COVID-19 test kits

A run-down of various kit types out there

I decided to wade through news from the past few months and get an overview of the various types of COVID-19 test kits on the market or at least in advanced development. It’s a rabbit hole! I hope you’ll find the article as informative as I did researching and writing it.


It seems that after an initial frenzy at the start of the COVID-19 pandemic, when seemingly almost any old test could somehow make it on the market (check out the April news review for comments on quality issues), we’ve seen not just quality tests but also kits with added features appear from summer 2020. More and more COVID-19 tests have been developed and gained regulatory authorisations since I last covered them in my newsletter. It's time to sort through the news to get and idea of the types of kits out there.

Molecular tests aka PCR tests

Polymerase chain reaction (PCR)-based tests were the first to make it on the market as far as I can tell. We saw a surge of PCR kit releases from March 2020 onwards. They are considered the gold standard for testing because they can detect extremely low viral loads. These tests tell us whether a person is currently infected, which is important for quarantine and treatment decisions.

PCR kits detect genetic material from the virus in a sample (often a nose or throat swab). The reaction mix in those tests amplifies the available genetic viral material (RNA). This multiplication step reduces the need for large amounts of material being present in the original sample and, consequently, creates the high test sensitivity. Major drawbacks of the traditional PCR tests are that they take a long time to yield results with people being informed several hours after testing, require a professional lab and trained staff.

However, some organisations have simplified and sped up the process since the release of the early test kits. E&O Laboratories set out to make the manual process flow safer and more streamlined with its VPSS (Viral PCR Sample Solution), which simplifies and accelerates sample handling. Fluidigm has increased through-put per sample batch using microfluidics technology on saliva samples. DnaNudge's portable system yields test results from swab or saliva samples in just over an hour. These can be sent directly to a clinician via an integrated app.

Multiplex capabilities

As time went on, new PCR tests were released that didn't only detect the COVID-19 virus SARS-CoV-2 in a sample but also other viruses that can cause similar symptoms. Eurobio Scientific, QIAGEN, Thermo Fisher Scientific and BGI Genomics have released multiplex PCR tests that distinguish in a single run between main viruses responsible for flu-like symptoms. After having already released portable COVID-19 PCR test kits that yields results in under two hours, Oxford Nanopore Technologies has also begun developing a multiplex assay for respiratory viruses. Being able to distinguish between different viruses helps medical professionals give relevant advice to patients and supports our understanding of the dynamics between those infectious agents.

Rutgers researchers have developed a PCR test that can detect the three currently most notorious coronavirus variants in just over an hour and shared their method online. Seegene's assay takes this further, as it is designed to identify each coronavirus variant. Besides influencing potential treatment decisions, this is also important for monitoring the spread of such variants between populations and geographies.

At-home tests

There has been a drive towards home-testing kits, as this avoids the need for travel and potential spread of the virus by an infected person; it is also safer and reduces the need for healthcare staff. This in turn means that medical professionals, who would otherwise be seconded to COVID-19 testing, can take up their usual or other needed roles to cater for the plethora of other healthcare services, some of which had been put on hold due to the pandemic.

Alveo Technologies, GetMyDNA and LetsGetChecked have released home PCR sampling kits using nasal swabs. However, there is a risk that unsupervised swabbing is not done correctly or that the sample does not stem from the right person. Other companies went one step further and developed kits using saliva samples. This is intended to be more comfortable and reliable than self-swabbing. According to my radar, the first at-home saliva tests came from RUCDR Infinite Biologics and MicroGen DX.

Isothermal amplification-based tests

Isothermal amplification is a novel molecular technology that also uses amplification of genetic material but differs in various aspects from PCR. The mechanism is simpler, quicker and more cost-effective. Thanks to their relative simplicity, these novel kits require only minimal training of technicians.

Isothermal amplification is employed in MicrosensDx' and Abbott's portable point-of-care kits, which yield results in under 30 min. OptiGene has attracted some controversy when its loop-mediated isothermal amplification (LAMP)-based test missed about half of the positive cases in a Manchester trial, whereas other trials showed high sensitivity dependent on viral load in the sample.

