The landscape of COVID-19 testing has been rapidly evolving.  New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods.  With the sudden global demand and governments loosening requirements during the crisis, there has been an unprecedented flood of products.  It has attracted scores of companies, some of which have rushed or cut corners and produced tests with low accuracy.  In many cases there have been recalls and the FDA has issued warning letters, revoked EUAs, and tightened some of its more lenient regulations, for example for Policy D antibody tests.

Along with labs procuring additional systems and increasing their staffing, there are other ongoing activities that are being undertaken to address the various challenges of COVID-19 testing.  The growth is expected to continue, even with some areas seeing declining cases for example in the US.  Most labs are using multiple suppliers’ COVID tests, as a way to hedge against shortages or other problems.

A significant but decreasing portion of countries still remains relatively unscathed with small numbers of cases.  There are only about 40 countries with zero to one case per day, out of 210, mainly islands or less-travelled areas.  Regions that are seeing their first spike in cases are now facing the issue of scaling up to the necessary volume.  Due to the unknowns that remain about the virus, it is also still a challenge to determine the appropriate level of testing.  Some lessons can be applied from the countries that were hit earlier

This is partly dictated by the existing instrumentation but there is usually some flexibility.  Pooling and other techniques are being incorporated to stretch supplies out for more tests.

Due to the supply situation as well as the nature of scientific collaboration, many professional organizations have taken the initiative to address the challenges.  The Association for Molecular Pathology (AMP), for example, has developed five key recommendations for testing labs to best respond to the pandemic, based on its recent survey –

  • Reassess type and location of SARS-CoV-2 testing services needed – better match to the situation
  • Reprioritize supply allocations based on clinical testing needs, which could change over time – e.g. as prevalence falls or climbs
  • Increase transparency, communication, and real-time transmission of information between laboratories and suppliers (commercial manufacturers and government) – reagent, supply, resource availability and supply quantities, allocation strategies etc
  • Real-time coordination amongst laboratories to leverage moments of excess capacity – share supplies to ensure rapid processing of samples
  • Standardize agency reporting format and processes for reportable infectious diseases during a pandemic – reduce significant burden on labs, reduce delays, establish electronic systems and formats.


For countries that are still at the beginning of the crisis, taking these steps could improve the chances of success; and for the others, they will likely be among the key considerations to prepare for the next pandemic.

Companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. The COVID-19 pandemic has gripped the world and continues to be a major area of research and development for diagnostic test developers.

Several approaches continue to evolve, including the use of personalized medicine technologies being adjusted to address the COVID-19 need.

Spartan Bioscience developed its CE and FDA approved DNA analyzer to detect risk of poor treatment choices for patients taking various antiplatelets, antidepressants and PPIs.  People carrying CYP2C19 mutations can impair drug metabolism and alter response to drug therapy.  Over the first-half of 2020, Spartan Bioscience has shifted its technology to focus on detecting COVID-19 and Legionella using its qPCR on-site DNA analyzer.

Our report on companion diagnostics (https://kaloramainformation.com/product/companion-diagnostics-in-the-covid-19-era/), and found that COVID-19 has had a small impact on the market for important cancer test and drug combinations.  But since the oncology therapeutics these tests help facilitate are critically important for patients, that impact was limited.  This was according to informal surveys of companion diagnostic vendors conducted by the authoring analysts of the market report.

Along with new developments, diagnostic service providers are also shifting workloads to address the demand for COVID-19 services.  MiraDx, for example, has opened its CLIA-certified lab to providing COVID-19 test services.  The lab has an analyze capacity of over 9,000 tests with no backlog, reported by MiraDx.  The company also reports test results are available in approximately 48 hours and are being prioritized for hospitals, essential workers and field-based healthcare workers.  MiraDx lists the test at $150 per completed test.
Minimal Ongoing Disruptions

Analysts contacted some oncology treatment centers and others focusing on CDx activity  to determine the impact of COVID-19 on laboratory activity.  The analysts of the report found.

