BALTIMORE – BGI affiliate MGI Americas said on Monday that it will make its CoolMPS sequencing chemistry and DNBSeq-G400 sequencer commercially available in the US starting Aug. 29, the day a certain Illumina patent is set to expire.
The announcement, made right before this week’s Advances in Genome Biology and Technology (AGBT) meeting, signifies MGI’s ambition to take another stab at the US next-generation sequencing market, after its first attempt in 2019 was thwarted by Illumina’s patent litigation.
However, with new players such as Element Biosciences, Ultima Genomics, Singular Genomics, and Omniome (now part of Pacific Biosciences) recently emerging, MGI will not return to the same market it was forced to leave behind two years ago, and it remains to be seen how the Chinese sequencing tech firm will fare this time around.
According to MGI, the model for the August release will be the DNBSeq-G400C, a version of the DNBSeq-G400 sequencer that is based on the firm’s newer, antibody-based sequencing chemistry, CoolMPS, but the company stressed that it will not accept any orders before Aug. 29.
Additionally, sequencing reagent kits for various types of read and read lengths — SE50, SE100, PE100, and PE150 — will become available in the US over the course of several months, starting in September.
MGI first revealed its intent to launch its sequencing technology in the US in 2019, the same year the IP litigation between BGI and Illumina began to unfold.
In June 2019, Illumina filed the first lawsuit against BGI in the US, alleging that the Chinese company’s sequencing technology infringed its own sequencing-by-synthesis chemistry, specifically US Patent Nos. 7,566,537 and 9,410,200.
BGI countersued months later. The court narrowed that suit but allowed BGI's allegations of induced infringement to proceed. Meanwhile, BGI’s US affiliate, Complete Genomics, also sued Illumina, claiming the latter infringed its two-color sequencing technology.
In February 2020, shortly after Illumina asked a US federal court for a preliminary injunction against BGI for patent infringement, Illumina filed another lawsuit, claiming BGI's new CoolMPS chemistry also infringed Illumina’s IP, in particular US Patent Nos. 7,771,973; 7,541,444; and 10,480,025.
In June 2020, Judge William Orrick of the US District Court for the Northern District of California granted Illumina a preliminary injunction, barring BGI and its subsidiaries, including MGI, from distributing and promoting its sequencing platforms and chemistries in the US.
More than a year later, a California jury found BGI and its affiliates culpable of patent infringement and awarded Illumina $8 million in damages, while invalidating Illumina's US Patent No. 7,541,444 and claim one of US Patent No. 10,480,025.
Finally, this March, Orrick granted Illumina a permanent injunction against BGI and overturned the jury's decision to invalidate Illumina's US Patent No. 10,480,025. However, against Illumina's wishes, the injunction denied Illumina's request to overturn the jury's decision invalidating US Patent No. 7,541,444.
Without the '444 patent, which “contained the broadest of all the asserted claims and had the longest remaining life of the five asserted patents,” MGI may potentially begin selling products based on CoolMPS technology in the US as early as August 2022, MGI previously said in a statement responding to the jury verdict last year.
According to MGI, the ’973 patent, titled “Modified nucleotides,” is set to expire in August. Still, “the expiration of the patent doesn’t represent that we do not recognize its validity,” the company emphasized.
Illumina did not respond to questions about MGI’s planned August launch, or whether its remaining IP can no longer prevent MGI from selling its sequencing platforms in the US.
The DNBSeq-G400, a mid- to high-throughput model within the DNBSeq franchise, will be the first platform for sale. In an email, MGI said that the August release aims to target US customers with labs that run medium- to high-throughput sequencers, including academic research labs, core facilities, clinical labs, and clinical research labs.
While the company has yet to disclose list prices for the instrument and reagent kits in the US, it asserted that “the cost of ownership and running samples will be significantly lower than current comparable products on market.” MGI also said that, using 30X whole-genome sequencing as an example, the cost per sample of using the DNBSeq-G400 platform is around $500.
In terms of launch strategy, MGI said it will work with key opinion leaders and partners, as well as go directly to customer labs, which largely mirrors its earlier launch attempt. According to court documents filed by Illumina in February 2020 seeking a preliminary injunction against BGI, MGI planned to distribute the DNBSeq-G400 to up to five key opinion leaders in the US and intended to “offer the infringing products on a 'no-cost trial basis' to these potential customers.”