NGS tests

Illumina has released a next-generation sequencing (NGS)-based test for swab samples. NGS is like PCR on steroids. In terms of routine COVID-19 testing, the main advantage of NGS is the higher through-put. Thus, it could scale up testing capacities quickly. For lower through-put PCR appears to be more economical. That said, the Sanger Institute is developing a cost-effective NGS test for saliva and swab samples with a view to making it suitable for rapid point-of-care and home testing.

Antigen tests

Antigen tests detect virus proteins usually in nose swab samples. Hence, like PCR tests, they tell us whether a person is currently infected. However, there is no amplification step for proteins as there is for genetic material. This means that enough of those proteins must be build in the body after virus infection before they can be reliably detected. This reveals one inherent disadvantage of antigen tests compared to PCR tests: lower sensitivity. These tests require a higher level of viral load to return a positive result. Consequently, there is a higher risk of false negatives, i.e. an infected person gets a negative test result. If there is doubt over the result, it may well be required to run a PCR test in addition.

One of the advantages of antigen tests is that they are usually easy-to-use rapid tests. Commonly, tests deliver results in 10-15 minutes and use lateral flow technology similar to pregnancy tests. Mondialab was early out of the starting blocks with its blood sample-based point-of-care kit. The test strips are machine-read to avoid human error and instantly create a digital record. Other tests generally use nasopharyngeal swabs sampled by professionals or under supervision, such as kits released by Siemens Healthineers, SD-Biosensor, Roche and Humasis/Celltrion . Abbott released its Panbio COVID-19 Ag kit for professional use and took it a few steps further with its BinaxNOW™ COVID-19 Ag Card. It comes as a professional use or telehealth-facilitated home test. The kit allows the transfer of results from a test card to a mobile app that provides people who test negative with a temporary encrypted digital health pass. A low-cost telehealth-facilitated home test kit is offered by LABx Corp. Pelican Diagnostics' saliva kit is super fast (results in 30 sec) with a sensitivity rivalling PCR tests thanks to nanosensor technology. It is suitable for home and professional use and can be hooked up to a mobile app to store and share results.

Serological tests aka antibody tests

Antibodies are produced by white blood cells, called B cells, that are part of our adaptive immune system. Serological tests detect antibodies against SARS-CoV-2 usually in blood samples. This tells us whether the person has ever been infected because antibodies are part of our immune defence and persist for some time even when the virus is gone. Generally, they take about 1-2 weeks to appear in the body at detectable levels because our immune system needs time to generate an anti-viral response. Thus, a newly-infected person does not yet have antibodies but will have genetic virus material. In contrast, a person who has overcome the infection, may not have detectable genetic material anymore but will probably have antibodies. Hence, correct timing of these different tests is crucial to avoid false negatives.

Results from antibody tests are informative in several ways:

  • They help epidemiologists understand how many people in a population have been infected. Since not everybody experiences symptoms or gets a PCR test when feeling unwell, it is impossible to have reliable estimates. Without such information, fatality rates (how many deaths per infected number of people) cannot be reliably calculated. This means that we cannot know how serious the infectious disease really is. This, in turn, makes it difficult to set effective and efficient healthcare policies.

  • Knowing how many people have had the virus, and how it is spreading also informs vaccination programmes.

  • They are a tool to assess how effective a vaccine is because a vaccine is supposed to stimulate an antibody-mediated immune response.

  • They can also help assess for how long immunisation by vaccination or natural infection lasts.

  • Identifying people with a strong antibody-mediated immune response helps find potential convalescent plasma donors whose antibodies may save patient lives.

  • Knowing which healthcare staff is considered immune, i.e. tests positive for antibodies, can help allocate frontline care tasks, such as intubating an infected patient.

Soon after PCR kits, more and more serological kits started appearing on the market. Following concerns about the quality of early kits, the FDA tightened its enforcement, issued a ‘removed’ list, and later tests have been promising sensitivity and specificity at or near 100%. In addition to 'basic' serological tests, some interesting ones have been developed. Researchers from the University of Illinois created a rapid low-cost COVID-19 antibody test chip that does not require diagnostic laboratories. The University of Exeter spin-out Attomarker has developed a multiplex point-of-care Triple Antibody Test that can be connected to mobile devices. This test detects 3 classes of antibodies (IgM/G/A) against 3 virus proteins. Many serological tests seem to simply detect any virus-specific antibody. This only really tells us that the person has been infected previously. Duke-NUS Medical School has developed a test that specifically detects neutralising antibodies. These are the antibodies that inactivate the virus and can give us some idea of antibody-mediated immunity, which is more informative for the choice of convalescent plasma donors for example. Microfluidics-facilitated portable rapid kits might also be an option for rapid COVID-19 antibody testing in very small sample volumes.

