Molecular Diagnostics Innovators Illumina, QIAGEN, Guardant Health, and 10x Genomics Showcase Strategic Advances at J.P. Morgan Healthcare Conference 2019

Once-in-a-lifetime encounter. In January 2019, the J.P. Morgan Healthcare Conference was held as scheduled in San Francisco. At this event, dubbed the “Super Bowl of Biopharma,” massive biopharmaceutical technology deals are often struck amidst clinking glasses and a series of handshakes and conversations.

Selected News Highlights from the 37th Annual J.P. Morgan Healthcare Conference

Following yesterday’s roundup of pharmaceutical giants, VCBeat (WeChat Official Account: vcbeat) will now present a curated summary of insights shared by executives from molecular diagnostics companies, including Qiagen, Illumina, Guardant Health, and 10x Genomics.

On the first day of JPM, Qiagen launched multiple new products and announced its acquisition plans. The company stated that it would maintain its position as one of the most diversified life science research and molecular diagnostics companies.

Peer Schatz, CEO of QIAGEN, stated that the company plans to establish a digital diagnostics system based on the core digital PCR technology acquired from Formulatrix. It will also develop a handheld tuberculosis detection device, QuantiFERON-TB Gold Plus, and promote its use in resource-limited regions worldwide for tuberculosis testing.

The company disclosed that it has acquired N-of-One, augmenting its bioinformatics platform to provide decision support for molecular oncology diagnostics. The company also launched a new next-generation laboratory automation sample processing system, the QiaCube Connect.

For a long time, QIAGEN has been the leader in the real-time PCR market, while digital PCR is an area that the company has not ventured into. This situation will change with QIAGEN's acquisition of Formulatrix.

Formulatrix, a Boston-based company, has developed Constellation, a low-cost, plate-based digital PCR system. This system offers a middle ground between high-priced droplet digital PCR systems and traditional plate-based real-time PCR.

QIAGEN has not yet disclosed the financial details of the acquisition, stating only that the transaction is expected to close in mid-2019. The company is currently awaiting regulatory approval, with the relevant products anticipated to launch in 2020.

Schatz stated that Qiagen has been monitoring the development trends of digital PCR in recent years, and they consider it to be the most attractive and high-growth segment within the life sciences field. He noted that while the market size for digital PCR remains relatively small, estimated at between $150 million and $250 million, its growth trajectory is evident, currently accounting for approximately 10% of the overall market. In contrast, the real-time PCR market is valued at around $2 billion.

QIAGEN began collaborating with Formulatrix several years ago. Schatz stated that Formulatrix’s microtiter plates are fully compatible with QIAGEN’s PCR products, enabling a smoother sample integration workflow.

He pointed out that QIAGEN hopes to reduce the turnaround time of its digital PCR platform workflow from the current 300 minutes to 90 minutes. Although the product was initially intended for research use only, digital PCR technology is gradually penetrating the molecular diagnostics market, and QIAGEN will adapt to this trend.

Another R&D initiative is a handheld tuberculosis detection device; Qiagen is collaborating with the Australian company Ellume, which will receive approximately $15 million in investment from Qiagen.

Currently, the tuberculosis (TB) testing market accounts for only about 20% of the overall market, yet it remains critically important. To participate in national screening programs, companies must offer diversified solutions that not only meet the needs of central laboratories but also address how TB testing can be conducted in resource-limited settings. Schatz noted that approximately 85% of TB cases occur in resource-limited areas, with substantial evidence indicating that TB control is most challenging in these regions.

“Now, leveraging QuantiFERON’s leading technology, we are launching a handheld, battery-powered device that will represent a true breakthrough in the tuberculosis testing market.”

The company noted that, leveraging QuantiFERON technology, the device can complete testing in a single run. This device detects tuberculosis using blood samples. While conventional tests typically require 16–24 hours of preparation, the results are displayed on a real-time integrated monitor equipped with battery power and USB connectivity, operating independently of a computer. If needed, the generated data can be stored and retrieved later.

QIAGEN disclosed that the product is expected to be launched in 2020.

Qiagen also launched the next-generation laboratory automated sample preparation system, QIAcube Connect, and acquired the bioinformatics company N-of-One.

QiaCube Connect is the next-generation product of QIAGEN’s existing laboratory sample preparation system, QiaCube, which currently serves approximately 8,000 laboratories worldwide. The new generation simplifies workflows and enhances operational efficiency. Specifically, the system automates the lysis, binding, washing, and elution steps.

Importantly, the new system can be fully integrated with the new digital flat-panel PCR system and is compatible with more than 80 of Qiagen’s existing kits and over 3,000 protocols. Schatz revealed that early versions of the new system have already been trialed by some of the company’s customers, and the company is eagerly anticipating the onboarding of new clients.

Qiagen aims to augment its literature-based interpretations with substantial real-world evidence and further enhance its software and automated knowledge base capabilities through the acquisition of N-of-One.

“With $70 million in transactions secured in the bioinformatics sector, Qiagen has solidified its position as the industry leader.” The addition of N-of-One will enable Qiagen to further expand its target customer base, including insurance providers and pharmaceutical companies.

In early 2018, Roche announced the acquisition of Flatiron Health, aiming to augment its oncology drug development efforts with real-world evidence. This may signal a growing trend toward integrating real-world data with knowledge-base evidence.

Schatz said, “In the long run, the key to future differentiated competition may lie not in technology, but in informatics.”

