Last week, Boston-based SeLux Diagnostics handily beat a milestone deadline to earn additional funding from the Biomedical and Advanced Research Authority (BARDA). SeLux will receive $11.4 million from BARDA, the second payment of a potential $45 million, to advance its rapid microbe identification and antibiotic susceptibility diagnostic. SeLux believes the device will personalize treatments and help put the brakes on antibiotic resistance.
“How do you make sure the minimalist antibiotic is used, and we reserve those super powerful broad-spectrum antibiotics for future needs?” asked SeLux CEO Steve Lufkin in a phone interview. “The way you do it is with diagnostic information, providing guidance to clinicians about which drug will work for that specific patient.”
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Lufkin believes current susceptibility testing takes too long – three to five days. During that period, patients are often treated with broad-spectrum antibiotics to ensure all bases are covered.
“The good news is, it’s going to save your life,” said Lufkin. “The bad news is, it’s going to cause side effects, including generating multidrug-resistant bacteria.”
Antibiotic resistance is becoming a serious problem, with some projecting these bugs could kill more people than cancer by 2050.
SeLux’s goal is to cut the wait time from days to hours. The company believes this information will inform better clinical choices and reduce reliance on the most powerful antibiotics – preserving their potency for the long-run.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The SeLux technology is built on a surface-binding assay that does a better job tracking bacterial deaths as they encounter effective antibiotics. In addition, the device is being designed to test as many as 50 drugs at once. The ultimate goal is to identify the best drug in around six hours.
“The reason six hours is significant,” says Lufkin, “is that, if you think about the shift work of a microbiology lab, it allows the lab to get the results of both the identification and the susceptibility testing of the patient sample in one shift.”
In addition to BARDA, SeLux has been working closely with the CDC & FDA Antibiotic Resistance Isolate Bank, which shares antibiotic-resistant microbes with researchers, life sciences companies and hospitals to help them develop the most effective countermeasures.
“If you’re developing a test to detect resistance or determine if an antimicrobial is effective in treating an infection, you want to have access to challenging organisms, early in the development process, to make sure your test works,” said Jean Patel, who founded the bank and worked at the CDC for 17 years, in a phone interview. Patel is now a principal scientist for Beckman Coulter Microbiology.
“This will make sure that any new test is accurate for detection of resistance and delivers the right results for patient care,” Patel said.
SeLux has taken full advantage of the bank, using around 750 samples to validate its technology. For a small company like SeLux, having access to the isolates bank has been a huge boost.
“You can fool yourself with the standard easy-to-run samples, but the challenge is that you really want to take a look at those resistant bugs and make sure you can call them at the same pace you’re calling the easy bacteria,” said Lufkin. “Having access to the isolate bank has allowed us to challenge our system. We can test assay performance, speed and all those key attributes.”
In addition to funding, BARDA is also providing technical support. The new milestone payment will help SeLux move into clinical trials, which are slated to begin sometime this fall.
Photo: Bill Oxford, Getty Images