CRISPR tests

Researchers at NTU Singapore have developed a rapid COVID-19 test that can detect even mutated virus variants in nasopharyngeal swab samples using the gene-editing tool CRISPR. This is important because SARS-CoV-2 is highly mutable and tests must keep up with mutations to avoid false negatives. Briefly, the test uses molecular 'scissors' that recognise specifically defined and conserved (i.e. low mutation risk) parts of the viral genetic material. The scissors only get activated in the presence of the virus RNA and, at the same time as cutting the virus material, also cleave a detection reagent that starts to glow as a result. This light emission signals the virus detection when analysed by a reader in the lab version of the test. In addition, there is an easy-to-use paper strip version (think pregnancy test) and a mobile app that assists in interpreting the paper strip detection bands. TATA Sons have already gained approval in India for their point-of-care CRISPR paper strip kit. An original protocol had been published by US researchers through the COVID-19 Technology Access Framework.

Breath tests

Breathonix is developing a one-minute breath test detecting exhaled Volatile Organic Compounds (VOC), which can indicate changes in a person’s breath profile due to disease. The analyser uses machine learning algorithms. Scientists from Vancouver's BC Cancer Research Institute are working on a similar project. Breathomix has also developed a rapid breath analyser and launched an initial roll-out in Amsterdam, NL in Feb 21. It is expected to be reliable for negative results. However, positive reads must be backed up by PCR test until more usage data are available to confirm whether the kit can distinguish between different virus infections.

T cell assays

T cells are white blood cells and part of our adaptive immune system. They do not produce antibodies but are critical in the activation cascade that simulates B cells to produce antibodies. Information on the behaviour of T cells can be used to determine whether a person has had the virus previously or is harbouring a latent infection. Further applications are ongoing immune monitoring and determination of the strength and longevity of the immune response to natural infection or vaccination. Improved understanding of the different phases of the immune response can inform medical decision-making and further research into diagnostic, prevention and treatment strategies of COVID-19.

Hence, some companies have laid their eyes on testing T cell activity to complement other tests mentioned above. Oxford Immunotec's assay measures the T cell-mediated immune response to SARS-CoV-2 using blood samples. It has gained regulatory approval in different countries for research use only. Sysmex and Kobe University have released data on their joint research, which shows that the test measures virus-specific T cell activity. BD's multi-colour test kit identifies and enumerates T cell subtypes. It has been approved for clinical application in Europe. Adaptive's FDA-authorised NGS kit uses Microsoft's artificial intelligence (AI) for genetic analysis of T cells to determine past infection and immunological 'memory'. Note that the virus NGS tests mentioned earlier target virus RNA, whilst Adaptive's kit analyses T cell DNA. NGS technology can be used with genetic material from various sources.

Machine learning & AI

Vertebrate Antibodies is developing a COVID-19 antibody test suitable for mass screening using AI to identify virus components that trigger an immune reaction. These are then used to capture antibodies in the sample to yield a positive result should the relevant antibodies be present.

Now that test accuracy is not a major concern anymore because of the high quality of existing kits, speed has increasingly become a key discriminator. iAbra's 20-second test could be a complete game changer. After a trial at Heathrow airport, iAbra is now eyeing up proper roll-out. The start-up is backed by Dell and Intel. The technology takes a novel diagnostic approach based on AI-driven microscopic holographic imaging. A digital camera feeds data from saliva samples under a microscope to the trained AI, which identifies the infection.

Blockchain tracking

Blockchain isn't just a buzzword anymore, and its uses go way beyond cryptocurrency. Kahala Biosciences & Rymedi collaborated early on in the pandemic to bring us a rapid point-of-care antibody test (IgG/M) that is connected to a blockchain-enabled mobile app to provide a tamper-proof record of kit provenance, test results and symptom tracking. Since then, more organisations have been looking to leverage blockchain technology for authentication of test kits and results; latterly these include healthcare provider Innova Medical in collaboration with Quantum Materials Corp, Singapore's government, Emirates airline and lab service Arion Genetica in collaboration with tech start-up Genobank.io.


