New Genomic Tests Aim to Diagnose Deadly Infections Faster

Another Boston company, Selux Diagnostics, started five years ago in a makeshift lab in the attic of its founder, Dr. Eric Stern, has developed a dishwasher-size machine that can test pathogens against a panel of 60 antibiotics and determine which ones are most likely to work. Unlike standard antibiotic susceptibility tests that take three or more days, Selux’s powerful algorithm can yield results within hours of a pathogen being identified from a patient sample.

Dr. William J. Muller, a pediatric infectious disease specialist at Ann Robert H. Lurie Children’s Hospital in Chicago, has used the test created by Karius more than 200 times over the past three years, and said he was impressed by its ability to diagnose lung infections. The test results, he said, have the potential to spare patients lung biopsies, which involve some risk and often yield inconclusive results.

“Anything that reduces the need for painful, invasive procedures should be welcome by hospitals,” said Dr. Muller, who has collaborated with Karius in the past and recently published the results of his findings in the journal Open Forum Infectious Diseases.

In a separate study published in December in JAMA Oncology, doctors at St. Jude Children’s Research Hospital in Memphis found that the test was able to predict the onset of life-threatening infections in pediatric leukemia patients three days before the onset of symptoms.

Dr. Amy P. Abernethy, principal deputy commissioner at the F.D.A., who oversees the regulation of new medical devices, said speed remained a concern, given that many of the companies seeking the agency’s approval operate proprietary labs, meaning that doctors must send off a blood, urine or fecal sample by overnight mail. That can add a day or more to the sequencing and diagnosis process, a lag that can be fatal for sepsis patients.

“We have a fair amount of excitement over next-generation sequencing, but we do acknowledge a few practical hurdles we need to get over,” she said in an interview.

Article source: https://www.nytimes.com/2020/02/24/health/genomic-diagnostic-tests.html