• Initial (March 2020) decline in CDx requisitions, yet by April 2020 this was largely resolved;
• Less than 10 percent reduction in test volume reported;
• Budgets largely frozen, no capital expenditures will be initiated in the foreseeable future;
• Some backlog on processing tests due to restructuring of hours and laboratory layout requirements; and
• By appointment only lab draws were in effect beginning around February 2020 for some facilities and ongoing through April 2020 which impacted test volume slightly.

Delaying treatment in patients with overall good prognosis would be detrimental to the outcome in some patients prescribed targeted therapies, primarily cancer therapies.  Therefore, oncologists report only minimal delays in treatment which is often determined case-by-case, dependent on factors such as disease status, cancer type, age of the patients, etc.

For example, systemic therapy may be delayed for a short period in patients aged 50 or older with non-aggressive tumor types; in contrast, delaying treatment in an aggressive tumor could be catastrophic to the patient’s outcome.  The National Institutes of Health (NIH) lists more than 200 clinical trials currently underway for COVID-19 biomarker discovery, development and clinical application.

Along with new developments, diagnostic service providers are also shifting workloads to address the demand for COVID-19 services.  MiraDx, for example, has opened its CLIA-certified lab to providing COVID-19 test services.  The lab has an analyze capacity of over 9,000 tests with no backlog, reported by MiraDx.  The company also reports test results are available in approximately 48 hours and are being prioritized for hospitals, essential workers and field-based healthcare workers.  MiraDx lists the test at $150 per completed test.

There is also a growing trend for treatment centers, specifically cancer treatment centers, and research hospitals to get involved in the COVID-19 recovery plan.  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University (Baltimore, Maryland, United States) is gearing up to commence a Phase II trial to promote recovery from COVID-19 with ivermectin or bicalutamide endocrine therapy.  The study is an interventional trial with an estimated enrollment of 60 participants that have had a confirmed PCR test of COVID-19 infection and require inpatient hospitalization due to COVID-19 with minimal or no respiratory symptoms. Estimated start date is June 2020 with estimated completion in June 2021.

 

In Kalorama information’s Emerging Infections Testing report (https://kaloramainformation.com/product/emerging-infectious-disease-diagnostics-markets-and-trends/) , we discussed Chagas.  Chagas disease is named after the Brazilian physician Carlos Ribeiro Justiniano Chagas, who discovered the disease in 1909. Chagas disease (Trypanosoma cruzi, known as kissing bugs) is also referred to as American trypanosomiasis. It is endemic throughout Mexico, and Central and South America, and is caused by the protozoan parasite T cruzi, which is transmitted to humans by blood-sucking insects of the family Reduviidae (Triatominae).  Now there is word  that the Defense Department is concerned enough to embark on a study, which is just the latest indication of the disease threat in the United States.

Chagas disease is part of the trypanosomal group of diseases that includes human African trypanosomiasis (also known as African sleeping sickness), and leishmaniasis. These diseases are grouped together because they share a common family of vectors: African trypanosomiasis (Sleeping Sickness, caused by Trypanosoma brucei), South American trypanosomiasis (Chagas Disease, caused by Trypanosoma cruzi), and leishmaniasis (a set of trypanosomal diseases caused by various species of Leishmania).

Chagas represents one of the greatest and least publicized public health problems in Latin America. Transmission occurs through insects that spread in low-income rural and peri-urban housing and through uncontrolled blood transfusions.

Although mainly a vector-borne disease, Chagas disease can be acquired by humans through blood transfusions and organ transplantation, congenitally (from a pregnant woman to her baby), and through oral contamination (foodborne).

Chembio, Bioconcept and Altona Diagnostics are among the companies that produce tests for Chagas.   Last year, a study found that a combination of marketed rapid point-of-care (POC) diagnostics was useful in screening for Chagas disease in a study conducted in Bolivia. The results compared well with the gold standard enzyme-linked immunosorbent assay (ELISA) approach, which is a challenge in low-resource settings, researchers reported on December 19 in PLOS Neglected Tropical Diseases.  Molecular testing is the most effective technique, however it is not widely available for screening programs. There is some expectation that current advancements in miniaturization may lead to cost-effective molecular devices. In the meantime major health organizations have been motivated to take action.

