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Aided by COVID-19 Funding, Firms Continued Developing Handheld Diagnostic Instruments in 2022

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NEW YORK – In 2022, instrument makers brought testing closer to patients with a swath of portable, often handheld instruments that promise answers at the bedside, at home, and in challenging environments.

Thank COVID-19 for the uptick in interest in such portable systems. For the past three years, the desperate need for rapid test results during the pandemic hastened the transition toward bringing disease testing closer to patients. Federal funding for COVID-19 testing, particularly from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) program, continues to bolster development of instruments for use outside of the laboratory. As a result, many firms pursued COVID-19 testing as the initial applications for their technology.

In September, RADx opened applications for up to $300 million in funding for COVID-19 tests for use at home by people with disabilities and OTC or point-of-care COVID-19 tests with improved performance that minimizes the need for serial testing. The new funding is for a wide range of novel technologies that may have been skipped over by prior RADx funding, including handheld PCR devices.

But firms in the portable testing space are looking beyond COVID-19 and the inevitable wind-down of the US Food and Drug Administration's Emergency Use Authorization issuances for COVID-19 tests and potential reduction in future demand for the tests. Each instrument sold is a foothold that gives the firm a chance to prove its worth, build a customer base, and diversify their testing lineups.

For infectious disease tests, many of the technologies offer not only portability but also a third option that balances the advantages of high-speed, low-cost antigen tests and high-sensitivity PCR tests.

Many of the instruments coming onto the market incorporate RT-LAMP or RT-qPCR methods whereas others use technologies such as electrochemical analyzers, Raman spectroscopy, or electrical biosensors, all in hopes of providing laboratory-quality results in compact, lightweight devices.

Pandemic funding opened doors

Among the firms testing the waters beyond COVID-19, Visby Medical said in March it secured a $25.5 million contract option with the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response to develop an at-home version of its single-use handheld PCR-based test for influenza and COVID-19. The firm has said both versions of the test deliver results from a single sample in less than 30 minutes. The firm also sells a single-use multiplex PCR test for chlamydia, gonorrhea, and trichomonas with the same turnaround time.

University of Washington spinout Anavasi Diagnostics also received $14.9 million from RADx in 2021, and in 2022, the firm ramped up production of its handheld Ascencio point-of-care real-time loop-mediated isothermal amplification (RT-LAMP) instrument and applied for Emergency Use Authorization for its COVID-19 test. The point-of-care instrument, which weighs less than 1 pound, delivers a positive result via a fluorescent readout within 25 minutes. In early 2022, Anavasi Chief Medical Officer Michael Blaivas said the company has plans for future tests on the Ascencio system with influenza, respiratory syncytial virus, strep A, and sexually transmitted infections. The device is expected to cost about $300 with the capability to perform a minimum of 3,000 tests in its lifetime, with tests priced at $30-$40 each.

Researchers at Pennsylvania State University are similarly developing an all-in-one microfluidic cassette and handheld analyzer using RT-LAMP technology, with an initial application of saliva-based preliminary COVID-19 screening and potential use in detecting other saliva-borne diseases such as influenza or herpes.

Meanwhile, Aptitude Medical went in a different direction for its over-the-counter molecular test, nabbing an EUA for its cartridge-based Metrix COVID-19 Test that uses saliva samples in an isothermal amplification (RT-LAMP) assay that can be run in a clinic or home on a phone-size reader. The California-based firm intends to offer molecular testing for lower cost than lab-based assays. CEO Scott Ferguson said this fall the company had multiplexed tests for COVID-19 and influenza hot on the heels of its COVID-19-only test, an expanded respiratory panel with RSV in the works, and other diseases in the pipeline that he was not ready to discuss.

Midge Medical, meantime, has plans beyond its handheld point-of-care molecular system and COVID-19 test, which received CE marking in May. The firm said last year it planned to launch its Minoo reverse-transcriptase recombinase polymerase amplification (RT-RPA) system in Germany in the fourth quarter of 2022, and it expects to develop additional point-of-care molecular rapid tests.