Illumina announced that it would launch the NovaSeq next-generation chips in the first quarter of 2019 and upgrade the iSeq kit, but the company has not yet released new sequencers.

In addition, Illumina plans to continue expanding its presence in the clinical market. Francis DeSouza, the company’s president, stated that Illumina has already launched the research-use-only version of the TruSight Oncology 500 assay system and intends to release a clinical version. An expanded panel for the VeriSeq NIPT assay is also scheduled for launch in the first half of 2019.

In the first quarter, Illumina will also launch iSeq series kits to enable 250-base-pair paired-end reads, along with a 1.7-fold increase in output and a 20% price reduction.

DeSouza also mentioned that the company’s revenue in the fourth quarter of 2018 rose by 11% year over year, to approximately $865 million. Full-year revenue increased by 21% year over year, to approximately $3.3 billion.

In the future, Illumina will continue to expand its influence in the clinical sector, pursue regulatory approvals for its clinical instruments, and develop clinical analysis products. DeSouza revealed that after the MiSeqDx received approval from China’s National Medical Products Administration in August 2018, Illumina initiated collaborations with KingMed Diagnostics, a tumor diagnostics company, and a Chinese genetic disease company.

DeSouza also stated that the company has launched the TruSight Oncology 500 assay for research and pharmaceutical companies. The pan-cancer DNA and RNA panel includes testing for tumor mutational burden and microsatellite instability, biomarkers increasingly recognized as important indicators of response to immunotherapy. The current version of the Illumina TSO 500 assay is designed for formalin-fixed, paraffin-embedded samples. However, DeSouza noted that Illumina is collaborating with pharmaceutical partners to develop a version compatible with blood samples.

Furthermore, Illumina announced that the research-use-only version of its TruSight Oncology 500 assay has been launched, targeting research institutions and pharmaceutical companies. This pan-cancer DNA and RNA panel includes detection of tumor mutational burden and microsatellite instability, biomarkers whose significance in tumor immune response is increasingly recognized.

Another direction for Illumina in the clinical field is NIPT. The company plans to launch the second version of the VeriSeq NIPT test in the first half of 2019. The new version will expand from aneuploidy assessment to whole-genome analysis.

DeSouza mentioned that Illumina will collaborate with the Mayo Clinic to develop whole-genome sequencing products. This product can rapidly identify disease-causing mutations through whole-genome sequencing and provide patients with precision medications. Currently, the company has not disclosed further details. DeSouza also addressed the acquisition of the gene sequencing company Pacific Biosciences, which is expected to close in mid-2019.

Illumina’s full-year 2018 revenue reached $3.3 billion, a performance primarily driven by growth in its sequencing business. The company’s sequencing consumables revenue increased by 23% in 2018, while sequencing instrument revenue grew by 10%. Other businesses also performed strongly, with a 22% increase.

In the fourth quarter of 2018, Illumina’s revenue reached $865 million, an 11% increase from $778 million in the fourth quarter of 2017. DeSouza stated that sales of sequencing systems hit a record high in the fourth quarter, with NovaSeq system shipments also reaching an all-time high.

The company expects its 2019 revenue to grow by 13% to 14%, reaching $3.76 billion to $3.8 billion, with GAAP earnings per share (EPS) projected at $6.07 to $6.17 and non-GAAP EPS at $6.50 to $6.60.

Earlier, Guardant Health launched a new liquid biopsy test designed to detect early-stage tumors through blood analysis. The test panel encompasses both genomics and epigenetics. Guardant Health’s “Moonshot” initiative is primarily research-oriented, focusing on DNA screening in tumor blood tests, selection of adjuvant therapies, assessment of recurrence risk during post-treatment follow-up, and monitoring of treatment response.

Daniel Simon, Senior Vice President of Biopharma Business Development at Guardant Health, stated at the J.P. Morgan Conference: “An increasing number of biopharmaceutical partners are beginning to incorporate clinical testing into their drug development considerations.”

The “Moonshot Project” collected samples from more than 80,000 cancer patients, who were tested using the company’s Guardant360 product or other whole-genome sequencing data.

This project aims to overcome the challenges currently encountered in the early detection of cancer and to break through the bottlenecks of the Guardant360 and GuardantOMNI testing products.

Recently, 10X Genomics announced a new round of financing during the JPM Healthcare Conference. The $35 million Series D round was led by Meritech Capital, with participation from Fidelity, Wells Fargo, Paladin Capital, and SoftBank.

10x Genomics is a leader in the gene sequencing industry, providing accurate and comprehensive gene sequencing services to research institutions worldwide. Founded in 2012, 10x Genomics has emerged as a highly regarded dark horse in the field of gene sequencing, attracting significant investor enthusiasm and raising a total of $243 million in funding within just a few years.

Over the past six months, 10X Genomics has completed two major corporate acquisitions: Epinomics, a company focused on epigenetics, and Spatial Transcriptomics, a developer of two-dimensional gene expression technology. These acquisitions have further solidified 10X Genomics’ leadership position in the gene sequencing industry.

From 2015 to 2017, 10X Genomics’ revenue grew twentyfold, reflecting strong market demand for its gene sequencing products.

Dr. Serge Saxonov, CEO of 10X Genomics, stated, “Over the past year, 10X Genomics has continued to grow and expand, launching new products and welcoming two outstanding companies into our fold. We aim to maintain this growth trajectory, scaling up tenfold from our current base to become a company that impacts the lives of billions of people worldwide.”