Although MGI did not disclose exactly how much market share it is targeting in the US, the firm said that with its “well-proven” DNBSeq technology, its top priority is to get its products into as many customers’ labs as possible, providing “a viable alternative” to them.
MGI touted four advantages of its sequencing technology, which it said can help it stand out from old and new competitors. For one, the company claims that DNBSeq, which enables true PCR-free sequencing, generates high data quality compared to other systems.
In a preprint posted by the company in 2020 to BioRxiv, MGI researchers generated 400-base single-end reads and 2x150-base paired-end reads using the CoolMPS chemistry, producing data for DNA nanoballs (DNBs) with fewer than 50 template copies. In addition, as MGI was drumming up for CoolMPS’s first US launch, the company’s early-access customers from Europe and Canada presented initial results on the technology’s data quality at the AGBT 2020 conference.
In addition, MGI said it has developed a full line of lab automation instruments and kits that go with DNBSeq sequencing instruments to enable sample-to-answer workflows. Specifically, it offers three main automation product lines, including the MGISTP series, which processes and tracks samples from tubes to 96-well plates; the MGISP series, multichannel automated liquid handlers that can perform sample extraction and library preparation; and the MGINE series, which enables automated nucleic acid extraction.
While the company’s sequencing platforms have been enjoined in the US, MGI said its lab automation instruments have been available in the US since 2019, and hundreds have been installed there over the last few years, along with thousands worldwide.
Moreover, MGI said it offers on-premise data analysis and storage products, as well as high data security. Its ZTRON series products provide on-premise data analysis and storage, with customers having 100 percent control of data in their own facilities, which few other competitors can achieve, according to the company.
Lastly, MGI highlighted its “fast and friendly” services. The company said it has built a strong customer support and service team in the US over the past three years and plans to hire additional personnel “to support an expected additional installed base of hundreds of sequencing instruments in the coming year.” However, it did not disclose a specific headcount for its customer support team or how many people it plans to bring on.
MGI has also installed close to 1,000 DNBSeq-G400 sequencers worldwide, outside of countries where it was restricted by Illumina’s IP, suggesting it has experience providing customer service and maintenance.
It remains to be seen how the US NGS community will react to MGI’s re-entrance, especially in light of the new sequencing platforms that recently emerged on the market.
Tomi Pastinen, director of Children's Mercy Genomic Medicine Center, said in an email that his lab has previously “observed similar performance” between MGI whole-genome sequencing data and Illumina PCR-free WGS data in terms of how well they replicated earlier exome data or correlated with independent microarray genotyping data. Pastinen’s team obtained MGI whole-genome sequencing data generated on DNBSeq-G400 through the McGill University Genome Center in Canada.
Looking at data from approximately 60 parent-child trios, Pastinen said his group also did not find significant differences between MGI sequencing and Illumina sequencing for structural variant detection, using the same sequence alignment and variant calling pipeline.
Pastinen’s lab also analyzed the reagent pricing, which suggested that MGI sequencing could be more cost effective than Illumina sequencing. However, he said that logistically, the price advantage was deemed not substantial enough to outsource samples from his lab, which is equipped with an Illumina NovaSeq, to an external facility.
He said that for him to consider adopting emerging NGS platforms for medical genetics applications, the data quality of the technology needs to match Illumina’s, in addition to other factors such as logistics, costs, and turnaround time. However, he said the “tipping point” could be if a new platform demonstrates improved performance for calling structural variations, an area that is still in need of improvement for short-read technologies.
Similarly, Chris Mason, a sequencing technology expert at Weill Cornell Medicine, said in an email that his lab “usually performs a rigorous assessment of new NGS tech” before adoption, and it plans to do the same with MGI’s CoolMPS. Still, he thinks a new market entry, which opens more options for customers, is good.
Moving forward, MGI said that beyond DNBSeq-G400, it plans to roll out its high-throughput DNBSeq T Series in the US market “definitely in 2023.” While the company did not disclose a concrete timeline for the release, it said it will announce future launch plans at the American Society of Human Genetics annual meeting in October.
Additionally, MGI said it will “take steps to launch its entire family of library preparation kits to enable whole-genome sequencing, whole-exome sequencing, RNA sequencing, metagenomics sequencing, single-cell sequencing, and more.”