Beyond respiratory disease

Emeryville, California-based Nanomix is also develop a portable testing system, promising laboratory-quality results in a helicopter, an ambulance, or a crowded emergency room. The company promises rapid infection testing through its eLab immunoassay and chemistry diagnostic instrument and S1 critical infection testing panel, which together detect and measure procalcitonin, lactate, and C-reactive protein levels in 12 minutes. The system uses an electrochemical sensor to run enzymatic assays and immunoassays, and it incorporates a pneumatic system with cartridge-based microfluidics to maintain sample control.

Nanomix secured a series of agreements in 2022 toward commercialization of the eLab and S1 panel, including distribution agreements in the UK, France, Germany, Ireland, Israel, Italy, the Middle East, and South Africa and a collaboration toward a point-of-care COVID-19 antibody test for use in mobile labs in the US. The firm also secured CE marking in May for its COVID-19 antigen test.

Another entrant to the portable infection identification space, Dutch startup Nostics, is developing its portable Raman spectrometry-based Colony-ID miniature bacteria lab with plans to enter the US market in late 2023 or early 2024 and an eye on future expansion to low- and middle-income countries where the company can help deliver rapid identification of bacterial infections at a low cost per test. The firm initially has tests for urinary tract infections and sexually transmitted infections in plated culture and said it plans to develop tests for sepsis from a positive blood culture, UTIs directly from urine samples, STIs from urine, and bacterial meningitis from cerebrospinal fluid.

Meanwhile, Swiss startup Momm Diagnostics is moving forward with its point-of-care test for preeclampsia using its handheld electrical biosensor-based instrument to analyze blood samples on test cartridges. Company officials are seeking investors, conducting performance studies, and planning for further pilot testing of an alpha prototype, all in hopes of making the device available in Europe by the end of 2024.

Menlo Park, California-based Anitoa Systems has taken a different path by focusing on neglected tropical diseases in low-resource areas. In May, the firm unveiled its multiplex test for dengue virus on its Maverick portable RT-qPCR instruments and, in June, the firm said it received CE marking for the monkeypox test it had started deploying in selected clinics in Africa.

The battery-powered device, which is CE marked and is listed as a Class II 510(k)-exempt medical device by the FDA, uses complementary metal-oxide-semiconductor (CMOS) biosensor technology for fluorescence and chemiluminescence molecular imaging.

And London-based Virax Biolabs is closing in on commercialization of its blood-based Virax Immune T-cell test, which could help people identify their immune defenses to SARS-CoV-2 using a handheld device, possibly with microfluidics cartridges. The firm's initial test uses samples treated with a novel peptide mix, incubated overnight, and analyzed using intracellular staining and flow cytometry to measure markers for T-cell activation. Company officials plan to create a suite of tests for other viruses in the next year.

Aside from industry, academic-based researchers also have been developing portable diagnostic devices, whether to improve on existing tech or carve out their own niche.

A group at Johns Hopkins University, for example, is combining surface-enhanced Raman spectroscopy, nanotechnology, and machine learning for a handheld platform with initial uses to detect and distinguish viral infections. The group said early last year it was working on commercialization of a 15-minute saliva-based SARS-CoV-2 test that could be used at sites such as airports, schools, and hospitals, and the group was developing its platform to simultaneously detect and differentiate other viruses.

Future tests could also combine miniaturized robotics and microfluidics. University of California, Los Angeles researchers said this fall they had created a handheld system that minimizes reagent volumes and automates testing using magnetic nanoparticles and mobile magnets to move liquids on a circuit board. A SARS-CoV-2 test that uses the technology for a loop-mediated isothermal amplification test takes about 30 minutes, and the researchers said the technology can perform multiplexed tests and tests using pooled samples.

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