Disclaimer

The organisations mentioned are simply examples I have spotted in the news. This article does not aim to offer a comprehensive list of relevant organisations or test kits.

Spiffin’ coronavirus vaccine

Welcome to the new version of Blue Steens' newsletter

Hi there,

if you’ve been a subscriber for a wee while, you’ll notice that the format of the ensuing newsletter is different from previous releases. After taking some time to think about how to keep this newsletter a manageable and enjoyable task, I decided to try out a new approach. The idea is to focus on one or few pieces of biopharma news and explore this in more detail. I’ll aim to release an article at least bi-monthly.

If you enjoy the new format, don’t hesitate to tell others about the newsletter. If I’ve turned you off, there’s always the unsubscribe option. I’ll be sorry to see you leave though. I’m curious about your feedback, too!

Let’s see how it goes. :)

All the best,

Chris


Spiffin’ coronavirus vaccine

The purpose of a vaccine is effectively to train the immune system in recognising and combatting the virus quickly should there ever be a real infection. To do so, vaccines deliver virus components, which are harmless on their own, to the recipient’s immune system. These components are referred to as immunisation targets or immunogens. Once immune cells recognise and bind to these, an immune response follows.

There are a few different vaccine technology platforms in use or development. Here, I very briefly summarise the ones used for COVID-19 vaccines and then highlight one novel approach that has piqued my interest.

Vaccine development ideally targets highly conserved regions of a virus that are known to elicit an immune response. These are parts of the virus that it cannot afford to mutate too much because it risks losing its infectious power. For example, this could be a protein that enables the virus to attach to human cells to infect its new host (like the SARS-CoV-2 spike protein we keep hearing about - although this is known to mutate). Theoretically it is possible that there are transient virus versions that have significant mutations in such areas, but we might never know because those viruses have incapacitated themselves and, thus, never infect anyone or only few susceptible people.

Note that there is no intelligence behind these mutations. They simply happen and are either beneficial, detrimental or neutral for the virus. It does not decide to mutate.

COVID-19 vaccines

Currently, a few vaccines keep making the headlines, as they have made it onto the global market or are close. They fall into four technological categories. The vaccines from Pfizer-BioNTech and Moderna are mRNA-based. Oxford-AstraZeneca’s, Johnson & Johnson/Janssen Pharmaceuticals’, CanSino Biologics’ and Russia’s Sputnik V use DNA vectors. All of these vaccines essentially deliver the genetic information necessary to instruct the recipient’s body to produce harmless virus components. The protein-based vaccines from GSK-Sanofi and Novavax aim to deliver ready-made virus components to the immune cells without the body having to build them first. The vaccines from Valneva, Sinopharm and Sinovac use inactivated coronavirus, which aims to provide the most native and complex presentation of virus material to the immune system. Presentation is key for a vaccine to be successful.

The spiffin’ vaccine

In amongst all the big news, I noticed an article about a protein-based COVID-19 vaccine candidate under development by the US Army. It is referred to as SpFN (spike ferritin nanoparticle). What piqued my interest was that the vaccine is multivalent, i.e. it can display multiple binding sites to immune cells on one vaccine molecule. Imagine a football where each hexagon and pentagon represents a binding site.

Why is this important?

The most effective protein-based vaccines so far have been those that mimic a virus structurally to some degree. This is possible through the use of technologies that facilitate the clustering of immunogens into small particles, i.e. nanoparticles. Immunogens are the parts of a virus that our immune cells need to detect to mount their defence. The superiority of nanoparticles over vaccines that use smaller molecules (soluble subunit vaccines) has been attributed to our immune system working best when it sees immunogens presented in a repetitive dense pattern just like on a real virus. Imagine looking at a 3D puzzle. You can maybe gauge what the final sculpture is supposed to be when the pieces are strewn across the floor, but once larger sections of the puzzle have been completed, you know much better what it’s meant to be. It is all about context, even for our immune cells.

A multivalent vaccine

SpFN employs ferritin as its key base component. This is a common protein in living organisms with 24 structural sites and is one of the better-researched platforms to create multivalent vaccines. It can be isolated from bacteria and engineered to suit in the lab. The idea of using ferritin as a vaccine particle base is not specific to COVID-19. It has also been researched for HIV-1 and influenza, for example.

