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With its Handheld Lab, Nostics Aims for Faster, Cheaper Point-of-Care Bacterial Pathogen Testing


NEW YORK – Promising the world's smallest bacteria lab and results within minutes, Dutch startup Nostics aspires to expand point-of-care testing for bacterial pathogens, starting in the US.

"We're definitely focused on low-resource settings, decentralized testing, and really increasing the testing capacity of our healthcare system," said Nostics Chief Operating Officer Eva Rennen.

The firm is working with the US Food and Drug Administration to evaluate regulatory paths for its Mini-Lab instrument – soon to be renamed Colony-ID – ahead of a planned launch in the US market by late 2023 or early 2024, Rennen said. It also plans to secure certification in the EU under the In Vitro Diagnostic Regulation that took effect in May.

"We are now setting up our US strategy and, in parallel to it, we'll be going forward to the EU market," she said. "Our mission is to provide accessible diagnostics, so, when we've gone through FDA approvals, we'll be able to [look] at low- and middle-income countries to see how we'll be able to make an impact."

The spectroscopy instrument's initial applications will focus on helping laboratories identify the bacterial causes of urinary tract infections and sexually transmitted infections in plated culture. The next tests in its pipeline would identify sepsis from a positive blood culture and UTIs directly from urine samples, Rennen said, and further testing will show whether the device can identify bacteria directly from other patient samples to help diagnose STIs from urine and bacterial meningitis from cerebrospinal fluid, for example.

"For each and every one of these applications, obviously, we need a R&D cycle to make sure it actually works every single time," she said.

Nostics is designing the instrument and cloud-based analysis to deliver results within 15 minutes at a cost of about €15 ($16) per test, although that price could vary by region and local reimbursement guidelines, according to information provided by the company.

Rennen said the company is developing a version of the same portable Raman spectrometers used within the pharmaceutical industry to verify the contents of pills and tablets and by security agencies to screen for explosives or narcotics.

"There are a number of manufacturers of these devices, but they've never used it for medical diagnostics," she said.

Raman spectroscopy entails shining a light on a sample, where molecules vibrate as they absorb some of the light and reflect light back in a scattered pattern. The reader picks up the wavelengths and intensity of that reflected light.

Biological materials are typically difficult to identify with Raman spectroscopy, Rennen said, so the company added a disposable cartridge that is embedded with a metal nanostructure layer on a silicon base to enhance the signal emitted when the laser light hits the liquid sample. Nostics' device identifies its targets indirectly by targeting the metabolites they excrete in water.

Rennen said the price of such instruments ranges from $5,000 to $40,000. While she said that price per test is lower than with mass spectrometry, for example, Nostics is working to further bring down that instrument cost. The company is also considering subscription-based agreements that would let point-of-care healthcare providers use the devices without buying them.

By identifying the causes of infections, the instrument can help doctors personalize therapies, reduce unnecessary antimicrobial prescribing, and reduce selection pressure for drug resistance.

"Antimicrobial resistance, just like COVID, it's a global issue so our market is global," she said. "However, we're starting in the US. It's a massive market."

To reach that market, Nostics has been looking for and establishing collaborations with US distributors, as well as seeking out experts on the need for such a device in US markets. The firm has raised about $7.5 million so far through venture capital investments and Dutch and European government funds and is trying to grab the attention of US investors for an ongoing Series A financing round.

In addition to the speed, portability, and lower cost per test, Rennen said the instrument's automated cloud-based interpretation of spectroscopy data reduces the risk of human error, and its digital output makes patient results available to surveillance systems, laboratories, and hospitals.

The instrument developed out of molecule detection work done by Nostics cofounders Rennen, Vincent Laban, Johan Verwey, and Rochelle Niemeijer at VSParticle, a nanotechnology spinout from Delft University of Technology in the Netherlands. The idea to use the technology in medical diagnostics formed, in part, from a colleague's sales trip to Japan in early 2020, when the country was dealing with the spread of COVID-19 aboard a harbored cruise ship and preparing for the Summer Olympic Games.

"We quit our jobs, and we decided to go for it right in the middle of a lockdown," Rennen said. "So, it was an exciting time, to be honest, but we felt like we had to do it."

The firm has already commercialized a separate COVID-19 antigen test, a three-minute point-of-care lateral flow assay that is read by the firm's CE-IVD marked immunofluorescence antibody assay instrument, Virus-ID. Rennen also acknowledged that many more point-of-care PCR assays have come to market since the start of the pandemic, which has been great for bringing testing closer to patients.

Nostics has focused on developing a testing system that can be used in remote locations, needs little electricity, and can be run with limited training so the company can bring testing closer to patients and prescribers.

Another company in the portable point-of-care testing market, Nanomix, has been striking commercialization deals for its eLab electrochemical analyzer, a handheld instrument that has solid-state sensors and a pneumatic sample control system so it can be used even in challenging environments such as ambulances, helicopters, and crowded emergency rooms. Like Nostics, Nanomix is competing in the sepsis and critical infection market with its S1 infection panel.

Nanomix CEO Thomas Schlumpberger said point-of-care companies have the challenge of delivering the accuracy of a laboratory but also the opportunity to help deliver more ambulatory or at-home care that could reduce unnecessary trips to emergency rooms, lower healthcare costs, and allow recovery at home for more conditions.

"As a point-of-care platform or as a point-of-care product, you have to be as accurate in terms of sensitivity and specificity as the central lab," Schlumpberger said. "Otherwise, the doctor will not look at you."

Rennen said Nostics does not yet have any published data but its internal study results show the test works, and the company is working with FDA officials to determine how to validate its findings. The internal results suggest the device can distinguish between even genetically similar bacteria such as Shigella, Escherichia coli, and Shiga toxin-producing E. coli, she said.