This is a 2-hour presentation available online, my main reason to cover is the news on Roche’s Next Generation Sequencing plans.
In the description of the outline, the speaker mentioned:
“… Significant progress of the Nanopore Genia acquisition with the technology of the Stratos acquisition.”
Below are some of the highlights, ending with the details of the NGS efforts.
FMI will move from Pharma to Diagnostics, to better leverage the Next-Generation Sequencing technologies. There are many advantages in innovating in small companies, one of them is that your business unit is not constantly being re-organised.
The slide on the launches shows that Roche is nearing a 50/50% small molecule vs biopharma in the Pharmaceuticals segment. Therapeutic Antibodies continue to grow in adoption over a long history of about a century of pharma being almost exclusively small molecules.
Interesting that they only mention Next-Generation Sequencing within the ‘Molecular Lab’ part, which is ~18% of the Diagnostics sales. Put it another way, Roche makes a lot of money from their Cobas and Mass spectrometry line of products, what they call ‘Core Lab’.
First picture of the “Nanopore sequencer” in the center block, looks like a large desktop footprint machine: “high throughput highly flexible, under development”. Also highlighting the Mass Spec unveiling: it seems like Roche is as exited about their new Mass Spec product line as it is for their “in development” Nanopore sequencer.
A slide describing the new tests coming soon, including the Foundation Medicine products, which are based on short-read NGS (orange, part of FMI).
Palani Kumaresan steps up to give more details on Diagnostics solution.
A slide on the Oncology pipeline, with Next Generation as part of the yellow ‘Sequencing’ portfolio, including MRD on the top left for Monitoring. “We are really expanding into Screening and Monitoring”.
Focusing on Clinical Chemistry Core Lab, they are seeing a lot of growth in Cobas Pure and Cobas Pro in Serum Work Area (SWA).
Roche sees an opportunity in the Mass Spec market, as they see the current MS labs as messy as shown in the picture.
The Cobas Mass Spec is fully automated, all the steps from left to right. Proprietary Liquid Chromatography cartridges included. It will launch for ~300 tests and ~60 analytes over the next few years: Steroid, Vitamin D, … therapeutic monitoring, etc.
Launch starting end of this year (Q4 2024), wanting 25% market share by 2031.
Sequencing Update
Also given by Palani Kumaresan, shows how Roche currently excels in pre-steps and post-steps of sequencing, but doesn’t have their own sequencer yet, which they now intend to do with their Nanopore Sequencing solution.
Based on Xpandomer chemistry, or Sequencing by Expansion (SBX), that was originally developed by Stratos Genomics, which Roche acquired in 2020. The second component is the semiconductor part, which we detail in the Rumour Mill section of this post.
Very little detail on the official date when this Nanopore sequencer will be available, and what type of products will include.
Rumour mill
The rumour mill around the Roche NGS sequencing announcement confirmed the fact that it was going to take place during Roche Diagnostics Day 2024. Roche has been working on releasing something for the past 10 years, but still nothing until later on.
According to the best bets, it will be in 2025 or later, but not during 2024.
There are also rumours that there is something suspicious with the picture they showed of their 8M microwells chip. The semiconductor elements of this product come from Roche’s acquisition of Genia in 2014. DNA molecules are first enzymatically converted into a larger surrogate molecule, called an Xpandomer, that contains reporter molecules representing the DNA based and generating a strong signal. The Xpandomer, which is more than 50 times longer than the original DNA fragment, then passes through a biological nanopore, with a detector to read out the signal, which is translated back into the DNA sequence.
According to the rumours out there, the technology could reach 1,000bp if optimised, but it will be more of a “short-read” sequencer at launch. Depending on the amount of sequencing per run, this would be more comparable to an Illumina MiSeq run rather than an Oxford Nanopore MinION run.