Doctors in the United States that treat people with Chagas disease, a parasitic illness transmitted by the “kissing bug” in the Americas, are increasingly worried about the estimated 30,000 to 45,000 people that are at increased risk of complications from COVID-19 because they have Chagas-related heart problems. As an indication of that concern, the U.S. Department of Defense has granted 700,000 to Texas State University to conduct a study assessing the threat of Chagas disease to military bases. https://www.sanmarcosrecord.com/news/texas-state-university-study-chagas-disease-threat-military.

 

The fast spread of COVID-19, a respiratory condition, has healthcare systems focused on other diseases that could spread using the same method.     Kalorama Information’s Emerging Infectious Disease Diagnostics report: (https://kaloramainformation.com/product/emerging-infectious-disease-diagnostics-markets-and-trends/) details multpile types of viruses that are being tracked worldwide, many that have jumped from developing nations to developed ones.  These are some of the known infectious disease threats, and there is the possibility there could be unknown pathogens as well.

Streptococcus pyogenes (group A streptococcus, GAS) colonizes the throat or skin and is responsible for a broad spectrum of diseases that range from simple and uncomplicated pharyngitis and skin infections (impetigo, erysipelas, and cellulitis) to scarlet fever and life-threatening invasive illnesses including pneumonia, bacteremia, necrotizing fasciitis, streptococcal toxic shock syndrome (TSS), and sequelae such as acute rheumatic fever, reactive arthritis and glomerulonephritis.

Chlamydia pneumoniae [unrelated to the sexually transmitted disease] can trigger pulmonary infections.  Prevalence in the general population is high, reaching up to 70%.  Asymptomatic progression of an infection with Chlamydia pneumoniae is often problematic because a primary infection may not be diagnosed until it has led to chronic conditions like asthma or chronic obstructive pulmonary disease.

Acute pharyngitis or Strep throat is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States.

Respiratory syncytial virus (RSV), which causes infection of the lungs and breathing passages, is a major cause of respiratory illness in young children.

“These are some of the known respiratory system-based infectious disease threats, and there is the possibility there could be unknown pathogens as well.”

Bordetella pertussis is the microorganism that causes the whooping cough; a very contagious infectious disease worldwide spread that affects mainly children aged 0 to 4.  Whooping cough was once a terrible menace to children, with hundreds of thousands of cases reported annually.  Then a vaccine drove cases down, and the illness became thought of as rare and even antiquated.  But it never totally disappeared; in 2018 the World Health Organisation reported 151,074 pertussis cases globally.  Based on 2008 data the WHO estimated that there were 89,000 deaths.

Discovered in 2001, human metapneumovirus (HMPV) shares many symptoms with the flu.  Research has shown that HMPV is one of the most common causes of acute respiratory infections.  For otherwise healthy children and adults, it tends to be a minor illness, but can be serious for populations including the very young, the very old and people with underlying health problems, such as asthma or chronic heart disease.

Besides respiratory conditions, diarrheal disease, also known as gastroenteritis (GI), affects approximately 1.7 billion people each year and is a leading cause of child morbidity and mortality worldwide and especially in developing countries. In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations and 17,000 deaths.  Shiga toxin-producing E. coli are commonly associated with food- and water-borne outbreaks of diarrheal illness.  E. coli O157 is the most well-known strain and has been responsible for numerous outbreaks.

These diseases and others are a continued focus of development for in vitro diagnostic manufacturers.

