DBT releases SOP for engaging private labs for genome sequencing of Covid-19

Mumbai, September 25, 2021:

The Department of Biotechnology (DBT) has released a standard operating procedure (SOP) for involvement of private laboratories for genome sequencing of Covid-19 virus which will help detect new coronavirus variants as well as significantly enhance genomic surveillance in the country.

Selected private laboratories will join the Indian SARS CoV-2 Genomic Consortia (Insacog), a network of 28 government laboratories established for genomic surveillance in the country in January.

So far, Insacog genome sequencing laboratories (IGSLs) have carried out genome sequencing of 60,000 positive cases from different states of India. The Delta and Delta Plus (B 1.617.2.1 (AY.1) variants were also identified on whole-genome sequencing analysis conducted in the Insacog laboratories.

In a bid to increase sequencing efforts further and conduct sequencing about 80,000 samples in a month for identification of variants of concern (VoC) and variants of interest (VoI) in the Indian samples, so as to advice the policy makers for effective management of Covid-19, DBT decided to involve private laboratories.

At present, the variants of concern have been found in 174 districts in 35 states in India.

Accordingly, the department recently held a meeting with some prominent private players viz. New Delhi-based Mahajan Imaging Private Limited, Premas Life Sciences, Bengaluru-based Strands Life sciences and Genotypic Technology Private Limited, Gurgaon-based NMC genetics India Private Limited and Hyderabad-based Mapmygenome India Limited.

A standard operating procedure (SOP) was framed for the participants in genomic sequencing.

As per SOPs, Insacog may identify the potential laboratories through interest expressed by private sequencing laboratories which may be accredited for their sequencing capacities and infrastructure based on their capabilities, infrastructure and experience.

The interested private laboratories need to provide certain information to Insacog including type of sequencing platform that is operational, number of viral genome sequences that is being proposed to carry out per week/per month, number of trained laboratory personnel available for sequencing/sequence analysis, approximate turnaround time (TAT) for reporting sequencing information and ability to provide both FASTQ and consensus FASTA files for each sample sequenced.

They also need to inform Insacog about availability of biosafety level-2 facility in case of requirement for RNA isolation from VTMs and previous experience of whole genome sequencing service provided to any public and private sector laboratories and the type of genome sequencing carried out.

Once this information is received, the co-convenors of Insacog will examine the details and place a proposal for consideration, review and recommendations of the co-chairs of Insacog to identify potential private sector laboratories for their suitability for genome sequencing of SARS-CoV-2.

The decision of the Insacog Scientific and Clinical Advisory Group (SCAG) co-chairs will be communicated to the DBT for further consideration for accrediting their sequencing capacities. The details of the accredited private laboratories will be communicated to all Insacog-IGSLs and also placed in DBT Insacog portal.

The private laboratories will be required to sign an agreement with the IGSLs specifying the terms and conditions for the contract. Upon signing the agreement, the IGSLs will provide the isolated RNA to the private laboratories for construction of c-DNA libraries and sequencing. These samples will be coded and no information on the patient IDs and other details will be provided to the private laboratories, stated the SOPs.

The private laboratories will provide sequence information as FASTQ and Consensus FASTA files to the IGSLs for submission to the national portal. These labs will be required to keep the information confidential and preserve the RNA samples for a specific period to be decided by IGSLs in consultation with Insacog-SCAG. PharmaNewz