Fluidigm's FDA-EUA Authorized Saliva-based SARS-CoV-2 RT-PCR Assay - Now for use in India

It’s been a year now since the first few human cases of COVID-19 infection were reported amidst the busy wholesale food market of China’s Wuhan city (1). The disease caused by SARS-CoV-2 virus, thought to have its origin in Bats, soon spread to cause worldwide outbreaks & escalated to a global pandemic. The latest statistics indicate 46.5 Million cases reported to date worldwide with the global mortality rate around 2.5% and India ranking second at 8.23M cases till date (2).

COVID-19 has brought with it the need for SARS-CoV-2 tracking, surveillance & diagnosis. Countries that adopted testing strategies early on were able to test, track & isolate individuals that showed disease symptoms & hence were better able to contain the disease spread. While antibody testing was initially taken up for screening, it was soon evident that Real-time PCR alone had the power for accurate diagnosis, making it the gold-standard confirmatory test for SARS-CoV2. At the start, the sample collection process for RT-PCR testing involved painful & inconvenient nasopharyngeal/oropharyngeal swab collection. This requires skilled technicians, who would additionally run the risk of exposure. This has even led to a couple of neo-natal deaths in India, due to inappropriate sample collection (3).

More recently, saliva-based testing methods are gaining popularity after studies suggested saliva specimens and nasopharyngeal swab specimens have similar sensitivity in the detection of SARS-CoV-2 (4).

Fluidigm’s Advanta Dx SARS-COV-2 RT-PCR kit is a saliva based diagnostic test (5). This kit facilitates SARS-CoV-2 detection from saliva samples easing the sample collection process & eliminating the need for Viral RNA extraction process. The kit is compatible with Fluidigm’s high-throughput Biomark HD platform. Fluidigm claims that with certain configurations, the Biomark HD system can run a maximum of 6000 samples & controls per day. Modular workflow supports concurrent parallel runs to achieve high throughput (6).

This FDA-EUA approved kit has also now received DCGI-CDSCO license for use in India by ICMR approved testing labs as per their guidelines. This test kit from Fluidigm is sold & marketed by Premas Lifesciences Pvt Ltd, New Delhi in India.

With schools, colleges, corporate offices opening up, saliva-based testing using Biomark HD can add great value for faster, non-invasive & safer testing. Several universities in the US have already started utilizing Fluidigm’s saliva-based assays & Biomark HD for testing their students (7). Fluidigm is also a recipient of a prestigious NIH-RADx grant. The RADx initiative fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2. Fluidigm’s assay was utilized in labs supporting the US Government’s surge testing efforts for ramping up testing (8).

It is noteworthy that even before the launch of Fluidigm’s saliva kit, many testing labs across the globe had already started deploying their own in-house workflows for SARS-CoV-2 testing using the Fluidigm Biomark HD platform. Oklahoma Medical Research Foundation (OMRF), Lab24Inc, Ohio consultative genomics, Gnome Dx, Bioexpedia, Denmark & iGLS, Spain are some of the notable examples on this list.

With Dengue, Malaria, Influenza and other respiratory diseases also being prevalent currently, additional panels for screening can be added with ease without much change in the cost per sample. As some of these other conditions also have overlapping symptoms with COVID-19, such panels & technologies would help making testing more affordable & relevant to current times.

Mr. Praveen Gupta, MD, Premas Lifesciences says, “Fluidigm’s much-needed non-invasive saliva-based test comes at a critical time in the pandemic, and we are pleased to be able to facilitate availability of the Advanta assay in India.”

Indias reported coronavirus cases have surpassed 9 million, a total so far exceeded only by the United States. In a recent Fluidigm announcement, President & CEO Chris Linthwaite said “Since announcing our Emergency Use Authorization in the United States for saliva-based PCR testing, we have seen growing interest in our technology. License to market our Advanta Dx SARS-CoV-2 RT-PCR Assay in the world’s second-most populous nation will enable an effective and scalable way to get non-invasive saliva-based testing across India as a possible second wave of infections approaches.“

“We are now in discussions with potential customers, which include private testing labs as well as academic institutions and government medical centres. We are honored for the opportunity to advance the availability of non-invasive saliva-based COVID-19 testing in India at this critical time.”

References