Drug discovery is a high-cost, risky business because only a fraction of the therapeutic targets selected for study will actually yield products that achieve regulatory approval by the U.S. Food & Drug Administration (FDA) or other global regulatory agencies. The average drug can take 10+ years to progress from the discovery phase to the clinic, with only one compound out of 10,000 evolving into a viable product. The increasing demand for outsourcing has spawned a proliferation of companies offering contract drug discovery services. Contractors competing in this sector range from small regional companies with a limited geographic reach to medium and large CROs with a large global footprint. As more pharmaceutical companies from emerging countries become major players in the pharmaceutical industry, and multinational pharmaceutical companies expand into emerging countries, the global demand for drug discovery services will continue to expand, although it will be affected by the 2020 corona virus pandemic, lockdown and expected recession.

According to Kalorama Information’s latest report, the market for outsourced drug discovery services has been robust. This is expected to change dramatically in 2020, with ongoing recovery through the five-year forecast period of this report. The global market is estimated at $31.6 billion in 2019 up 15.8% from $27.3 billion in 2018,

The net impact of the corona virus and lockdown will be to inhibit global drug discovery outsourcing while creating opportunities for the development of corona-related vaccines and therapies.

As of May 2020, economic analysts around the world broadly predict an economic recession resulting from the dramatic slowdown in business activities during the corona virus lockdown. The full impact of the global corona virus contagion is not yet understood. In fact, even as a clearer picture emerges in the coming months, the economic ramifications are unlikely to be fully grasped until 2021 or beyond.

As the lockdown requirements are designed to prevent the spread of the corona virus in large groups of individuals who have direct physical contact with each other, manufacturing operations of many companies have been suspended. The pharmaceutical and biotechnology industries, however, are considered life sustaining and therefore medicines and vaccines continue to be produced. As of early May 2020, no significant shortages have been reported.

This could change, however, if the lockdown requirements become more stringent; while the current trend appears to be easing of lockdown restrictions, a significant subsequent wave of infection could reverse this. Furthermore, the industry remains subject to market forces, economic cycles and consumer demand. Although low cost generic medications will probably maintain their sales levels, branded medicines are likely to suffer.

While only two weeks of the first quarter of 2020 could truly be said to be under the grip of the U.S. portion of the COVID-19 pandemic and associated social distancing, companies with molecular diagnostic divisions reported a variety of positive results.  Kalorama expects further growth in the sector in Q2 reports and some tail off as immunoassay tests replace molecular, per Kalorama’s most recent report – COVID-19 Update: Impact on Molecular Markets…

We expect further growth in the sector in Q2 reports and some tail off as immunoassay tests replace.

  • Abbott Molecular Division (represents the m2000 SARS-CoV-2 Test) up 30%; Rapid Diagnostics (molecular point of care and other tests, including ID NOW test) up 5.7%. Large increase in shipments of m2000 test reported. Quarter reflected only a few days of ID NOW availability.
  • Hologic Molecular Diagnostics revenue increased 13.6%, or 14.2% in constant currency, the division’s highest growth rate since 2012. This included $3.4 million of sales from the Company’s Panther Fusion SARS-CoV-2 assay.
  •  Roche Molecular Diagnostics posted over 20% growth due to COVID-19.  Telling for other parts of the business:  Centralized and point-of-care , decreased 6 percent, its immunodiagnostics business declined 4 percent. Clinical chemistry sales were flat.

Smaller companies benefited from the general trend of positive results for COVID-19 testing increases.

  •  Twist Bioscience reported that revenues were up 42% – The company launched methylation product for next-generation sequencing.
  • T2 Biosystems Q1 Revenues Jump 43 Percent – In the quarter T2 signed a licensing agreement for SARS-CoV-2 assay development and a purchasing agreement with Vizient.
  • GenMark Diagnostics Q1 Revenues Grow 80 Percent -The company’s revenue growth was driven by increasing sales of its ePlex molecular diagnostics analyzer, which now has a SARS-CoV-2 test.

