Lophius Biosciences, Regensburg, Germany, has received approximately $3.4 million in new financing to accelerate development and marketing of a blood-based tuberculosis detection assay on its reverse transcription real-time polymerase chain reaction (RT-qPCR) automated platforms.
The funds will be used to expand clinical performance data and finalize assay design. The company plans to start broad clinical validation studies for market approval in the second half of 2020. The financing round was led by VRD and supported by the Bavarian Growth Fund of Bayern Kapital GmbH and private investors.

Lophius says it recently achieved an important clinical development milestone for the proprietary detection assay, which compares active and latent TB patients with uninfected control subjects. The Lophius solution exceeded predefined performance goals, the company says.

In particular, the assay outperformed the benchmark interferon gamma release assay by correctly classifying more than 95% of patients with active TB as infected. In addition, sputum smear-negative active TB cases that were missed by conventional polymerase chain reaction (PCR) assays were correctly classified as infected. The results show the potential to complement direct pathogen detection by PCR, the company says.

“We are excited that these additional funds enable us to continue our program for establishing a new standard in TB diagnosis,” says Bernd Merkl, CEO of Lophius Biosciences. “The achieved high-performance level of our blood-based solution allows the early identification of TB in the diagnostic workflow, with the potential to significantly improve patient management and to save healthcare costs.”

Merkl says the company has “a solid basis” for reaching its goal of a breakthrough in differentiating between cases of latent TB and cases of active TB that require treatment.

For more information, visit Lophius Biosciences.