Ferritin molecules can be fused to viral proteins. The resulting constructs self-assemble to form a virus-mimicking particle that displays viral proteins on its surface (think football). The result is a multivalent vaccine that offers a repetitive pattern of binding sites to stimulate immune cells. Research suggests that the use of more than one immunogen on the same ferritin construct may elicit cross-reactivity against related viruses, e.g. various coronaviruses.

It can be speculated that the use of more than one immunogen may also reduce the risk of vaccination failing due to virus mutations because one vaccine covers various viral targets. Thus, the chances are higher that the recipient mounts an immune response against several, if not all, of them. When the virus mutates one of those targets ‘in the wild’, the vaccinated human should still be able to defend themselves thanks to their immune system recognising other viral properties that have not mutated yet. This, in turn, would reduce the spread of new virus versions amongst the population and, ideally, mitigate further virus mutations. There will be limits of the number of viral proteins that can be used per ferritin construct, as the presentation density for each of them must be optimised to elicit a robust immune response.

In conclusion, vaccine nanoparticles offer a tool that enables us to present immunogens to immune cells in a 3D structure that mimics a real virus. If designed well, they elicit robust immune responses. One benefit is that there is no need for the use of inactivated viruses. Thus, this novel approach promises to be safer. Note that ferritin fusion is only one way of building vaccine nanoparticles. Novavax, for example, also employs nanoparticles in its COVID-19 vaccine but uses a different technology.


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In this newsletter I share personal views and observations only. For more information and the privacy policy visit Blue Steens.

Blue Steens in October 2020

Catch up on Blue Steens articles and venture further

This month on Blue Steens

Quo vadis?

Career support is often readily offered to young people. What about mature career changers? I feel that we don't make enough use of cross-disciplinary and intergenerational wisdom.

Read >>


Beyond Blue Steens

Coronavirus

⊳ Testing

⊳ Treatment

⊳ Vaccination

Biotech

Out and about

1 Oct: HUG Standards. Global Collaboration and Harmonization for Digital Transformation in Health Care, Science Digital @ UNGA 75 [general resources]
7 Oct: IEEE Healthcare: Blockchain & AI Kick-off [replays]
13 Oct: MediLedger Webinar #7: An Implementation Walkthrough of a Blockchain-based Solution for Chargebacks in Life Sciences [replay]
13 Oct: BRG Webinar - Enterprise Applications: Ethereum & Baseline Protocol [replay]
15 Oct: Episode 008 Enterprise DLT Live, Philip Baker, RemediChain [replay]
27 Oct: Blockchain in Use: Internet of Things (IoT), BerChain [replay]
28 Oct: How Public Blockchains Will Reshape Industry Supply Chains & Competition [replay, slides, case study]
30 Oct: ConsenSys Health with Mike McCoy, Memphis Blockchain Distributed Ledgers [replay tbc]
31 Oct: Discussion on Enterprise Blockchain Governance, GBA UAE [replay tbc]

*** If you made it down to this point, thanks for reading this far! Just a wee heads-up; there’s not going to be a November edition, as I’ll be too busy to give it the attention it requires. I’m also contemplating the future of this newsletter thereafter. ***


Connect on Twitter, LinkedIn or YouTube if you like.


In this newsletter I share personal views and observations only. For more information and the privacy policy visit Blue Steens.

Blue Steens in Aug-Sep 2020

Catch up on Blue Steens articles and venture further

Dear reader,

I didn’t forget about you last month! August was incredibly busy and intense. So, I decided to postpone and combine the August and September newsletters. Thank you for your patience! 💐

Aug/Sep on Blue Steens

Plasma vs virus

Convalescent plasma (CP) therapy gained FDA emergency use authorisation (EUA) in August. This is surrounded by some controversy and suspicion of politicisation. The FDA hasn’t been doing too well on that front lately. Others have offered sufficient critical thoughts on those aspects. I decided to cut out the noise in writing my commentary.

Read >>

Animaker

I took some time to chill in September and played with Animaker, a video animation creator. Loads of features in the free version. The interface is fairly intuitive and has a Canva feel to it. Both platforms look great for marketing on a low budget.

