the Greater Bay Area and beyond.
The Year of the Horse campaign unites the community through thrilling races, international equestrian spectacles, and a special series of cultural, sporting and family events. It is a community celebration, a tourist attraction and an opportunity to promote equine and community sports development. For more information please visit https://hkjc.com/YOTH.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Jockey Club lights up the night sky as Hong Kong and Guangdong gallop into the Year of the Horse
Jockey Club lights up the night sky as Hong Kong and Guangdong gallop into the Year of the Horse
Jockey Club lights up the night sky as Hong Kong and Guangdong gallop into the Year of the Horse
Jockey Club lights up the night sky as Hong Kong and Guangdong gallop into the Year of the Horse