Companies with life science divisions suffered because of research lab closures.  Kalorama covers these trends and more in its report on COVID-19 Impact on Markets.  The report can be found here: https://kaloramainformation.com/product/kalorama-covid-19-update-impact-on-molecular-diagnostics-serology-critical-care-tests-vaccines-and-telehealth-markets/

Cell therapy involves the modification of human cell which are used to replace or repair damaged tissues or cells. Two areas with growing development and commercialization include chimeric antigen receptor (CAR)-T therapies and stem cell therapies.

According to a recent report from Kalorama Information, the global market for cell and gene therapy in 2020 is estimated to reach $3,866 million And most of the market is for the treatment of cancer. Dermatological, Cardiovascular – Blood, Oncology, Ophthalmic, Musculoskeletal and other conditions.

With the COVID-19 crisis, there are some efforts to adapt this promising technology to the treatment and prevention of the disease. There are a number of companies that are responding to the call to develop a therapeutic or vaccine for the coronavirus including:

Vitro Biopharma offers its umbilical cord derived stem cells AlloRx stem cells and has a patent-pending and scalable manufacturing platform to provide stem cell
therapies to COVID-19 patients.

Celularity and Sorrento Therapeutics entered into collaboration for CYNK-001, an allogeneic, off the shelf, placental-derived NK cell therapy. The companies on January 30, 2020, launched a clinical and manufacturing collaboration designed to expand the therapeutic use of Celularity’s CYNK-001 to COVID-19. Sorrento and Celularity agreed to assess CYNK-001 as a potential novel therapy for coronaviruses, specifically SARS-CoV-2

It’s even possible CAR-T, currently used for types of cancer with limited therapeutics, could be used for COVID-19. CAR-T involves using modified versions of the patient’s own cells for treatment. The engineering of specific virus-targeting receptors onto a patient’s own immune cells is now being explored by scientists from Duke-National University of Singapore (Duke-NUS) Medical School (Duke-NUS), as a potential therapy for controlling infectious diseases, including the COVID-19-causing virus, SARS-CoV-2. This therapy that has revolutionized the treatment of patients with cancer has also been used in the treatment of other infectious diseases such as Hepatitis B virus (HBV), as discussed by the School’s researchers in a commentary published in the Journal of Experimental Medicine.

According to the university, this type of immunotherapy requires specialized personnel and equipment, and it needs to be administered indefinitely. This makes it cost-prohibitive for treating most types of viral infections. However, in the case of HBV infections, for example, current anti-viral treatments merely suppress viral replication and cure less than 5% of patients. Treating these patients with a combination of anti-virals and CAR/TCR T cells could be a viable option. The team’s approach using mRNA electroporation to engineer CAR/TCR T cells limits their functional activity to a short period of time, and hence provides enhanced safety features suited for its deployment in patients with

Despite these efforts, the majority of the market currently is and is expected to represent treatments for cancer.  Kalorama’s report breaks down the market by types of cancer including Blood cancers, Prostate cancer, Melanoma, Other cancers. Oncology drugs Kymriah, Provenge, and Yescarta are primarily responsible for generating sales in the segment.

Kalorama Information, the most trusted name in healthcare and clinical diagnostics market research, has put a large database of diagnostic instruments in the U.S. online free of charge to start-ups, commercial entities developing COVID-19 solutions, and hospitals laboratories so they can locate sites that do testing in the US market.   The entire Clinical Masterfile details the manufacturer and model of 39,628 clinical diagnostic instruments at 5,331 U.S. hospitals. Last month we made the COVID-19 instrument part of our Kalorama Clinical Masterfile available for commercial suppliers and local hospitals and labs.  These data will allow national and local hospitals and suppliers to find each other and get the necessary COVID-19 kits, reagents, and controls distributed through national supply chains or local swaps.

View Molecular Equipment Locations by Manufacturer

Now we have updated that list — The list has 2216 instruments from 1,214 institutions that have FDA EUA authorized instruments for COVID-19 Testing as of 4/15 and another 382 instruments at 165 institutions that could perform authorized assays.  Laboratory professions will be able to use the database to find each other and share reagents and kits needed to maintain their labs’ testing volume.

