Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Infectious Disease Diagnostics topic
No spam. Unsubscribe anytime.
Researcher tells Senate committee genomic testing can find infections missed by culture; cites SUNY Downstate study
Summary
Dr. Niam O'Hara told the Senate Committee on Women’s Issues that clinical metagenomic sequencing identified pathogens in 63% of 200 culture‑negative patients in a SUNY Downstate study and warned that regulatory and reimbursement barriers limit patient access to such diagnostics.
Dr. Niam O'Hara, an evolutionary biologist who identified herself as CEO of BioSHEA and a research assistant professor at SUNY Downstate State Health Sciences University, told the Senate Committee on Women’s Issues on May 21 that clinical metagenomic sequencing can identify infections that standard culture misses and that broader use could improve care for women with recurrent urinary and pelvic infections.
"We're a Cornell spin out company, and we are fully focused on infectious disease diagnostics," O'Hara said, describing BioSHEA’s work in urine‑based genomic testing. She explained clinical metagenomics as extracting DNA or RNA from a sample, sequencing it, and matching the genetic "A's and T's and C's and G's" against databases to identify pathogens that do not grow in traditional culture.
O'Hara cited a SUNY Downstate study of 200 inpatients with UTI symptoms who were culture‑negative: using a genomics‑based approach, her team identified urogenital pathogens in 63% of the patients that standard culture had missed, and she said 70% of the patients had been prescribed antimicrobials that showed no activity against the detected organisms. "A lot of the patients we found ... actually had a fungal infection, and they were being treated with antibiotics," she said, arguing that better diagnostics would reduce inappropriate antibiotic use and the rise of drug resistance.
Regulatory and reimbursement hurdles
O'Hara described regulatory review and payer fragmentation as the principal barriers to adoption. She said her group’s urine assay required a 19‑month review in New York because it included an AI component and noted that coverage varies across Medicare Administrative Contractors (MACs), leaving some states without coverage. She also reported, referring to recent industry news, that a publicly traded diagnostic company pulled a UTI test after Novitas retroactively changed coverage and demanded repayment of $10,000,000; that account was presented as a company/market claim rather than as an independently verified fact.
Access and care pathways
O'Hara urged partnerships with telehealth providers and clinicians to expand access, noting shortages of specialists for recurrent UTIs and inequities in care access: "People are flying to London because there's a doctor there that you can get a vaccine that helps with this," she said, illustrating how advanced options may be available only to patients who can travel.
Committee context and next steps
The chair thanked O'Hara and said the committee would continue the conversation. O'Hara recommended further clinical studies to demonstrate health‑economics benefits, broader coverage decisions, and clearer regulatory timelines to encourage investment and broader uptake of advanced infectious‑disease diagnostics.
