Astek Diagnostics and Other Baltimore-based Medtechs are Developing Creative Diagnostic Solutions to Better Detect Disease, Including UTIs

By Alex Keown
May 9, 2023

Urinary tract infections (UTI) are a common condition affecting more than one million people in the United States each year. However, if these infections are untreated, they can evolve into complicated UTIs. These complicated infections are associated with high mortality rates among critically ill patients.

Current UTI testing methods take two days to identify the specific bacteria present and the appropriate antibiotic for treatment. During that time, the untreated infections can worsen and lead to additional complications, Mustafa Al-Adhami, PhD, chief executive officer of Astek Diagnostics told BioBuzz.

Dr. Mustafa Al-Adhami, Astek Diagnostics CEO (SOURCE: Astek Diagnostics)

Al-Adhami explained that when a patient visits a doctor to treat a urinary tract infection, “it’s typically a guess” as to which antibiotic will work best. To address these concerns, Baltimore-based Astek Diagnostics, which launched in 2020 and received support from TEDCO, developed Jiddu, a benchtop analyzer that can identify the presence of a bacterial infection in urine and then perform antibiotic susceptibility testing (AST) of the bacterium within one hour. Jiddu is designed to inform treating physicians which antibiotics would likely be the best to prescribe to patients. The one hour time frame will allow patients to be treated quickly and avoid worsening symptoms, Al-Adhami added.

Astek’s Jiddu, named for Al-Adhami’s grandfather who suffered from a complicated UTI, is capable of determining an antibiotic sensitivity in one hour, informing treating physician’s which medication is the best to prescribe. Data from a recently completed pilot study with the Department of Medicine at the University of Maryland School of Medicine showed a 95% sensitivity and 92% specificity, Al-Adhami said, adding that the strong results were pleasantly surprising.

 “I believe Jiddu has the potential to revolutionize UTI diagnosis and treatment,” he said. “Not only does it show high efficacy, it’s also easy for clinicians to use. And, it provides a better alternative to traditional UTI testing.”

Image of Astek’s Jiddu Device (SOURCE: Astek Diagnostics)

The Jiddu is a benchtop analyzer made up of two distinct parts through microfluidics – a separation chamber and analyzer. The bacteria is first isolated from urine in the separation chamber, and then metabolic activity is measured through an ultra-sensitive detector using fluorescent dye. This enables physicians to determine antibiotic susceptibility.

“Any bacteria in a sample origin can be studied,” Al-Adhami said. “It’s a very simple approach.”

Astek’s Jiddu could see regulatory approval for urine testing within a year and a market launch sometime in 2024. Additional approvals for analyses conducted with blood and spinal fluids could come within the next few years, Al-Adhami said.

In addition to Astek Diagnostics, Baltimore is home to a thriving community of similar companies, some of which are featured below.

Pearl Diagnostics

Located in the Johns Hopkins Fast Forward Accelerator in Baltimore, Pearl Diagnostics is focused on development of diagnostic products to enable early detection and prevention of lung infections, particularly those caused by fungi. People who receive organ transplantation, cancer therapy and medications to suppress the immune system have risks for infections caused by fungi.

Pearl’s first product, a urine test to detect fungal infections in the lung, is in clinical studies now. The test relies on monoclonal antibodies produced to Aspergillus conidia in order to detect small molecular weight galactofuranose-containing Aspergillus antigens in urine. The test has already been cleared for marketing in Europe.

xMD Diagnostics

Molecular diagnostics tools company xMD Diagnostics develops precise microdissection technology for diagnosis of cancer and other genetic diseases with increased resolution, accuracy and speed.

The company’s technology, dubbed Expression Microdissection, allows for the isolation and enrichment of cells of interest, including malignant cells from biopsies and other specimen samples. This allows downstream PCR, genomic/proteomic, NGS and molecular testing for histology and cytology specimens, according to the company. xMD believes its technology has the potential to improve diagnoses results. 

“Expression microdissection, therefore, represents the first enabling step in the molecular pathology workflow, and is crucial to procuring the necessary quality and quantity of cells/DNA/RNA and  for molecular testing.”

Accelevir Diagnostics

The Accelevir team develops digital PCR workflows supporting clinical programs. Digital PCR is uniquely adapted to the performance demands of current molecular assays across infectious disease and oncology, the company said. Its PCR platform is optimized for robust performance with a multitude of sample types, including blood, tissue, and cell-free nucleic acids. The company’s PCR tests are broadly used to support HIV-1 clinical trials. On its website, Accelevir notes its growing portfolio includes proprietary and non-proprietary assays for pathogen quantification and human gene mutation detection. Accelevir leverages short and long-read sequencing technologies to develop impactful and novel testing solutions.

Additionally, Accelevir provides a wide variety of virologic techniques including: viral titer, primary viral isolate culture, quantitative viral outgrowth assays, in vitro infectivity assays, custom viral assay development, and custom viral construct development. The company offers both high-throughput and small scale specialty cellular processing services.

Sonavex Inc.

Privately-held Sonavex, a spinout of Johns Hopkins, has developed a portfolio of novel ultrasound solutions. The Sonavex EchoSure system is designed to enable any member of the care team to collect arteriovenous fistula volumetric flow rate, diameter and depth information at the dialysis clinic to assist with maturation assessment, according to the company.

The company’s EchoSure system, which received FDA 501(k) clearance in 2019, combines 3D ultrasound imaging with advanced deep learning algorithms to automate visual and quantitative blood flow monitoring following surgery.

EchoSure works in tandem with Sonavex’s EchoMark soft tissue marker. EchoMark and EchoMark LP (Low Profile), which both received 501(k) clearance in 2019, are “highly echogenic, resorbable polymeric implants used for marking soft tissue sites in surgical patients.”