You may have noticed my “happy dance” animation elsewhere. In my next trial I created a little teaser for this very newsletter. Enjoy!


Beyond Blue Steens

Coronavirus

⊳ Testing

It seems that after an initial frenzy when seemingly almost any old test could somehow make it on the market (check out April edition for comments on quality issues), we’re now seeing quality kits with added features appear (see also July & June editions).

  • Abbott’s latest COVID-19 test has received FDA EUA and is quickly being snapped up. Point-of-care 15-minute antigen test that detects an active infection from nose swabs. Results are transferred to a test card that uses lateral flow technology for analysis. (FYI, pregnancy tests also use lateral flow.) The card can be hooked up to a free mobile app that provides people who test negative with a temporary encrypted digital health pass.

  • Pioneering Triple Antibody Test developed by University of Exeter spin-out Attomarker can give accurate quantitative results in 7 min. It has received MHRA approval. Developed as point-of-care test to be connected to mobile devices. Unlike other COVID-19 kits that only detect 1 biomarker, this test detects 3 virus proteins and 3 classes of antibodies (IgM/G/A). Thus, it gives an indication of current and past infection.

  • Eurobio Scientific and BGI Genomics obtained CE mark for multiplex PCR tests that distinguish in a single run between main viruses responsible for flu-like symptoms.

⊳ Treatment

  • Drug repurposing has drawn lots of attention during this healthcare crisis. - Eli Lilly's rheumatoid arthritis drug baricitinib (Olumiant) accelerates recovery when used in combination with remdesivir. After mixed results previously, placebo-controlled phase 3 trial of flu drug Avigan also promises faster recovery (see also May & July editions).

  • Big-name consortia are definitely on the rise. Here’s a recent example: The COVID R&D Alliance (Amgen, Takeda, AbbVie & 18 others) is recruiting hospitalised patients to test 3 different drugs.

  • AI tool in development to predict disease course and customise treatment to reduce mortality.

Passive immunisation:

⊳ Vaccination

⊳ Blockchain

Biotech

  • Blood test for prostate cancer determines cancer presence and stage with 99% accuracy based on immune system markers. This will improve detection of early cases and reduce need for invasive biopsies and scans.

  • Painless biodegradable microneedle patch developed at University of Tokyo as simple, low-cost test for prediabetes screening. The needles are porous to allow fluids to be absorbed from the skin and travel to the paper sensor, which changes colour according to glucose levels. Human trials pending.

Medtech

  • B-Temia’s exoskeleton helps stroke patients walk by detecting movements and supporting these with motors.

  • CereGate aims to use ‘mind writing’ with computer-brain interfaces to help patients with neurological disorders or sensory deficits. After successful proof-of-concept study this year and new financing, they are heading in the direction of clinical trials.

  • AIgnostics develops histopathological AI-based image analysis for routine diagnostics and drug development. The tool handles black-box AI limitations by providing outputs that are verifiable by medical specialists.

Miscellaneous

  • Novartis issues EUR 1.85 billion sustainability-linked bond.

  • Insightful: COVID-19 is not a pandemic - “Approaching COVID-19 as a syndemic will invite a larger vision, one encompassing education, employment, housing, food, and environment.”

Out and about

13 Aug: Episode 006 Enterprise DLT Live - Carsten Stöcker, Spherity [replay]
26 Aug: COVID-19 Veterans Health Summit, ConsenSys Health [playlist]
15 Sep: Distributed Healthcare Interoperability and the Coalesce Health Alliance [replay]
17 Sep: Towards a US Research Data Framework, STM [replay]

Connect on Twitter, LinkedIn or YouTube if you like.


In this newsletter I share personal views and observations only. For more information and the privacy policy visit Blue Steens.

Blue Steens in July 2020

Catch up on Blue Steens articles and venture further

This month on Blue Steens

It’s not an immunity passport

There seems to be a perception that a Covid-19 immunity passport is the same as a vaccination passport. This is not so. The choice of words matters!

Read >>


Beyond Blue Steens

Coronavirus

⊳ Testing

  • 🏴󠁧󠁢󠁳󠁣󠁴󠁿 We talk about PCR testing but don’t consider the ins and outs much. Here’s a Scottish firm that makes samples safe and, in doing so, streamlines testing.

