Breakthrough DNA test to identify all drug resistance mutations in tuberculosis
MedGenome Labs forays into infectious disease testing with a unique offering of genetic tests
MedGenome Labs- leader in clinical data driven genetic diagnostics and drug discovery research in India, has developed ‘SPIT SEQ’, the first Whole Genome Sequencing based test that can provide a detailed analysis of every single mutation present in any tuberculosis bacteria causing drug resistance-directly from the sputum. This break-through will enable a doctor to quickly and accurately prescribe the most effective drug to a tuberculosis patient without a trial and error process, followed currently that takes a month.
India has the largest number of multi drug resistant (MDR-TB) TB cases. SPIT SEQ can be a boon for TB patients, clinicians and healthcare agencies to achieve India’s Sustainable Development Goal (SDG) of elimination TB by 2025. The test is based on whole genome sequencing of mycobacterium tuberculosis (MTB), the TB causing bacteria, to assess the mutations in bacteria’s genome and allows a clinician to determine which drugs will work for a patient.
This test has been validated with over 100 samples where it recorded with 100% sensitivity and 98.04 % specificity when compared with Line Probe Assay (LPA). 50 out of those samples were in association with P.D. Hinduja Hospital and Medical Research Centre, Mumbai. A manuscript is under review for publication. Typically, the process of analyzing the drug resistance is very long which delays treatment for MDR-TB patient. Here as well, the current expertise allows testing resistance only on 4 drugs hence the patient had to wait until testing on all possible drug concluded. In such a situation, where long turn-around diagnosis time, repeated testing led to multiple changes in the course of treatment along the way.
“Direct Whole Genome Sequencing reveals information on drug resistance mutations for all anti TB drugs in a matter of 10 days. Soon, this technology will help in optimizing the precise management of an MDR-TB patient,” said Dr Camilla Rodriques, P D Hinduja Hospital and Medical Research Centre, Mumbai.
According to WHO report, there were 2.7 million TB cases (incidence + relapse) in 2017 and India accounted for 27% of global TB deaths. Second most appalling insight is that globally, 3.5% of the new TB cases and 18% of previously treated patients suffered from relapse due to the immunity developed by tuberculosis bacteria.
The conventional tests available in the country equip us to identify resistance in a limited fashion. Mtb (Mycobacterium tuberculosis) is slow-growing, taking 6-8 weeks for culture growth, thereby delaying not only TB diagnosis but also the drug resistance testing. SPIT SEQ is a culture-free WGS (whole genome sequencing) method for identification of Mtb and prediction of drug resistance with a turnaround time of 10 working days. Another strength of WGS over rapid molecular tests (LPA) is in the resolution of non-interpretable (NI) results that occur when a locus of interest has neither the wild type nor the specific mutation of interest present. A total of 12 such mutations were detected by our SPIT SEQ WGS test which was missed by LPA.
“SPIT SEQ is a massive breakthrough that can help millions. This particular test not only brings accurate results but also saves a lot of time where TB treatment is concerned. In lines with India’s objective to counter TB effectively and quickly, we aim to benefit the last person living with TB today,” said Dr VL Ramprasad, COO, MedGenome Labs.
With the flagship test for tuberculosis ‘SPIT SEQ’, MedGenome Labs is entering into infectious disease genetics and collaborating with XCyton Diagnostics, Bangalore. This collaboration will boost integration of various genetic tests under infectious diseases available with XCyton through the network established by MedGenome Labs. These tests include eye infections, brain and blood infections. MedGenome will be the exclusive sales partner for all XCyton tests in India. “Infectious diseases remain a major challenge, leading to significant healthcare expenditure, for India. This partnership can act as a synergy in India’s quest against infectious diseases. MedGenome’s reach across India’s geography will prove to be pivotal in the success of integrating genetic testing in healthcare service segment while we at XCyton continue to be focused on research and development of current as well as new tests,” said Dr B V Ravikumar, Founder and Managing Director, XCyton Diagnostics Ltd.