biomarker-based blood test that detects RNA signatures, allowing for the diagnosis of both pulmonary TB in non-sputum producers and extrapulmonary TB through blood samples. The test computes a score based on RNA signature gene expression levels, estimating disease severity rather than merely detecting the presence of Mtb, as pathogen-based molecular tests do.
· The score provided by CureDx helps clinicians classify patients as good-responders, intermediate-, or poor-responders to treatment. Intermediate or poor responders can promptly undergo treatment modification or further confirmatory testing for drug-resistant TB.
· The expression of RNA signature genes is also useful for confirming whether the treatment has worked and the TB patients are fully cured, making CureDx a reliable end-of-treatment tests do
· As per protocol, the response to 1st line TB treatment is measured at 8 weeks post-initiation. Poor responders then undergo DR-TB testing and treatment adjustment. Delayed identification of poor responders increases drug resistance, disease transmission, and patient side effects. There is a critical need to monitor treatment response, rapidly identify poor responders, halt ineffective therapies, curb drug-resistant TB spread, and improve outcomes.
· Treatment endpoint is often defined by national/global programme guidelines. However, a one-size-fits-all approach might not necessarily “cure” every patient. There is a need to assess, in a personalized manner, whether a person is fully cured at the end of treatment, or the treatment needs to continue/changed to 2nd line.
· Sputum handling also presents serious biosafety issues.
IMPACT
This easy-to-administer test, once developed, will be available at ~INR 1000 per test, which is 1/6th the cumulative cost of the multiple tests that need to be taken during the TB treatment course. The test itself takes ~ 12-24 hours turnaround time vs. current methods that take 4-6 weeks. Moreover, the technology is a platform solution and can also be used to detect Sepsis, extra pulmonary TB and Cancer. Healseq has completed product development and the test is being currently evaluated using TB patient samples from five tertiary hospitals in Karnataka.
“TB treatment is given for a long duration, typically lasting 6-9 months However, not all TB patients respond to the first line of treatment. It is therefore important to recognise the efficacy of the treatment as early as possible, so that the patient can be switched to second-line therapies. HealSeq’s innovation is aimed at designing an accurate molecular test that will track the patient’s response to the disease before and after the treatment and improve prognosis. India Health Fund’s support to HealSeq occurs at a very crucial time as we validate blood-based host biomarkers for TB. Since the India Health Fund support includes not just funding, but also efforts in hand holding, monitoring, mentoring, and integrating the company into the healthcare ecosystem, it will make a major difference to HealSeq’s work in TB.”
Dr. Nagasuma Chandra, Co-founder, HealSeq Precision Medicine Pvt. Ltd
Related Articles
