The Challenge

Infectious diseases have historically been diagnosed based on positive lab cultures. This is usually followed by antibiotic treatments, which have proven unnecessary and counterproductive sometimes. It’s important to note here that a negative lab culture is not always evidence that pathogens are absent. And neither does a positive culture mean the right antibiotic will be prescribed. 

“Clinicians tend to throw everything at an infection hoping it goes away. There is only so much you can do with that type of approach before it catches up with you,” says Banks.

Treating infectious illnesses this way has led to the rise of antimicrobial-resistant pathogens that are incredibly difficult to treat. Antibiotic/antimicrobial resistance (AR/AMR) is a leading public health concern in the United States with at least 2.8 million people contracting an antimicrobial-resistant infection each year, resulting in more than 35,000 deaths.

Because qRT-PCR detects the presence of pathogenic nucleic acids, lab professionals can detect a latent infection before cultures become positive.

CardioPath was on the market for syndromic panels they could use in their testing. They found that buying assays for different diseases from other companies was a disjointed and confusing process. “When we started researching syndromic panels, we found that the products from top competitor companies were not vertically integrated. Yes, you could get an assay but then you would need twenty other components to make it work,” says Banks. 

For the companies that had something close to what CardioPath was looking for, the platforms were designed as point-of-care solutions. CardioPath, on the other hand, needed a medium to high throughput solution that was scalable, customizable, and easy to use.

Seamless High-Throughput Integration with Just One Step

“With Seegene, what attracted us most was that everything you needed for that reaction
to be successful - from pre-analytical to post-analytic processes - was vertically integrated
and at the high throughput we were looking for,” says Banks.
“They serviced all of our needs while reducing operational overhead expenses significantly.”

CardioPath Laboratories currently uses the Seegene STARlet liquid handling system with a CFX96™ Real-Time PCR system*. They routinely run testing LDT validated protocols using Seegene’s
Allplex™ 2019-nCoV (SARS-CoV-2) Assay (EUA), Novaplex™ Respiratory Syndromic, Gastrointestinal and Urinary Tract Infection Panels (all currently available Research Use Only in the United States).

CardioPath chose to work with Seegene for two core reasons. The first was access to a wide variety of syndromic panels, including assays for gastrointestinal, respiratory, and urinary tract infections which are all integrated and can be used seamlessly with the Seegene STARlet and CFX96™ Real-Time PCR System using a one-step approach and can be validated for LDT use.

Image showing Seegene’s STARlet instrument set up at CardioPath Laboratories
Image courtesy: CardioPath Laboratories

 

The second key differentiator was the personable and collaborative customer service.
“Since the pandemic began, most companies have had a robotic stance and as a customer, it is easy to
feel like a number. The relationship with Seegene, on the other hand, was highly personable.
From the CEO to the field service engineers, there has always been that human element
in our relationships. We don’t feel like just another account with Seegene,” said Banks.

Improving Patient Outcomes with Early Pathogen Detection

CardioPath uses qRT-PCR to process COVID-19 patient results in three to four hours, rapidly identifying the specific offending pathogen. This is tremendous for clinical labs, treating clinicians, and ultimately for patients because lab professionals can pinpoint the presence of a pathogen – regardless of culture results. This allows clinicians to prescribe the right medication in a timely manner before the infection gets worse. This speed and precision can shorten hospital stays or eliminate the need for in-patient care entirely.

In an example shared by the founder and CEO, an elderly patient who was ill was tested for COVID-19. The patient’s results were negative for SARS-CoV-2; however, qRT-PCR showed the DNA signature for bacterial pneumonia (commonly caused by Streptococcus bacteria). A few days later, an X-ray showed that the patient had full-blown pneumonia which had not been detected via regular culture. In this case, a simple targeted antibiotic would treat the infection early, improving patient outcomes and

Broader Accessibility

CardioPath continues to expand its services, with a reliable supply chain and an integrated workflow. For Banks, the efficiency of having assays, instrumentation, reporting, and analysis running through a single platform drives significant efficiency. This, in turn, makes molecular diagnostics that much more accessible for everyday applications. The pandemic has taught us the value of high-throughput testing. This is driving renewed interest in molecular diagnostics and testing in many other fields.