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Diagnostics Firms Rush to Develop Rapid Point-of-Care Tests for Novel Coronavirus

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NEW YORK – Rapid near-patient and point-of-care testing could help more efficiently triage suspected cases of novel coronavirus, helping to focus limited resources on enabling appropriate use of quarantine. A handful of diagnostics developers are now striving to bring rapid 2019-nCoV tests to market as soon as possible, with hopes of ultimately assisting with the growing number of cases in China.

Molecular diagnostic tests for use at the point of care are in development from Cepheid, HiberGene, Mobidiag, and QuantuMDx, as is a rapid immunoassay from a manufacturer in Canada, Sona Nanotechnology. A point of care test from Coyote Bioscience is currently in use in China, and OnSiteGene and MolBio are also working on point-of-care tests as well.

Lab-based tests — such as the rRT-PCR test kits and syndromic panels being developed for 2019-nCoV — typically require expert technicians and take a few days to turn around results. Rapid tests, meanwhile, are often less complex and typically take less than one hour.

Cepheid may have some advantages in the point-of-care molecular testing space because it already has instruments placed in China. Mobidiag, meanwhile, may offer additional benefits with a multiplex test for coronavirus and influenza, while HiberGene may get closer to patients and possibly be available the soonest.

Cepheid is early in the design and development phase of an RT-PCR test for 2019-nCoV, according to David Persing, the firm's chief medical and science officer. The company expects to have a prototype assay in six to eight weeks and be ready to pursue Emergency Use Authorization in the US in approximately 90 days.

The 30-minute test will leverage Cepheid's existing flu A/B and RSV test, Persing said, using the same sample preparation, swab type, and many of the same reagents. It will also target multiple regions of the virus as well as a conserved coronavirus sequence, in order to control for potential genetic drift.

Given the firm's footprint of 23,000 GeneXpert instruments, as well as an installed base in China of 2,000 systems, Persing said developing a rapid test was the right thing to do.

"This is not going to be a financial goldmine for Cepheid. This is something we feel obligated to do because of our global footprint, and the fact that there is laboratory capacity already in place and it doesn't require much training to run a new GeneXpert test," Persing said.

Cepheid previously developed an assay for the Ebola virus that received EUA in 2015 and is being used in the current Ebola outbreak in the Democratic Republic of the Congo. "It is available and validated, it works well, it is best in class for Ebola nucleic acid detection as shown in multiple studies, and it is decentralized to the point-of-care," Persing said. "That's what they need to be able to make triage decisions in real time – they need a technology that doesn't require central lab testing that takes a week or longer," he added.

For 2019-nCoV, a decentralized POC option is also "badly needed," he said, particularly considering that there are reports of atypical presentations of infection that may be going undetected while suspected cases who are actually infected with something else must be quarantined until test results come back negative.

"It is very challenging to implement isolation and quarantine if you don't know who is infected," Persing emphasized.

The GeneXpert tests will be manufactured either in the US or at Cepheid's facility in Stockholm, Sweden. Persing said that Cepheid, a Danaher subsidiary, also has scalability of production that could help make tests available rapidly.

Cepheid is funding the project internally at this point, but has spoken with numerous organizations about potential funding, Persing said, including the Biomedical Advanced Research and Development Authority, or BARDA, an agency that recently began soliciting applications for 2019-nCoV tests.

Dublin, Ireland-based HiberGene, meanwhile, is also developing a rapid point-of-care test for 2019-nCoV. Simona Esposito, HiberGene's CEO, said in an interview that the firm has expedited the development of a test. She expects it to be validated soon, and to have prototypes for patient testing in China ready to ship in three to four weeks.

HiberGene has a pre-existing partnership with a distributor in Shenzhen, China, called Medcaptain Medical Technologies and will leverage that relationship to pursue Fast Track Emergency Use with the National Medical Products Administration.

HiberGene recently successfully completed three clinical trials in China to support NMPA clearance of an assay for Group B Strep, Esposito said. The firm had planned to launch its system there with the GBS test, but may now accelerate plans with a 2019-nCoV test if it is cleared in China.

The firm's assay system is small, portable, battery-operated, and low cost. It runs loop-mediated isothermal nucleic acid amplification (LAMP) testing. Esposito said that HiberGene does not yet have instruments installed in China, but as demand increases in testing venues with more limited resources, the firm could be ready to supply its platform and tests to places like smaller clinics and pharmacies.

The company has developed 10 assays that are cleared in Europe, including a few multiplexed LAMP tests, in the past four years. "One of our core competencies is speedy development and design of molecular diagnostic tests," Esposito said.

That full menu could also potentially be available to customers in China moving forward, Esposito said, once the tests are cleared by NMPA. The one-hour tests require personnel to have some training, but not be highly trained experts, and because the tests are extraction-free, they can utilize crude samples in limited-resource settings.

She further noted that the firm is already selling systems in other countries in Asia, such as Taiwan and Thailand, and also in Australia and Eastern Europe. The company will now consider responding to initiatives in China and Europe, including a call from Horizon 2020, for funding to help accelerate rollout, but for the time being HiberGene is ramping up test development with its own funding.

The same holds true for Mobidiag, the Espoo, Finland-based firm also developing a 2019-nCoV rapid point-of-care test. Tuomas Tenkanen, CEO of Mobidiag said the firm's test will run on the its Novodiag instrument, which is a sample-to-answer cartridge-based qPCR system with accelerated turnaround time enabled by rapid thermal cycling.

