SAN FRANCISCO (GenomeWeb) - The 37th annual JP Morgan Healthcare Conference wrapped up on Thursday with a handful of life science tools and molecular diagnostics companies presenting to attendees who stuck around to the end. Below are brief reports on the presentations and breakout sessions covered by our team at the conference.
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Meridian Bioscience is looking to launch a new molecular testing platform to shore up declining sales and put its diagnostics business back on track, CEO Jack Kenny said in a presentation Thursday.
Demand during the recently completed quarter was softer than anticipated for Meridian's life sciences and diagnostics segments, but the firm saw most of the weakness in MDx products. Without new product development, the molecular business will likely continue to decline, Kenny said during a breakout session after his presentation Thursday.
The firm anticipates commercializing an MDx instrument that provides automated capabilities from sample to result as well as multiplexing. The platform could use PCR rather than isothermal amplification, the technology enabling its existing MDx platforms, Kenny said.
Meridian is looking internally and externally to determine the best way to get an advanced MDx system quickly to market, he said. The firm is interested in developing a gastrointestinal menu that includes assays for H. pylori and C. difficile and that physicians routinely use in office settings, Kenny said. The firm also has plans to launch respiratory MDx tests, including for Strep Aand influenza.
Combining use of MDx with rapid immunoassays is becoming the standard of care for C. difficile testing, and that presents a "significant opportunity" because the firm has both types of platforms, Kenny said.
From a customer perspective, Meridian is already in a "strong position in the pediatric point-of-care space with [its] lead testing systems," he said.
Pediatricians using lead testing products are also looking to run additional tests for their patients, Kenny said, which presents an opportunity to provide several tests consolidated onto one platform. The firm is building out a strategy to meet that market need, he said.
Large reference laboratories and small- to mid-size hospitals are already using the firm's H. pylori testing products. And a collaboration that the firm inked with DiaSorin in October enables it to offer the test to laboratories in large hospitals that prefer to not send out the test to reference labs, Kenny said.
The firm said this week that its preliminary fiscal first quarter revenues are expected to be down about 2 percent year over year.
Following nearly five years of silence, CEO of next-generation sequencing firm Genapsys, Hesaam Esfandyarpour, said that a commercial launch of its portable sequencer will happen this year and that its early-access customers include researchers at the HudsonAlpha Institute for Biotechnology, which has two systems running, and Stanford University. Esfandyarpour first previewed the instrument, called Genius, for Gene Electronic Nano Integrated Ultra Sensitive, at the Advances in Genome Biology and Technology meeting in 2014. The system is about the size of a toaster and uses sequencing-by-synthesis with electronic detection.
At this week's JP Morgan Healthcare Conference, Esfandyarpour said that the company had made progress on chip development, placing some systems with early-access users, and generating internal data. It also completed a $40 million Series C financing round in 2017.
He said that the firm now has two chips developed — one with one million sensors and a second with 16 million sensors — and is working on a third chip that will have 144 million sensors. Esfandyarpour said that the company plans to finish development of its third chip and also raise additional capital this year.
The system itself will be priced around $10,000 with average run costs at about $300 and turnaround time in one day. Currently, researchers input a prepared sequencing library, but Esfandyarpour said that the company is also working on developing an automated sample prep instrument, as well as a second version of the platform itself that would have sample prep and sequencing integrated. Depending on the chip, the system will be able to run small targeted sequencing assays up to exomes. Internally, the firm has done exome sequencing on the platform using the Genome in a Bottle reference samples, and Esfandyarpour said that error rates were low at .01 percent for substitutions, .03 percent for deletions, and .04 percent for insertions. He added that it planned to publish that data this year.
Biocartis placed 326 instruments in 2018 bringing its total installed base of its Idylla platform to 973 instruments, Ewoud Welten, Biocartis' CFO, told investors. In addition, he said, the company sold 133,000 cartridges last year, up from 71,000 in 2017.
The molecular diagnostic firm's Idylla platform is based on qPCR technology, but Welten noted that the system outperforms other qPCR platforms due to the extensive automation and optimization. Looking ahead to 2019, he said one key in driving the business will be the completion of its automated manufacturing facility in Belgium, which will have the capacity of producing 1 million cartridges per year, up from its current capacity of 225,000 cartridges.
He also noted that its partnership with Genomic Health would be particularly fruitful, enabling Genomic Health to place the content of its Oncotype Dx Breast Score test on the Idylla platform. Genomic Health said earlier this week that it planned to commercialize that test in France and Germany in 2020.
In addition, Genomic Health will also develop a prostate cancer test on Idylla. Welten said that test would be launched first in the US market and would also include US Food and Drug Administration 510(k) clearance of Idylla.
Most of Biocartis' assays focus on gene mutations for which there are clinical guidelines around testing. However, it is also developing a microsatellite instability assay, which researchers from Memorial Sloan Kettering Cancer Center and Dartmouth Hitchcock Medical Center presented data on last November.
The MSI assay is currently available as a research-use-only test, but Welten said the firm planned to secure CE marking for it this year.
Molecular diagnostic firm Veracyte recognized an estimated $90.5 million in 2018 revenues, CEO Bonnie Anderson told investors this week. In addition, she said the firm anticipated being cash-flow break even before the end of 2019, a timeline that was accelerated by the recent deal with Johnson & Johnson Innovation to develop a nasal swab test that uses RNA sequencing for early lung cancer detection, as well as the second generation of Veracyte's Percepta genomic classifier, which is used in conjunction with bronchoscopy to rule out lung cancer.
Johnson & Johnson will have access to the sequence data generated as part of the collaboration in order to develop its own targeted therapeutics. While Anderson said that there is the possibility Veracyte might develop a diagnostic to go along with a J&J compound, that is not the goal of the collaboration and would depend in part on whether whatever therapeutics J&J ended up developing even required a companion diagnostic. In addition, she said Veracyte's focus was on an early detection test.
Initial data from the firm's early detection studies are expected this year, Anderson noted.
Regarding new products in development, Anderson said in an interview following her presentation that for the immediate future, the company was focused on first driving adoption of its three assays — its Afirma thyroid cancer test; the Percepta test for lung cancer; and Envisia, which helps in diagnosing idiopathic pulmonary fibrosis — but she said that its next focus would be to develop tests both upstream and downstream of its current products for either early detection or to further stratify patients and inform treatment. In addition, she said, the company is working on new indications, but declined to disclose which indications or a timeline for development.