 

 

The FDA approved BioFire FilmArray COVID-19 test, as well as Mesa Biotech’s Accula.  Both can bring a COVID-19 diagnosis to the point of care where testing is most needed.   BioFire’s Film Array has thousands of placements.  Accula is a hand-held test.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations?utm_campaign=2020-03-24%20CDRH%20New&utm_medium=email&utm_source=Eloqua#coronavirus2019

Tests approved with an EUA include:

  • Mesa Biotech Inc. Accula SARS-Cov-2 Test
  • BioFire Defense, LLC BioFire COVID-19 Test
  • Cepheid Xpert Xpress SARS-CoV-2 test
  • GenMark ePlex SARS-CoV-2 Test
  • DiaSorin Molecular LLC Simplexa COVID-19 Direct assay
  • Abbott Molecular Abbott RealTime SARS-CoV-2 assay
  • Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR
  • Quidel Corporation Lyra SARS-CoV-2 Assay
  • Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test
  • Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
  • Hologic, Inc. Panther Fusion SARS-CoV-2
  • Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
  • Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2

 

 

Demand for testing has gone from a healthcare industry topic to a national crusade in weeks with the onset of COVID-19. High-throughput tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. for the detection of SARS-CoV-2, the virus behind the disease. But for true intervention in doctors offices — or even airports, many see so-called “point-of-care” (POC) IVD tests as the ideal solution.  A new report on worldwide point-of-care markets from IVD market researcher Kalorama Information has been released amid the coronavirus outbreak. The report has markets for all kinds of near-patient testing — everything from self testing for glucose to rapid HIV tests to cardiac marker tests. Yet the focus in recent weeks has been on tests for COVID-19. Point-of-care tests are tests designed to be portable enough and fast enough to be useful during an one visit or in a decentralized location within a hospital or clinic.

To break a transmission chain, fast access is needed. These tools offer fast access, rather than waiting on texts or doctor’s office staff for restults. Kalorama publishes a report each year on POC markets and has just released its 2020 version: https://kaloramainformation.com/product/the-worldwide-market-for-point-of-care-poc-diagnostics-7th-edition/.

In terms of actual tests for coronavirus tests, there are no U.S. approvals at the time of writing, but products are in development. Molecular POC (mPOC) tests make the most sense because the threat is a virus and can be identified using the gold standard of reverse transcription polymerase chain reaction (RT-PCR). Point-of-care tests are currently used for flu and step tests, including systems by Abbott (ID NOW), Roche (Liat), and Cepheid (Xpert Xpress) mPOC-maker Cepheid says it is developing an automated molecular test for the qualitative detection of SARS-CoV-2. And Cepheid says it will try to utilize its tens of thousands of existing instrument placements. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and future pandemic coronavirus strains, we are developing a test that can be applied in multiple settings where actionable patient management information is needed quickly,” the company said.

Singapore POC maker Credo Diagnostics Biomedical announced this week that it has obtained the CE mark in Europe for an assay to detect SARS-CoV-2. The test runs on the firm’s platform, called VitaPCR, and the company said it uses PCR and runs the test in 20 minutes. The system needs minimal operator training to run and involves no additional equipment, according to Credo.

The company says the VitaPCR SARS-CoV-2 Assay is now also pending Emergency Use Authorization from the FDA and Emergency Use Listing from the World Health Organization.  While not as fast as immunoassays, the mPOC systems typically use isothermal amplification to achieve much faster turnaround than the regular lab-based RT-PCR tests. This is one of their biggest strengths, along with low. The following are some additional examples of molecular diagnostic systems and assays including POC and other technologies which are available or under development:

