This story has been updated with a correction. The company has clarified that it is raising $15 million rather than the $25 million it had initially told 360Dx.
NEW YORK – University of Maryland spinout Astek Diagnostics aims to launch by late 2025 a point-of-care infection test system to determine within an hour whether a patient has a urinary tract infection and which antibiotics are likely to be effective for treatment.
While the fluorescence-based optical test system isn't used to identify the type of bacteria that is causing an infection, the company said that the test results could be used to help healthcare providers avoid ineffective prescriptions for first-line antibiotics.
Astek CEO Mustafa Al-Adhami said that the firm is focused on commercializing its cartridge-based Jiddu benchtop analyzer targeting urology practices while it continues the development of tests for different sample types. The company has already inked contracts worth $30 million for the delivery of tests to urology practices once the firm receives US Food and Drug Administration marketing clearance for its testing system, he said.
In an award abstract for a $992,000 Small Business Innovation Research Phase II grant from the National Science Foundation, Astek said that its testing technologies could help to reduce patient morbidity and mortality through rapid diagnosis and more targeted treatment of UTIs, urosepsis, meningitis, and wound infections. The firm also received SBIR Phase I grants of $256,000 in 2021 and $295,000 in 2023.
Astek's test is an adaptation of the resazurin colorimetric assay, which is used to determine cell viability for various applications such as assessing the cytotoxicity of drug candidates, environmental monitoring, and, for decades, testing for contamination in milk. Resazurin tests have long been used to measure cell viability through the conversion of the weakly fluorescent blue dye resazurin into the highly fluorescent pink resorufin.
Astek's analyzer, dubbed Jiddu, and its cartridges incorporate automated microfluidic sample processing. A single-excitation and single-emission fluorometer is used to detect fluorescence, and software is used to interpret the results. The firm reported early this year that it had extended its research partnership with Maryland-based MedStar Health Research Institute on their work to improve the underlying technologies of the Jiddu analyzer and develop it for clinical use.
Astek's test filters bacteria from a sample, suspended in growth media, and distributes the sample into seven channels, of which two are for positive and negative controls and five are for antibiotic resistance testing. After 35 minutes of culturing, the bacteria are moved into analysis chambers and mixed with resazurin dye.
Fluorescence is measured to determine the metabolic activity of viable bacteria in the seven chambers. Patients with at least 100,000 colony-forming units per milliliter are deemed to have an infection, and the amounts of fluorescence in the five drug resistance testing chambers are used to determine whether the bacteria remained viable in the presence of antibiotics.
Al-Adhami said that Astek's UTI test achieved 95.6 percent accuracy in a pilot study that the firm conducted in 2022 through a collaboration with the University of Maryland School of Medicine. He said that the firm challenged the test with more complicated samples from patients with neurogenic bladder dysfunction, and the test performance declined to 90.5 percent accuracy during testing in 2023 before bouncing back to 93.8 percent accuracy in subsequent tests starting late last year after the firm adjusted the algorithm that is used to analyze the results.
Al-Adhami noted that the results suggest which antibiotics will be effective against a whole microbial community, which could contain multiple pathogens. He also said that the company plans to develop various panels for use in different geographic areas and patient populations.
Infectious disease physicians may still want to perform the test along with other tests to identify the causes of infections, genetic mutations in those bacteria, and potential outbreaks, Al-Adhami said, adding urologists want a test that quickly delivers antibiotic sensitivity information even if it doesn't identify the pathogens.
Astek, which is based in the Baltimore area, licensed its testing technologies from the University of Maryland, which received patent No. 11,788,962, titled "Method and apparatus for rapid detection of bacterial contamination" in October 2023. The patent states that various bacteria can be detected using the testing system such as Escherichia coli, Listeria monocytogenes, Salmonella, Vibrio cholerae, and Shigella.
Al-Adhami, who is listed as one of the inventors on the patent, said that he began working on the testing technology as a graduate student in hopes it could aid the identification of cholera contamination in drinking water sources and reduce the toll of recurring outbreaks. However, the widespread availability of water filters in recent years has diminished the need for such tests.
He and fellow researchers continued developing the technologies with a goal of creating a blood-based test that could help to identify sepsis and other bacterial infections as well as provide antibiotic resistance data, but Al-Adhami learned that bringing that test to market would have involved a difficult and costly regulatory process.
Instead, the company shifted its focus toward urine-based testing after his grandfather received multiple ineffective antibiotic treatments for a urinary tract infection. He said that two treatments failed during the four days before culture-based test results were available to aid the selection of an effective therapy. Al-Adhami’s grandfather survived but the painful, prolonged illness left him weakened.
Al-Adhami noted that the UTI test kit will also be easier to develop and bring to market than a blood-based test. The urine-based test kit has lower complexity and could be regulated as a Class II moderate-risk device in comparison with a Class III high-risk blood-based test, he said.
He noted that FDA officials said in a pre-submission meeting that the firm would need to seek de novo marketing authorization, which will require more clinical trials than would be needed if the technologies were eligible for 510(k) clearance.
According to Al-Adhami, Astek's test delivers answers faster and at lower cost than PCR-based panels that are used for the simultaneous identification of the causes of infections and likely antimicrobial resistance.
Labs also have recently described struggles to secure reimbursement for multiplex molecular panels as those tests have gained ground in infectious disease testing.
In the meantime, other players in the space include Swedish firm Sysmex Astrego, which has developed a competing point-of-care UTI test, although Al-Adhami said that Astek has an advantage because its test can be performed up to eight hours after sample collection whereas Sysmex's PA-100 AST System requires testing within 30 minutes of sample collection. Sysmex officials did not respond to requests for comment.
Llusern Scientific has taken a different approach by developing a rapid loop-mediated isothermal amplification test to detect and identify the causes of UTIs while Microplate Dx has developed a rapid antibiotic susceptibility test to guide therapy selection in patients with suspected UTIs.
OpGen said last year that it had submitted a de novo classification request to the FDA for a highly multiplexed PCR-based panel for the detection in urine of bacterial and fungal pathogens along with antimicrobial resistance markers.
Al-Adhami said that the firm hopes to bring its UTI test to market by Q4 2025, although he said that is an aggressive target, and the firm may not be able to commercialize the platform until 2026. The firm also set targets of commercializing its cerebrospinal fluid-based meningitis test in 2026, effluent-based wound infection test in 2027, and blood-based sepsis and bacterial infection test in 2028.
Al-Adhami said that the company is planning to sell its analyzer at cost for $6,500 and tests for $50 each in a razor-razor blade model. The firm plans to apply for reimbursement in the range of $100 to $250 per test and hopes to receive a CPT code by the second quarter of 2027.
He noted that Astek has raised $7.6 million so far and hopes to raise another $15 million through an upcoming Series A funding round.