Sunday November 17, 2019

Genomic Sequencing-based Test Detect Resistant Mutation In Tuberculosis

Indian firm develops a test to detect drug-resistant TB mutation

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Tuberculosis
Doctors can use direct whole genome sequencing to get information on drug resistance mutations in TB. Pixabay

Genetic diagnostic and drug discovery research firm MedGeneome Labs on Thursday claimed to have developed the first whole genomic sequencing-based test to detect drug-resistant mutation in tuberculosis (TB) bacteria.

“The breakthrough DNA test will enable a doctor to correctly prescribe the most effective drug to a TB patient without a time-consuming trial and error process,” said the city-based clinical data-driven Labs.

Announcing its foray into infectious disease testing in TB, central nervous system (CNS), systemic and eye infections, the company said India had the largest number of multi-drug resistant (MDR) TB cases.

Tuberculosis detection
A breakthrough DNA test will enable doctors to correctly prescribe the most effective medicine to a TB patient. Pixabay

“India has the largest number of MDR-TB cases. Our spit sequence can be a boon for TB patients, clinicians and healthcare agencies to achieve the sustainable development goal of eliminating TB by 2025,” Labs Chief Operating Officer V.L. Ramprasad told reporters here.

“The test is based on the 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 drug will work for a patient,” he said.

Mumbai-based P.D. Hinduja Hospital and Medical Research Centre head Camilla Rodrigues said the test was validated with 100 samples recording 100 per cent sensitivity and 98.04 per cent specificity compared with line probe assay technology.

tuberculosis
India had the largest number of multi-drug resistant (MDR) TB cases. Pixabay

“Of the 100 samples, 50 were tested in our hospital. The findings in the manuscript are under review for publication,” Rodrigues said on the occasion.

Noting that the process of analyzing the drug resistance was long, which is delaying early treatment for MDR-TB patient, Rodrigues said the current expertise allowed testing resistance only on 4 drugs, which makes the patient wait until testing on all possible drugs concluded.

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“Direct whole genome sequencing reveals information on drug resistance mutations for all anti-TB drugs in 10 days. Our testing will help to optimise the management of an MDR-TB patient”, she added. (IANS)

Next Story

New Tuberculosis Treatment for 150 Countries Including India and South Africa to Cost $1,040

BPaL is an oral treatment which promises a shorter, more convenient option to existing TB treatment options, which use a cocktail of antibiotic drugs

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Tuberculosis, Treatment, Countries
A tuberculosis patient receives treatment at the TB Hospital in Gauhati, India, March 24, 2012. VOA

A newly approved three-drug treatment for tuberculosis will be available in 150 countries including India and South Africa, priced at $1,040 for a complete regimen, more than twice the cost proposed in the past by advocacy groups for other treatments.

The United Nations-backed Stop TB Partnership said on Monday that BPaL would be obtainable in eligible countries through the Global Drug Facility (GDF), a global provider of TB medicines created in 2001 to negotiate lower prices for treatments.

Tuberculosis was responsible for 1.5 million deaths in 2018.

BPaL is an oral treatment which promises a shorter, more convenient option to existing TB treatment options, which use a cocktail of antibiotic drugs over a period of up to two years.

Tuberculosis, Treatment, Countries
The United Nations-backed Stop TB Partnership said on Monday that BPaL would be obtainable in eligible countries through the Global Drug Facility (GDF), a global provider. Pixabay

The new cocktail, which will treat extensively drug-resistant strains of the illness, consists of drug developer TB Alliance’s newly-approved medicine pretomanid, in combination with linezolid and Johnson & Johnson’s bedaquiline.

Pretomanid, which will be available at $364 per treatment course, is only the third new medicine for drug-resistant tuberculosis to be approved in about 40 years, after J&J’s bedaquiline and Otsuka Pharmaceutical Co Ltd’s delamanid.

Criticism

Advocacy groups have long criticized the cost for bedaquiline and delamanid. Not-for-profit Medecins Sans Frontieres (MSF) has waged a running battle in public with J&J over its $400 price tag for a six-month course for bedaquiline.

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MSF has argued that bedaquiline could be produced and sold at a profit for 25 cents per day, and that the price of treatments for drug-resistant TB should be no higher than $500 for a complete treatment course.

Leena Menghaney, the South-Asia head for MSF’s Access Campaign, said it was a cause of concern that pretomanid was priced just below the price of bedaquiline.

But Stop TB Partnership says costs of other regimens for extremely drug-resistant TB range from $2,000 to $8,000 — for courses of at least 20 months.

Drugmakers

Tuberculosis, Treatment, Countries
Tuberculosis was responsible for 1.5 million deaths in 2018. Pixabay

TB Alliance in April granted a license to U.S. drugmaker Mylan NV to manufacture and sell pretomanid as part of certain regimens in high-income markets, as well as a non-exclusive license for low-income and middle-income countries, where most tuberculosis cases occur.

Stop TB Partnership said it would start supplying the regimen following World Health Organization’s guidance on using the drug. Mylan, however, said it will also sell the drug directly to countries.

Prices in low-income countries would be in-line with the price offered through GDF, but would be decided on a case by case basis where the drug is not supplied through GDF, it said.

The drug will be available in bottles of 26 tablets, with a six-month treatment requiring seven bottles.

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India-based Macleods Pharmaceuticals Ltd has also been granted a non-exclusive license to make pretomanid as part of the BPaL regimen, TB Alliance said Monday.

The maker of generic drugs will market the treatment in about 140 countries with high tuberculosis rates. (VOA)