As Worries Grow Over Novel Coronavirus, Dx Industry Jumps Into Action

This story has been updated to include additional developers.

NEW YORK – Quick and accurate diagnosis of infectious disease is a critical tool to manage outbreaks. As the number of people infected with the novel coronavirus, 2019-nCoV, grows and the death toll multiplies, many labs and commercial entities have ramped up their work developing diagnostic tests, while others have jumped into the fray by providing test reagents.

Exactly how companies are validating new tests and reagents is unclear, as is whether they can be used by labs in the US now that a federal emergency has been declared and the emergency use authorization process is presumably open. Nevertheless, the stock prices of several firms who have trumpeted their involvement in 2019-nCoV test development have skyrocketed recently.

For example, after announcing 2019-nCoV test development, Co-Diagnostics saw an 80 percent jump in stock price on the Nasdaq, while Novacyt's stock on France: Euronext Paris reportedly rose 32 percent. And, an announcement from Meridian Bioscience of test reagent availability preceded a 21 percent increase in its stock on the Nasdaq.

How the opening of the EUA pathway could potentially affect labs' ability to use lab-developed tests is also an open question recently raised on social media by former US Food and Drug Administration Commissioner Scott Gottlieb.

In past outbreaks, labs have used commercial tests as LDTs, for example, during the Zika outbreak. That has invoked the ire of FDA in at least once instance. Although there seems to be a growing public demand to ensure testing is widely available, the CDC is also affirming that there is low risk in the US at this time. Presumably low test volumes should be manageable by regional and local public health labs running CDC's test once it is granted EUA as expected, likely later this week.

Patients with suspected 2019-nCoV infection in China appear to have been tested primarily using a real-time fluorescent RT-PCR kit from BGI which recently received emergency authorization from China's National Medical Products Administration. BGI has donated 20,000 kits to support the response to the 2019-nCoV outbreak in Wuhan, China and Hubei Province, where the outbreak originated, and provided about 50,000 test kits in total to hospitals and disease control centers in China.

BGI has since begun a collaboration with Curetis and its subsidiary Ares Genetics to develop a sequencing-based test and to distribute BGI's PCR-based test in Europe. Other firms developing methods to detect or diagnose the coronavirus include Oxford Nanopore, a team of European virologists who pioneered the test protocol guided for use by the World Health Organization, and Co-Diagnostics, as previously reported. Atila Biosystems is also reportedly working to develop a test using its high-throughput isothermal nucleic acid amplification system.

Below are the players who have disclosed, to date, they are developing molecular diagnostic tests and reagents for 2019-nCoV:

