India Health Fund Supports HealSeq: A Biomarker-Based Test That Reduces Time For Diagnosis,Ttreatment Of DR - TB To 2 Weeks

•   The Innovation is an affordable & easy to use biomarker-based blood test that can guide in early diagnosis and treatment of Drug Resistant Tuberculosis (DR TB)

•   This test is aimed at significantly speeding the treatment and diagnosis of DR TB by reducing the time to diagnose drug resistance from 4 months to 2 weeks.

Health Fund (IHF), a collaborative initiative of Tata Trusts and The Global Fund to fight AIDS, Tuberculosis and Malaria today announced its support for HealSeq’s innovation – a biomarker-based blood test that is expected to accurately determine a patient’s response to TB treatment in 2 weeks of its initiation. This innovation has the potential to guide clinical decision of shifting to second line therapies, by enabling early diagnosis and treatment of Drug Resistant TB (DR TB). Standard TB treatment (first line treatment) is initially given to all TB patients. However, when the TB bacteria becomes resistant to the standard treatment, second line therapies are administered which include drugs used for treating DR-TB

Current molecular methods detect DR TB before treatment initiation by identifying known drug resistant mutations in the pathogen. There are however many other causes for DR TB, which can be missed. The efficacy of the treatment in all TB cases is realised about 4 months post treatment initiation, which results in late diagnoses of DR TB. Late diagnosis is one of the key reasons for the increase in incidence of DR TB disease. IHF’s support to HealSeq’s innovation is aimed at developing and validating an accurate, low cost, easy to administer test that can identify Drug Resistant TB early and, guide fast clinical decision to shift to second line therapies.

HealSeq’s innovation is a host bio-marker-based blood test, which can detect RNA signatures from TB patients as early as 2 weeks after treatment initiation. The abundance of these RNA signature genes can help physicians to classify patients as good-responders, intermediate or poor-responders to the treatment. Intermediate or poor responders, diagnosed as DR TB patients, can be immediately shifted to second line therapies. The test is at 1/6th the cumulative cost of the multiple tests that need to be taken during the TB treatment course and can be administered using a simple RT PCR kit. This is a breakthrough in the diagnosis and treatment of DR TB as it has the potential to significantly speed up diagnosis and treatment and, curtail the spread of the disease.

Tuberculosis (TB) is a communicable disease and one of the leading causes of death, worldwide. As per India TB Report 2021, Central TB Division, Ministry of Health and Family Welfare, the disease kills more than 0.4 million people every year in India alone and we carry the burden of a quarter of the world's cases. In the last two years, about 1.15 lakh people were detected with Drug Resistant TB (DR TB) with fatalities accounting for about 20% of the detected patients. Drug-resistant TB occurs when the bacteria become resistant to the first line standard treatment given to all TB patients. These ‘low responders’ to standard first line TB treatment have a high chance of severe consequences, like organ failure, high probability of catching multiple drug resistance and, even, death. It also leads to increased risk of community transmission of DR TB.

Dr. Nagasuma Chandra, Co-founder HealSeq Precision Medicine Pvt. Ltd., says, “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.

Mr. Madhav Joshi, Chief Executive Officer, India Health Fund, says, “With the large TB burden and challenge that India faces, the current medicines, tests, vaccines need to be updated with truly modern tools. TB patients need a short, simple, well-tolerated and affordable treatment that will help improve health outcomes. India Health Fund is pleased to support HealSeq which is expected to be a big step forward in the early diagnosis and treatment of DR-TB. We as a country can end the TB emergency, but with a durable commitment to higher investments in scientific research and development. Increased focus and investment in the development of new tools will help patients, save lives and curb community spread of the disease. IHF remains invested in its mission of helping reduce preventable deaths from communicable diseases and other public health risks. We do this by de-risking the development of promising technology and science-led solutions that have the potential to make a significant difference in the diagnosis, treatment and prevention of communicable disease”