COPENHAGEN – Danaher subsidiary Cepheid is preparing multiple new test launches for a variety of infectious diseases including tuberculosis and respiratory viruses.
Beryl Oppenheim, senior director of medical affairs at Cepheid, laid out the firm's plans in a presentation at the 33rd European Congress of Clinical Microbiology and Infectious Diseases on Monday. Oppenheim cited changes in the technology of Cepheid's tests, namely the use of 10-color technology developed in collaboration with researchers at Rutgers University, which has allowed the company "to move forward with a much deeper multiplexing … for much wider infectious conditions and syndromes." The technology allows for the multiplex detection of 10 independent targets in one reaction.
The firm's Xpert MTB/XDR test, which detects resistance to six drugs used to treat tuberculosis, was the first assay to be launched using the technology in 2020 and is currently on the market. The technology "open[s] up the possibility of using this technology much more widely to move into other areas," such as broader respiratory virus and gastrointestinal panels.
Those specific panels are on the docket for launch in 2023 and 2024. The proposed respiratory panel will detect 10 viruses and four bacteria including adenovirus, coronavirus, SARS-CoV-2, rhinovirus, multiple kinds of influenza, respiratory syncytial virus, Bordetella pertussis, and Mycoplasma pneumoniae. The firm currently offers a multiplex respiratory virus test for SARS-CoV-2, influenza A and B, and RSV, which received Emergency Use Authorization from the US Food and Drug Administration in 2021.
It also intends to roll out a gastrointestinal panel that will detect eight bacteria including Campylobacter, Salmonella, Yersinia enterocolitica, and Vibrio cholerae, two parasites, Giardia lamblia and Cryptosporidium, and norovirus.
Cepheid has plans for multiple sexual health and oncology tests as well, she said.
The company's Xpert Carba-R test for detecting resistance genes in carbapenemase-producing bacteria, which received clearance from the FDA in 2016 and is on the market, will also be getting an upgrade. Currently, the assay detects five classes of carbapenem resistance genes from rectal swabs, perirectal swabs, and carbapenem non-susceptible colonies. However, Oppenheim said Cepheid is aware of emerging carbapenemases that are not included in the test, which will be updated to include some of the uncommon but "still very important and challenging carbapenemases."
Cepheid also aims to expand its tuberculosis portfolio with the potential addition of a fingerstick host response test. With a three-gene signature licensed from Stanford and modified by the firm's research and development team, and covered by a provisional patent, the assay will measure three messenger RNA genes and, depending on how the genes interact, return a score that indicates whether a patient is positive, high risk, low risk, or negative for TB. The test would help with diagnosis, triaging, and managing at-risk patients, Oppenheim said.