Instant Report

Date: 22-Apr-2021

Cepheid Seeks Approvals To Manufacture Point-of-care Covid-19 RT-PCR Diagnostic Test In India

US firm Cepheid is in the process of seeking approvals to manufacture point-of-care Covid-19 RT-PCR diagnostic cartridges that will be made in India.

"From India's perspective, and manufacturing perspective for Covid, we are working on getting certain approvals, and then we will be able to provide make In India Covid project," stated David H Persing, executive vice president, chief medical & technology officer.

The worldwide demand for this technology is extremely high, and Cepheid runs 24/7 to produce as many Covid test cartridges as possible. Last year, we had about 28 million Covid tests and what we call 4Plex tests or FluVid tests containing Covid, the company stated.

The company is adding a new manufacturing facility in Bengaluru to empower the Indian healthcare system to become self-reliant, add better TB diagnostics and create additional jobs.

Persing added, "I think the commitment of Cepheid for India shows by the fact that we are expanding in India. We already have a plant in Chennai that's manufacturing TB tests right now, and the intent is evident that we want better access to patients.

The company launched GeneXpert Infinity and Omni systems for TB testing in India. The GeneXpert Infinity is a laboratory-based system based in a central laboratory with high throughput capabilities.

The company stated that Omni would bring the technology to regions that are furthest away from central laboratories, so it gets the technology to the points of needs, to the end of care.  Omni can be run in a microscopy center, for instance, where a classical way of making a TB diagnosis is to create a sputum smear and look for TB organisms on the smear. This is not a very sensitive method. It doesn't detect drug resistance, so we think that where Omni could go is into these places where TB patients are being seen in microscopy centers.

"This technology is designed to run on a sample in, answer out basis, so it runs samples as they become available. In terms of the number of samples that can be run at one time, on the Infinity system, we can run over 2,000 samples per day of the Covid test because of the high throughput format with 80 modules running simultaneously. So for the Covid test, over 2,000 samples per day. For the TB test, the TB test takes about an hour for a negative result and about 70 minutes, 75 minutes for a positive test," stated Persing.

The company stated that the MTB/RIF test for diagnosing TB is designed to detect active tuberculosis. It is also intended to go beyond just testing for one drug resistance.

"We have followed up this test with a multi-drug resistant XDR TB test, which goes beyond rifampin resistance testing as a surrogate for drug resistance and allows us to look at a low level, high-level INH resistance and resistance to other drugs as well. So as we see emerging resistance and multi-drug resistance, and even extreme drug resistance, this technology will enable us to get a much more comprehensive picture of drug resistance inactive tuberculosis cases. So, we continue to invest in the tuberculosis portfolio, building new products," the company stated.

Cepheid is a leading molecular diagnostics company, dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases.