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JP Morgan Healthcare, Day One: 10x Genomics, Myriad, Bruker, Konica Minolta, Geisinger

SAN FRANCISCO (GenomeWeb) - The 37th annual JP Morgan Healthcare Conference kicked off here on Monday with several life science tools and molecular diagnostics companies presenting before thousands of investors. Below are brief reports on the presentations and breakout sessions covered by our team at the conference and in our offices in New York.

10x Genomics

10x Genomics more than doubled its revenue in 2018 over 2017, CEO Serge Saxonov said during his presentation on Monday. The firm's total 2018 revenues were $146 million, up from $71 million in 2017. The company has placed more than 1,000 of its instruments, up from 500 by the end of 2017, and has more than 4,000 active users, Saxonov added.

Saxonov also said that the company plans to launch a new product in 2019 that will pair single-cell gene expression with spatial information. The product will make use of technology developed by Spatial Transcriptomics, a Swedish startup that spun out of the Science for Life Laboratory in Stockholm and that 10x acquired last month. Spatial Transcriptomics' technology involved overlaying a thin tissue slice on a slide that contained nucleic acid probes. Barcodes that preserve spatial information are attached to the mRNA molecules, which are then prepared for sequencing. Saxonov said that 10x is working on a product that would combine this technology with the firm's single-cell technology and would launch in 2019.

Looking ahead, Saxonov projected that the company's total addressable market would grow to $53 billion by 2022, up from $42 billion in 2018, driven by growth in the single-cell market, which is just "in the earliest stages," as well as in immuno-oncology and the broader precision medicine market, Saxonov said.

In 2018, the firm launched a number of new products, including single-cell ATAC-seq, which is based on technology the company secured by acquiring Stanford spinout Epinomics. In addition, it launched several products that make use of feature barcoding, or the ability to look at multiple aspects from one cell, such as proteins and gene expression. It also launched a third version of its single-cell gene expression kit. Saxonov noted that in the first few months of launching the single-cell ATAC-seq kit, it quickly became the firm's fastest selling product. Pharmaceutical companies have shown a particular interest in the feature barcoding kit that combines single-cell gene expression with CRISPR-induced mutations, enabling high-throughput functional studies. Pharmaceutical companies see that as a way to "zero in" on the right target and the right drugs, Saxonov said.

Also this week, 10x said that it had raised $35 million in an extension of its Series D financing round. The company said last month that it plans to expand in 2019, including adding a new manufacturing site and increasing its workforce by 50 percent.

Myriad Genetics

On the heels of a publication of the results of a randomized controlled study on Myriad Genetics' pharmacogenetic test GeneSight, which aims to guide treatment for patients suffering from depression, Myriad CEO Mark Capone said that the test is the firm's "most important from the standpoint of future growth," representing a $5 billion total addressable market in the US.

He noted that the firm plans to submit a dossier to private payors and Medicare this week for reimbursement. Overall, Capone said that the firm's new products have been driving volume growth. In fiscal year 2013, less than 1 percent of testing volumes were from new products, but in fiscal year 2018, 76 percent of testing volumes derived from new products. A significant amount of that growth was driven by the acquisition of Counsyl, which closed last July. That enabled Myriad to expand into the reproductive health market, with Counsyl's carrier screening and noninvasive prenatal tests.

Going forward, Capone said that Myriad plans to triple the number of sales reps for its prenatal products this month in order to push into the Ob/Gyn market, which he said is underpenetrated. Most other NIPT firms have focused on the maternal fetal medicine market, he said, since maternal fetal medicine specialists typically handle high-risk pregnancies for which NIPT is reimbursed. However, Capone said that NIPT for average-risk pregnancies is being increasingly accepted and some payors are covering it, noting that an anticipated endorsement by the American College of Obstetrics and Gynecologists sometime this year would help secure broader reimbursement.

Aside from Counsyl's tests, an important acquisition was the app Counsyl developed, Counsyl Complete, essentially a "one-stop shopping for [prenatal] tests to order by the Ob/Gyn," Capone said. "It automates the process from the time the patient comes into the office to the test result." Capone said that Myriad eventually plans to apply that app, which it will rebrand as Myriad Complete, to the company's entire portfolio of tests.

Bruker

Bruker Chairman President and CEO Frank Laukien provided an update on all the firm's businesses and end markets including its MALDI Biotyper, a system used for microbial identification that is viewed as a success story for clinical proteomics. According to Laukien, the firm has an installed base of around 3,200 Biotyper systems around the world. And while sales growth for the system has slowed to the high-single digits, Laukien pointed out that about half the revenues associated with the platform are now coming from consumables, which are growing at a much higher rate.