  • Aldatu Biosciences – PANDAA qDx SARS-CoV-2
  • Becton Dickinson (BD) – BD and BioGX submitted for EUAs on BD Max platform
  • BGI/ Pathomics Health – Fluorescent RT-PCR kit (CE marked); 2019-nCoV PMseq Kit
  • Bio-Rad – standards – synthetic COVID-19 RNA transcripts and human genomic DNA
  • bioMerieux/ BioFire Defense – FilmArray, BioFire COVID-19 Test
  • Biomeme – Go Strips for  COVID-19
  • BIONEER Corporation – AccuPower 2019-nCoV
  • Caspr Biotech – Phantom 1.0 Dx, disposable test usingCRISPR
  • Cepheid – Test in development for Xpert Xpress system announced; partnership for Sherlock Biosciences’ CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) engineering biology platform, to design tests to run on Cepheid’s GeneXpert systems
  • CerTest Biotec – VIASURE 2019-nCoV Real Time PCR Kit (CE mark for BD Max platform)
  • Co-Diagnostics – Logix Smart Coronavirus Disease 2019 (COVID-19) Test; single step rRT-PCR (CE mark)
  • Coyote Bioscience – Mini8 Portable Molecular Diagnostic QPCR Station (CFDA approved)
  • Credo Diagnostics Biomedical – VitaPCR platform, COVID-19 assay (CE mark)
  • Curetis/ OpGen/ BGI – RTPCR test kit for SARS-CoV2 (CE mark)
  • Diagnostics for the Real World Ltd – SAMBA II COVID-19 Test
  • GenMark – ePlex SARS-CoV-2 test; sample-to-answer system based on competitive DNA hybridization and electrochemical detection technology (RUO, with EUA submitted)
  • HiberGene – HG Swift, can use battery power, pursuing Fast Track Emergency Use in China
  • Integrated DNA Technologies (Danaher) – 2019-nCoV CDC EUA Kit
  • Jiangsu Qitian Gene Biotechnology Co., Ltd. – Fluorescent RAA Detection for 2019-nCoV
  • LabCorp – COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test (EUA issued)
  • LGC Biosearch – primer and probe kits for CDC Real-Time RT-PCR Diagnostic Panel
  • MiCo Biomed Co. Ltd – VERI-QTM PCR 316 COVID-19 detection system
  • Mobidiag – Novodiag COVID-19 + InfA/B – multiplex test for coronavirus and influenza
  • Molbio – TrueLab, Truenat SARS CoV-2 – TruePrep and TrueNAT instruments
  • Mologic – battery powered point-of-need diagnostic test
  • Novacyt – qPCR (CE mark)
  • OnSiteGene – Peak V
  • Pinpoint Science – SARS-Cov-2 test in partnership with Analog Devices
  • Qiagen – QIAstat-Dx, Respiratory Panel 2019-nCoV
  • QuantuMDx – Q-POC
  • RainSure Bio – DropX-2000 Digital PCR System, RainSure COVID-19 dPCR Detection Kit
  • Randox Laboratories Ltd – Extended Coronavirus Array
  • Seegene – Allplex 2019-nCoV assay (CE mark)
  • Sentinel Diagnostics – Stat-NAT COVID-19 assay
  • SolGent – DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (CE mark)
  • Twist Bioscience – NGS-based target capture for SARS-CoV-2 detection and screening
  • Ubiquitome – Liberty16, open mobile real time PCR system with 2-3 hour battery life

 

In addition to direct tests for SARS-CoV-2, Kalorama expects demand for flu tests to increase due to “rule-out” testing.

Right now, molecular is the focus for the current pandemic, but immunoassays also are in development. Molecular tests generally analyze the viral RNA in patient throat/nasal swabs, but there are other POC testing methods that use immunoassays to detect the patient’s COVID-19 antibodies in blood or serum. It appears there are roles for both mPOC and immunoassay POC tests as there are trade-offs between the two. Immunoassays generally suffer from a high rate of false negatives (low sensitivity), with some rare exceptions. Nonetheless, immunoassays can have comparable speci􀂦city and a varying combination of lower cost, faster turnaround, greater portability, and, thus, advantages in the context of larger-scale population surveillance, screening, and triaging of patients in outbreak situations.

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