• Amoy Diagnostics (Xiamen, China) — developed a PCR-based test kit and has entered the NMPA emergency approval channel.
• Altona Diagnostics (Hamburg, Germany) — developing a real-time RT-PCR based assay for the qualitative detection of 2019-nCoV RNA in respiratory samples.
• Biomeme (Philadelphia) — tests called 2019-nCoV Go-Strips that run on Biomeme's mobile handheld qPCR devices are available on the firm's website. The test contains coronavirus RNA target multiplexed with Biomeme's RNA extraction and RT-PCR control (MS2), with each order containing 10 individually packaged Go-Strips that are shelf-stable for up to two years.
• Bioneer (Daejeon, Korea) — submitted a diagnostic test kit for emergency use assessment and listing (EUAL) to the Korea Centers for Disease Control and Prevention (KCDC).
• CerTest (Zaragoza, Spain) — developing a test kit called VIASURE 2019-nCoV Real Time PCR Kit, based on its existing qPCR tests for other coronaviruses.
• Center for Convergent Research of Emerging Virus Infection (CEVI) at the Korea Research Institute of Chemical Technology and Wells Bio (Seoul, Korea) — pursuing joint development and commercialization of molecular and immunological diagnostics to detect a 2019-nCoV gene and a viral antigen.
• Columbia University (New York City) — the lab of Ian Lipkin is reportedly developing a test to detect and differentiate 2019-nCov from influenza.
• Coyote Bioscience (Beijing) — has reportedly submitted its one-hour, sample-to-answer 2019-nCoV Prep Free QPCR Assay to NMPA for emergency authorization. It runs on the firm's CFDA-approved Mini8 Portable Molecular Diagnostic QPCR Station. The test is reportedly being used as an RUO in China in more than 30 hospitals, 16 local CDC offices, and eight airports, and the firm has donated 500 instruments to Hubei province.
• GeneFirst (Oxford, UK) — developing two test kits; a three-hour PCR-based test for 2019-nCoV, and a multiplex PCR assay for 2019-nCoV as well as 17 other common viruses and bacteria.
• Genekam Biotechnology (Duisburg, Germany) — developed singleplex and multiplex test kits to detect 2019-nCoV as well as to distinguish it from other infections, such as influenza, MERS, and viruses commonly found in bats.
• Genomica (Madrid) — developing a 2019-nCoV diagnostic kit to simultaneously analyze 96 patient samples in less than five hours, to be available in five to seven weeks, using the firm's low-density microarray-based platform. Genomica has also had a subsidiary in Wuhan, China, named HuaSin Science, since January 2018.
• GenScript (Piscataway, New Jersey) — has launched a one-step 2019-nCoV quantitative reverse-transcription polymerase chain reaction (RT-qPCR) based on the World Health Organization's protocol. The firm is also marketing plasmids encoding the surface glycoprotein and nucleocapsid phosphoprotein of 2019-nCoV that can be used as positive control for the detection of 2019-nCoV by RT-PCR.
• IDbyDNA (Salt Lake City, Utah) — the firm's Explify Respiratory test uses next-generation sequencing-based metagenomics to detect 2019-nCoV as well as over 900 other viral, bacterial, fungal, and parasitic pathogens. It is a validated LDT currently offered by IDbyDNA's Salt Lake City lab for respiratory pathogens, including human coronaviruses, and its 2019-nCoV detection has been computationally validated using in silico generated samples.
• Kogene Biotech (Seoul, Korea) — submitted a diagnostic test kit to the KCDC for EUAL.
• LabGenomics (Seoul, Korea) — developing a kit and anticipates commercialization in the next two months.
• Lexagene (Beverly, Massachusetts) — developing a test for its one-hour, open-access LX Analyzer system.
• Novacyt (Paris and Camberley, UK) — the firm's molecular diagnostics division, Primerdesign, has launched a two-hour molecular test, available as an RUO test, designed to run on multiple molecular testing platforms, including Primerdesign's genesig q16 and q32 instruments.
• PCL (Seoul, Korea) — in the process of commercializing its multiplex diagnostic kit.
• Roche Diagnostics (Basel, Switzerland) — the firm has partnered with Tib-Molbiol to launch three research-use-only assays for the LightCycler 480 high-throughput real-time PCR instrument, as previously reported.
• Thermo Fisher Scientific (Waltham, Massachusetts) — has developed a real-time PCR kit for the detection of RNA from 2019-nCoV, using Applied Biosystems TaqMan Assay technology, which is now available to order. The firm is also developing a multiplexing test that offers a faster time-to-result to further expand laboratory capacity, which will be available within the next few weeks, as well as a syndromic panel it expects to be available in late February.
• TCM Biosciences (Seoul, Korea) — developing a test called TCM-Q Corona III.
• University of Hong Kong (Hong Kong) — researchers have developed two single-step quantitative real-time reverse-transcription PCR assays to detect two different regions of the viral genome, as described in a recent Clinical Chemistry study.

Firms with nCoV-related reagents

• Integrated DNA Technologies (Coralville, Iowa) — the firm is now accepting pre-orders for qPCR primers and probes designed to detect 2019-nCoV from the global health and research communities, with shipment to begin next week.
• LGC (Milford, Massachusetts) — the firm's SeraCare Life Sciences subsidiary has developed molecular reference materials for coronavirus utilizing their proprietary AccuPlex recombinant technology. The AccuPlex reference materials mimic wild-type pathogenic viruses, but are safe, non-infectious, and replication-deficient. LGC's Biosearch Technologies subsidiary is also expediting availability of its as Black Hole and Blackberry Quenchers (BHQ and BBQ) and other dyes and components used in diagnostic kits, as these are explicitly mentioned in the publication describing the primer and probe sequences recommended for 2019-nCoV diagnosis.
• Longhorn Vaccines and Diagnostics (Bethesda, Maryland) — the firm has announced its PrimeStore MTM collection medium is the first and only device that is validated for coronavirus and that the FDA created a new category for it: FDA Cleared: New Class II Predicate Device Oral and Nasopharyngeal swab screening. Samples collected into PrimeStore MTM may provide early detection of coronavirus carriers and spreaders prior to symptoms such as fever, and they can be tested in any molecular lab, not just containment facilities.
• Meridian Bioscience (Cincinnati, Ohio) — the firm's freeze-dried Lyo-Ready 1-Step RT q-PCR mix is reportedly being used in the coronavirus outbreak in China.
• Thermo Fisher Scientific (Waltham, Massachusetts) — the firm supplies various master mixes and polymerases for diagnostic testing that have been cited in several publicly available 2019-nCoV real-time PCR protocols.