⊳ Treatment

(Hydroxy-) Chloroquine:
  • The WHO has stopped its hydroxychloroquine and lopinavir/ritonavir (HIV drugs) trials in hospitalised patients. See March, May & June reviews for previous news. Both trials were discontinued due to insignificant reduction in mortality. Trials in non-hospitalised patients continue. However, lopinavir/ritonavir might cause heart problems.

Remdesivir:
  • USA has bought Gilead’s global stocks for July to Sep. If generics (see also June review) don’t come out quickly and their distribution isn’t widened, the rest of the world will barely get any supplies for the time being.

  • EMA has recommended conditional approval for treatment of severe cases.

Passive immunisation:
  • South Korea approves trials of Celltrion's neutralising antibody treatment (see also June review)

  • Last month I reported on cows producing human antibodies. This month I discovered that engineered llama antibodies have been found to neutralise the virus. As bizarre as this may sound, these are not the only animals whose antibodies have captured researchers’ attention. For example Elasmogen, an Aberdeen (Scotland) company, makes use of engineered antibody-like molecules inspired by sharks. They are also looking into developing COVID-19 applications. 🏴󠁧󠁢󠁳󠁣󠁴󠁿

Anti-inflammatory treatment:
Other:
  • Inconclusive results from favipiravir (Avigan) Japan trial but promising results in India phase 3 trial (see also May review).

  • Novartis launches first-of-its-kind not-for-profit portfolio of medicines for symptomatic treatment. 15 generic and OTC medicines to be sold in up to 79 countries.

  • I try and steer clear of vague suggestions of potential treatments. However, EPO has caught my attention because it highlights something that’s fundamentally flawed in the prevailing drug development incentive system. There’s anecdotal evidence and academically founded hypotheses that EPO can improve the COVID-19 disease course. The problem is that there’s little incentive for pharma companies to get interested because there is no more patent protection.

  • FDA’s Coronavirus Treatment Acceleration Program (CTAP) website has some nice infographics and charts that track therapeutic developments.

⊳ Vaccination

Biotech

  • Takeda & Carmine Therapeutics join forces developing and commercialising a novel non-viral rare disease gene therapy that uses a red blood cell extracellular vesicles (RBCEV) platform. RBCEV are thought to avoid side effects seen with the traditional virus-based approach, allow repeat-dosing, can carry more genetic material and be modified to improve distribution in the body.

  • EMA approval for Bristol-Myers Squibb’s first-in-class anaemia drug Reblozyl (luspatercept) for patients dependent on blood transfusion. It is an erythroid maturation agent that supports the patient’s body in producing its own red blood cells.

Out and about

I find myself in loads of online events these days, some of which kindly release their replays. In addition to hyperlinking these below, I have started compiling my favourites and other relevant videos I come across in a blockchain playlist on YouTube.

1 July: VC Investment into Blockchain- MMC Ventures on Why Blockchain and Why Now [replay]
2 July: A Framework for Blockchain Interoperability [replay]
2 July: Enterprise DLT Live Episode 003 - Luis Macias, GrainChain [replay]
9 July: Accelerating Clinical Trials by Leveraging Blockchain Technology Solutions [replay]
15 July: Book Talk Session 1: COVID-19 and Blockchain for Medical Research [replay]
16 July: Enterprise DLT Live Episode 004 - Darrell O'Donnell, CULedger [replay]
21 July: Acceleration of Remote Clinical Trials Using BlockChain [replay]
  • There’s a nice wee video about halfway through the session that demos the blockchain solution. Overall, I preferred the recent Health Unchained podcast with Rama Rao (CEO Bloqcube) on the topic though:

22 July: Reassessing life sciences supply chains to increase pandemic resilience and governmental actions [register for replay]
22 July: Book Talk Session 2: Blockchain for Medical Research [replay]
27 July: STOP COVID-19 Hackathon: What's Next? [will hyperlink if replay becomes available]
29 July: Pandemic Impact & Future of Blockchain [replay]
30 July: Episode 005 Enterprise DLT Live - Adam Krellenstein, Symbiont [replay]

Connect on Twitter, LinkedIn or YouTube if you like.


In this newsletter I share personal views and observations only. For more information and the privacy policy visit Blue Steens.

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