The firm is working on multiple assays for the Biotyper system including blood culture identification and susceptibility testing. Laukien said that its rapid SepsiTyper product for bloodstream infections has been launched in Europe, and the firm is planning trials this year in advance of a filing for marketing clearance from the US Food and Drug Administration.

Through its acquisition of Hain Lifescience in August 2018, Bruker now has several assays marketed or in development for many infectious diseases including tuberculosis, sexually transmitted diseases, and HIV. The acquisition is part of a larger effort by Bruker to expand its microbiology offerings beyond the mass spec-based MALDI Biotyper system.

Laukien noted that Bruker has a pipeline of assays it is developing using Hain's Liquid Array format, and in particular it aims to develop syndromic panels that will be launched in 2021 and beyond. It aims to launch a TB Liquid Array panel this year.

Laukien noted that Bruker made eight acquisitions in 2018 for a total of $190 million. Hain was one of those deals, but Laukien said the firm has placed recent emphasis on beefing up its informatics capabilities, and singled out its deal last month to take a majority stake in Mestrelab Research, a Spanish firm that has developed software for spectroscopic data from platforms such as mass spectrometry and NMR.

Konica Minolta

Aaron Elliott, CEO of Ambry Genetics, which Konica Minolta acquired in 2017 for $1 billion, discussed the genetic testing portion of the overall company's business and how it is working with another of Konica Minolta's businesses, imaging company Invicro. Elliottt noted that both Ambry and Invicro continue to operate as independent subsidiaries under the Konica Minolta Precision Medicine arm of Konica Minolta. Kiyotaka Fujii serves as CEO of Konica Minolta Precision Medicine. And, a separate branch of Konica Minolta is a Japan-focused precision medicine business, which it launched last September and is run by Ken Masuo.

At the conference, Elliott said that Ambry has now run more than 1.5 million genetic tests, the vast majority of them next-generation sequencing tests, and receives, on average, orders from 11,000 clinicians from more than 4,000 institutions per year. Its tests are in-network with around 95 percent of the insured population, he said, and its CLIA-certified, CAP-accredited lab has the capacity to process 3,000 samples per day. In addition, he said, the firm runs a translational genomics lab that can conduct variant classification. Elliott noted that for one class of variant, splice site variants, RNA testing was able to reduce the number of variants classified as being of unknown significance to 8 percent from 92 percent.

Kenneth Bloom, who serves as chief medical officer of both Ambry and Invicro, said that the company has been working on combining the high sensitivity tissue testing (HSTT) technology that Invicro has been developing with Ambry's genomic testing. Bloom described the HSTT technology as a "secondary detection system for immunohistochemistry that's very high sensitivity but without amplification." It is based on nanoparticle detection technology and is quantitative. In a 2017 study published in Scientific Reports, Invicro described using the technology to quantify the level of HER2 expression.

Bloom said that the company is currently collaborating with several pharmaceutical companies to use the technology and is collaborating with some academic partners to see if "we can use the same substrate for HSTT and then go on to do deeper molecular profiling," he said.

More broadly, Bloom said that he thinks imaging will have a larger role to play in diagnosis in the future and that in combination with genomic testing, it could be a powerful diagnostic tool that would also expand Ambry's market.

Geisinger

Jaewon Ryu, Geisinger's interim president and CEO, said that the integrated health system began offering routine clinical sequencing to its patients last July, following its pilot program that it announced last May.

The offering was born out of its MyCode Community Health Initiative, a research project that originally began as a biobank initiative in 2007 but expanded to include exome sequencing in partnership with Regeneron Pharmaceuticals in 2013. Participants who enroll in the research project receive results back for 76 genes related to hereditary cancer, cardiovascular conditions, and other genetic disorders.

Ryu said that more than 225,000 participants had enrolled in MyCode as of November 2018 and that 1,046 positive findings had been returned to patients. But because those results have implications for an average of five relatives per positive result, he estimated that in total, around 5,000 individuals were at risk.

During his presentation, he highlighted one patient's story — a 60-year-old man who had a history of heart disease, including a heart attack at age 35 and a heart transplant at age 45. He enrolled in MyCode and discovered he had a mutation that impacted the ability of his LDL receptors to get rid of bad cholesterol. Not only did that provide an explanation for his previous heart conditions, but importantly, it prompted testing in his son, who was also found to have the mutation. "That has dramatically altered the care plan for the son," Ryu said.

Ryu noted that Geisinger recognized around $8 billion in 2018 revenues.