IMMY, a medical technology manufacturer, has been awarded a 3-year, $1.5 million National Institute of Allergy and Infectious Disease (NIAID) contract for developing and validating a talaromyces point-of-care (POC) test.
Endemic in Southeast Asia, talaromycosis is an invasive mycosis spread through airborne inhalation of Talaromyces marneffei fungal spores from the environment. Talaromycosis kills up to one in three affected individuals with a compromised immune system and is a leading cause of death in individuals with advanced HIV disease in Southeast Asia.
Talaromycosis diagnosis currently depends on culture and histopathological evaluation, which both require expertise and laboratory capacity that do not exist outside of major hospitals in the region. These cultures take up to 14 days and are positive only during late stages of infection. An accurate POC talaromyces test would enable doctors in most areas to diagnose the disease and enable early antifungal therapy.
IMMY developed a talaromyces lateral flow assay (LFA) prototype with NIAID funding in 2020. The talaromyces LFA’s technology requires minimal technical expertise or laboratory equipment and can provide results in as little as 15 minutes.
The NIAID contract aims to fully validate an easy-to-use POC diagnostic capable of early, rapid detection of talaromyces antigens in human urine. Once the manufacturing processes for the device are brought to scale and validated, IMMY will work with Duke University School of Medicine researchers on the studies necessary to receive regulatory approval for the device.
HOUND LABS, QUEST DIAGNOSTICS PARTNER ON CANNABIS BREATH TEST
Hound Labs has announced an agreement with Quest Diagnostics that establishes Quest as the exclusive provider of laboratory services for confirmatory testing of positive breath sample results generated by the Hound Cannabis Breathalyzer.
The device is intended to detect and deter cannabis use during the workday. Conventional cannabis testing methods for oral fluid, urine, and hair have windows of detection extending to days, weeks, or months after use, but Hound’s test isolates detection of tetrahydrocannabinol (THC) to hours after use and automatically processes results on-location within minutes. Negative test results indicate an employee is not likely to have used cannabis immediately preceding or during the workday.
Under the agreement, Quest will use its own recently developed and validated mass spectrometry technique to confirm positive results from the Hound breathalyzer. Quest’s new technique is designed to match the level of sensitivity developed by Hound Labs to detect THC.
Hound Labs officials noted that cannabis legalization and a tight labor market has prompted some employers to reconsider their workplace cannabis testing policies, driving a need to determine when an employee has used cannabis.
DISTRIBUTION AGREEMENT FOR MONKEYPOX REAL-TIME PCR DETECTION KIT
Virax Biolabs has announced a distribution agreement to market Monkeypox Virus Real-Time PCR detection kits with Cosmos Holdings. Under the agreement, Cosmos will have exclusive distribution rights for Greece and Cyprus, with the opportunity to distribute the test kits across Europe on a nonexclusive basis.
The test is intended to aid in the rapid diagnosis of the monkeypox virus in human serum and lesion exudate specimens, providing a preliminary test result. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
Virax officials said the agreement will facilitate the rapid diagnosis, treatment, and containment of monkeypox infection, which had been reported in 104 countries as of early September 2022. Officials added that they are working to establish additional regional partnerships across the globe.
Cosmos officials said they see strong demand for fast testing methods for monkeypox and view the current agreement as a first step in a longstanding relationship with Virax.
AGREEMENT TO RESULT IN NEW HLA TYPING KIT
GenDx has announced an agreement with Oxford Nanopore Technologies to bring its new NGS-Turbo kit to the transplant market for fast, high-resolution human leukocyte antigen (HLA) typing.
According to GenDx, the NGS-Turbo has the ability to obtain results in less than 4 hours. Due to time constraints, HLA typing of solid organs, such as kidneys, is typically restricted to low-resolution results. The new product enables improved matching of solid organs in situations where time is a critical factor, GeneDx said.
The company added that it intends to start an early-access program consisting of a fast amplification of all 11 HLA loci using a whole-gene approach with its NGS-Turbo Amp technology. After the subsequent quick library preparation on the NGS-Turbo Prep, a sample can be sequenced on Oxford Nanopore sequencers and the data can be directly analyzed and typed with the NGSengine technology. NGS-Turbo is an expansion of GenDx’s current high-resolution HLA typing portfolio.
RQM+ BUYS JORDI LABS
RQM+, a medical technology provider, recently announced the acquisition of Jordi Labs.
The acquisition allows RQM+ to offer proprietary testing services for extractables and leachables, which the company says will allow its customers a faster path to regulatory approvals.
Jordi Labs provides chemical characterization and complex product deformulation as well as contaminant and failure investigations to medical device manufacturers. Their team of analytical chemists uses a proprietary, multidetector approach to ensure that all extractables are accurately characterized to comply with regulatory requirements for global materials testing.
CARB-X AWARDS DAY ZERO DIAGNOSTICS WITH $8.2 MILLION
Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded Day Zero Diagnostics with $8.2 million in funding to support product development of infectious disease rapid diagnostics. CARB-X initially awarded Day Zero with $6.2 million in 2020 and has continuously added monetary awards bringing the total of the grant to $16 million.
Founded in 2016, Day Zero has led research and development of genome sequencing and machine learning-based approaches against antibiotic-resistant infections. Currently, the company is developing whole-genome sequencing-based diagnostic technology to identify pathogen species and antibiotic resistance profiles from a blood sample within hours.
Additionally, the companies hope to launch an in vitro diagnostic instrument and cartridge system that has been cleared by the Food and Drug Administration and CE marked. According to the companies, the system will provide a sample-to-answer solution that incorporates DayZero’s Blood2Bac technology, a proprietary sample preparation technology for ultra-high enrichment of bacterial DNA from clinical blood samples, and Keynome, a machine learning algorithm for species identification and resistance profiling.
Day Zero was winner of the 2021 AACC Disruptive Technology Award for its DZD OneSeq Dx technology.