02 June 2020

Rapid Diagnostics and Antibiotic Resistance

By Adam Hargreaves By Adam Hargreaves

Back in July 2004, the Infectious Diseases Society of America (IDSA) released a study called ‘Bad Bugs, No Drugs’ which investigated the decline in new antibiotic research and development. The paper went on to express concern about the future implications this could have.

At the time IDSA president Joseph Dalovisio commented,
 

‘Infectious disease physicians are alarmed by the prospect that effective antibiotics may not be available to treat seriously ill patients in the future’.



His, and the paper’s concern was that there are not enough new drugs in the pipeline to keep pace with drug-resistant bacterial infections, so-called ‘superbugs’.

Fast forward 16 years, and the problem has only got worse. In the US alone, a report by the Centers for Disease Control and Prevention (CDC) in March this year highlighted how 2.8 million antibiotic-resistant infections occur each year, leading to the deaths of more than 35,000 people. The numbers are mirrored in Europe, where it is estimated that an additional 25,000 people die each year from antibiotic-resistant infections.

It’s predicted that, without major change in treatment paradigms, deaths from ‘superbugs’ will surpass deaths from cancer by 2050. 

 

Antibiotic Resistance

 

Antibiotic resistance occurs when germs like bacteria or fungi cease to be affected by the drugs designed to treat them. These germs then become far more difficult (sometimes impossible) to treat.

The emergence of these infections can have huge ramifications outside the typical setting, i.e. where someone gets an illness and is given a drug to treat it. For example, many medical manufacturers rely on effective antibiotics being administered during procedures like joint or organ replacements, cancer therapy or in the treatment for chronic illnesses

With the problem worsening, new antibiotics and antibiotic research is urgently needed, but there is little incentive for biotech or pharma companies to explore this route. That’s because antibiotics are tightly controlled once they reach the market, and ROI for these types of therapies is lower.

Only 16 new antibiotics have received clearance between 2013 and 2020 and only 20% of clinical trials for infectious disease drugs have received clearance. In short, the superbugs are becoming resistant at a faster speed than the drugs can be developed.

To address to the problem, one suggested solution has been a ‘market entry reward’ which sees companies receive payments for period of time after the approval of a new antibiotic. It’s hoped that programmes like this could allay concerns over profit and ease the demand on public health.

 

The Role of Rapid Diagnostics

 

In 2010, the department of Health and Human Services gave the Biomedical Advanced Research and Development Authority (BARDA) the task of addressing the public health threat of antimicrobial resistance, with funding being made available to companies developing diagnostic tests.

More sophisticated testing can help with the deployment of antibiotics only where they are needed, rather than as a ‘one size fits all’ solution for any ailment, which gives the bacteria more opportunity to become resistant.

Companies such as Accelerate Diagnostics, BioFire Diagnostics and SeLux Diagnostics have created novel approaches for determining personalised antibiotic therapies for patients, including those with superbug infections, allowing tailored and effective treatment plans to be devised by physicians.

Advances in diagnostic tests have enabled health care practitioners to quickly distinguish infections that require treatment to those that do not. This is achieved by testing patients at the point of care and determining the appropriate treatment strategy at an earlier stage. This helps physicians distinguish between viral and bacterial infections as only the latter requires treatment with antibiotics.

This means better allocation of resources, faster and more effective patient treatment and a reduction in overall health costs and the strain on over crowded hospitals.

 

Genomics and Bioinformatics

 

OpGen's Unyvero System

One company dedicated to lessening the effects of antibiotic resistance are US-based precision medicine specialists OpGen. The team there are harnessing the power of molecular diagnostics and bioinformatics to help fight antibiotic resistance.

This means that they are able to identify the correct treatment for a patient’s infection, preventing caregivers from always prescribing broad-spectrum antibiotics empirically – i.e. in the absence of rapid diagnostic information - which may not be effective for the patient in question. Their approach combines genomics and bioinformatics to give a far more well-rounded picture of a patient’s condition.

Clinicians are then left with more rapid and actionable information about life threatening infections, leading to improved patient outcomes and a reduction in the spread of multidrug-resistant microorganisms (MDROs).

OpGen have received the CE mark for five different tests as well as FDA clearance for a pneumonia test, with a test for isolates currently going through FDA clearance and one for complicated urinary tract infections in the clinic, according to CEO Oliver Schacht.

They’ve recently merged with Curetis, strengthening their R&D portfolio and in 2020 to date raised more than $15M equity investment which they plan to put towards continuing innovation in the molecular microbiology space.

Unsurprisingly, my conversation with Oliver turned to the current COVID-19 crisis, as OpGen have also developed a solution in the form of a buffer solution compatible with for CoV-2 PCR testing which avoids the need for RNA extraction kits, saving time, resources and money.

 

COVID-19 and Antibiotic Resistance

 

Antibiotic resistance offers another layer of complexity to the treatment of COVID-19. It’s been reported that one in seven patients with the virus develop secondary infections, which has resulted in experts calling for COVID-19 patients to be tested for bacteria and fungal infections, particularly those at the highest risk with underlying health conditions.

Using sophisticated testing like that offered by OpGen means physicians who are under-pressure attempting to stop coronavirus can identify and treat these conditions effectively. This information can be gathered in less than two minutes ofhands-on-time, with results generated in less than five hours, keeping pace with the urgency of care needed to treat coronavirus.

Oliver from OpGen agreed that testing for antibiotic resistant microbes had a big part to play in fighting coronavirus:
 

Addressing the issue is simple. Fast and reliable testing panels and modern molecular diagnostic technologies already exist for these bacterial co-infections. Caregivers, doctors and advocates for the most at-risk populations should incorporate these into the COVID-19 care and treatment model moving forward to ease suffering and improve outcomes.


Even taking coronavirus out of the equation, antibiotic resistance is estimated to cause 50,000 deaths in the USA and Europe a year and health services in the US an additional $20 billion. It’s a huge issue which I hope the wider life science space will pay more attention to. The diagnostic testing market has recently demonstrated that it can act fast in a pandemic, but it’s also time to focus efforts on averting a potentially much bigger public health crisis in the next few years.

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Adam Hargreaves

Adam Hargreaves is a Business Consultant specialising within commercial IVD, focusing on US markets. Adam is a specialist at building teams and making sure new hires culturally align to company goals. Fascinated by his market, Adam is always keen to talk with experts and leading executives on the subjects that matter most to you. 

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