In June the American Association of Clinical Chemistry (AACC) announced the finalists for their 2022 Disruptive Technology Award. The competition recognizes innovative technologies and solutions that can improve diagnostic performance or access to testing. All three nominees represent exciting advances and demonstrate how far the clinical diagnostics industry has come. As we continue to address the challenges brought on by the COVID-19 pandemic, it is an opportune moment to showcase some of the technological advances that have the potential to shake up the industry and will hopefully yield new discoveries down the line.
Simplified, noninvasive cancer screening
The Verita Isolation Platform is a lab-on-a-chip platform designed for minimally invasive diagnostic assays that detect biomarkers in biofluids. The team behind the platform (Biological Dynamics), seeks to change how cancer is managed to not only treat patients when symptoms appear, but also at earlier stages. The Verita platform is unique in that it requires no sample preparation, has codetection of multiple classes of biomarkers, and has a dramatically simplified workflow that enables viable multi-omic testing for many applications. Additionally, Verita’s novel methodology takes advantage of electrochemical engineering to isolate biomolecules from blood to identify early signals of tumor presence.
The goal of this combination of biotechnology and medicine is to make simplified, noninvasive cancer screening the standard health care practice for everyone. Currently, Biological Dynamics is working to build a multi-cancer test that can be used during annual screenings anytime a patient visits their doctor. Their hope is that with this technology, more cancers will be caught earlier and at more treatable stages.
Point-of-care women’s health
The molecular diagnostics company Nanopath aims to improve the lives of patients, for the moment focusing on women, by supplying molecular information after a single visit to a health care provider. To this end, Nanopath has developed a solid-state biosensing platform that takes advantage of ultrasensitive optical detection of genetic information, eliminating the need for nucleic acid amplification. According to Nanopath, their platform can provide actionable genetic information in less than 15 minutes. This new technology has filled a market gap in the women’s health space, where traditional tools are ill equipped to address the health care needs of women. The Nanopath platform’s advanced technology also allows for complex testing at the point of care.
Nanopath indicates that, as of publication, the platform has provided preliminary data in human papillomavirus (HPV) genotyping and urinary tract infection characterization. The creators of the Nanopath platform envision it as becoming the gold standard in routine women’s health screening at the point of care. Nanopath believes that, by focusing on the unmet needs in the women’s health space, they will be positioned to tackle other diagnostics markets.
Reliable and portable detection of sexually transmitted diseases
Traditionally there have been two main choices for diagnostics when it comes to sexually transmitted infectious diseases: antigen tests, which have lower performance but higher speed, and polymerase chain reaction (PCR) tests, which have high accuracy but lengthy turnaround times. Visby Medical seeks to change this by introducing PCR Point-of-Care Tests. The tests represent the latest in portable PCR technology, which has the potential to change how clinicians fight infectious diseases.
Typically, the PCR process involves large and expensive equipment. However, the new diagnostic platform developed by Visby is an instrument free, all-in-one PCR platform said to provide accurate results within 30 minutes. Because of its portability, samples no longer need to be sent to remote central labs for processing as this sexual health click test is easy to use and has greater than 97 percent accuracy. This means that a patient could receive a data driven diagnosis and treatment during their first visit with a health care provider.
Currently, Visby’s platform has been shown to detect DNA from pathogens that cause chlamydia, gonorrhea, and trichomoniasis. The device’s portable size and stability at room temperature means it has the potential to benefit patients in remote areas and is highly suitable for use with deployed military forces.
Springboards for future innovation
Of the three finalists, Nanopath's solid state biosensing platform took home the 2022 AACC Disruptive Technology award at AACC in July. And in August, the woman-led company announced it had closed $10 million in Series A funding to develop and commercialize its women’s health diagnostic platform to improve the care of this underserved population. “That said, our technology has the potential to be valuable in any situation where DNA or RNA detection is useful, including respiratory disease diagnosis, characterization of genetic risk factors, and even biosecurity surveillance and environmental monitoring,” said Alison Burklund, PhD, co-founder and CTO of Nanopath in an August press release.
Overall, these three finalists showcase both how far we’ve come with regard to diagnostic technology and how far we can still go. There’s no doubt that all three technologies will be springboards for future innovation.