A major differentiating factor of the Mobidiag test is that it will detect and distinguish 2019-nCoV, influenza A, and influenza B viruses. Tenkanen expects the test to be ready for clinical evaluation within a month, and the firm will pursue regulatory paths appropriate to different geographies.

In 2019, Mobidiag established a joint venture in China in collaboration with Autobio, a market-leading clinical diagnostics company in the country, called Automobi Molecular Diagnostics. The firm does not have any instruments yet installed in China but is evaluating several tests for the market there.

Mobidiag is also looking at possible funding opportunities, "But for us the most important thing is to develop it rapidly," Tenkanen said.

The Novodiag is a closed system, which Tenkanen emphasized is important for infectious diseases like 2019-nCoV. And, the system can also be used to for other testing, including multiplexed tests. Mobidiag makes a highly multiplexed test in Europe to detect 26 parasites, Tenkanen said, and its carbapenemase-resistance test can also detect multiple targets.

Executives from both Cepheid and Mobidiag noted in interviews that they are working on highly multiplexed respiratory panels, as well.

QuantuMDx, a Newcastle, UK-based developer of a handheld molecular diagnostic system called Q-POC, is also developing an assay for 2019-nCoV, according to the firm's CEO Jonathan O'Halloran.

"Rather than pushing tests into laboratories, we are working to create a platform to allow health workers to run the tests where it matters, at the patient's side and while the patient waits," O'Halloran said in an email.

And, Beijing-based Coyote Bioscience also has submitted its one-hour, sample-to-answer 2019-nCoV Prep Free QPCR Assay to NMPA for emergency authorization. The test runs on the firm's CFDA-approved Mini8 Portable Molecular Diagnostic QPCR Station.

According to Sabrina Li, the firm's founder and CEO, the 2019-nCoV test is currently being used as an RUO in China in more than 30 hospitals, 16 local CDC offices, and eight airports, and the firm has also donated 500 instruments to Hubei province. Coyote previously developed a test for the Zika virus that was deployed as a screening assay in airports in China.

MolBio Diagnostics of Goa, India is also developing a 2019-nCoV test for its small, portable system, called the TrueLab. The system consists of two instruments and two consumables. Its TruePrep instrument prepares the sample with a 20-minute sample prep step, and its TrueNAT instrument then performs 40-cycle real-time PCR in 35 minutes, and can detect three wavelengths of fluorescent signal. The firm has been pioneering point-of-care tuberculosis testing in collaboration with FIND, and it also manufactures a variety of other infectious disease assays.

MolBio's marketing manager Sumit Mitra confirmed in an email that the company is working on an assay using sequences from the World Health Organization. "We expect clinical trials with our National Institute of Virology sometime soon," Mitra said.

OnSiteGene, a San Diego-based subsidiary of Singapore's Star Array, has also developed a rapid point-of-care qPCR-based system, called the Peak V, that performs spatial thermal cycling using a heated liquid metal, as previously reported. Each of the 32 reactors in the Peak V can also support a multiplex test with up to four targets.

Liwei Qi, OnSiteGene's chief technology officer, said in an email that the company has developed a 2019-nCoV rRT-PCR kit that can perform direct amplification on its instrument, and can analyze 16 to 32 samples in a few minutes, without the need for sample prep.

"Both the instrument and the 2019-nCoV detection kit are ready for clinical testing, and we are currently seeking collaborators to perform tests in China and the US," Qi said.

OnSiteGene is also developing a fully-automated system integrating five-minute qPCR with a superfast sample prep module, Qi said, and that system will be able to detect pathogen and report results in sample-in-answer-out fashion in less than 10 minutes.

Finally, although rapid molecular diagnostics are considered to have superior sensitivity and specificity, rapid, non-molecular tests might also be a huge advantage for screening. To date, there is one firm that has publicly described working on such a test.

Darren Rowles, CEO of Sona Nanotech, said in an interview that the firm will leverage its gold nanorod particle technology to create a lateral flow 2019-nCoV test for screening.

The Halifax, Nova Scotia-based firm has been a supplier of its reagents to other test developers since its founding, so the 2019-nCoV test would likely be its first diagnostic, although it is has also been working on a few other diagnostic tests recently. It has now locked down access to the materials required from its supply chain to expedite test development and distribution, Rowles said.

Sona has also used protein expression to develop antigens that will be used in its lateral flow immunoassay test. The firm expects its test will cost less that $50 and take between five and 10 minutes to run.

Even without excellent sensitivity and specificity, immunoassay tests could still be useful for screening and triaging symptomatic patients in outbreak situations. But Rowles noted that Sona's nanorod technology yields higher sensitivity and specificity than is typically seen in lateral flow tests. Historically, in the case of Ebola one immunoassay was also shown to have excellent performance, superior to a RT-PCR test.

Sona is in discussion with FDA, Rowles said, and plans to talk to groups in China too, as well as larger commercial groups. It will be expediting test development, but Rowles was unable to specify a timeline at this time.

Helping combat the epidemic more effectively is critical, though. "This is why, as a bunch of scientists, we got into this — to be able to use our technology and deploy it for humanitarian benefit," Rowles said.

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