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JP Morgan Healthcare Conference Day Four: Luminex and Exact Sciences

SAN FRANCISCO (GenomeWeb) – The 35th Annual JP Morgan Healthcare Conference continued this week with several life science research tools and diagnostic firms making presentations to investors and other attendees.

The following are summaries of presentations and breakout sessions on Thursday by Luminex and Exact Sciences.

Luminex

Luminex CFO Harriss Currie said the firm has halted development work on the next generation of its Aries platform, dubbed Aries v2, in order to devote its resources to developing the next generation of Nanosphere's Verigene platform, which the firm is calling Project Atlas.

Luminex acquired Nanosphere last year for $77 million. With that deal it gained ownership of the Verigene platform, a multiplex molecular diagnostics system offering higher plex syndromic testing and a complementary platform to the firm's Aries, which offers targeted testing.

The Aries system and first assay for the instrument, for herpes simplex 1 and 2 virus, were cleared by the US Food and Drug Administration in October 2015. It has since received FDA clearance for a flu A/B and respiratory syncytial virus assay, and just last week announced clearance of its Aries Group B streptococcus assay. It also has FDA clearance for the Aries M1 System, a lower-throughout version of the Aries designed for use in smaller satellite labs.

Currie said that the firm aims to have seven cleared assays for the Aries system by the end of 2017, and among those is a test for C. difficile. The firm has placed 90 Aries systems thus far, he noted.

He also reiterated an earlier disclosure by the company that LabCorp intends to shift to next-gen sequencing technology for its cystic fibrosis testing by mid-year 2017,  and it has indicated to Luminex a desire to shift its women's health testing performed using Luminex's reagents to the Roche Cobas 8800 system by mid-year 2018.

At last year's JP Morgan Healthcare Conference, Luminex CEO Homi Shamir said that the firm was increasing its focus on the development and sale of analyte-specific reagents. Though company officials didn't spend much time discussing that aspect of Luminex's business, Shamir said during a Q&A after Currie's presentation that the ASRs are opening up demand for the Aries, and the firm is considering converting some of those ASRs to in vitro diagnostics.

Earlier this week, Luminex reported preliminary fourth quarter revenues of $72 million, up 20 percent year over year, and 2016 revenue of $271 million, up 14 percent. It also said that last month it reorganized "to both facilitate the integration of Nanosphere and to better focus" on its core business, reduce its headcount by more than 50 employees, reallocate responsibilities within the R&D organization, and "significantly" reduce its biodefense efforts.

Currie noted today that its molecular diagnostics revenue grew to $122 million in 2016. Sales of Nanosphere's Verigene system totalled $31 million, up 46 percent year over year.

Currie said the firm is aiming for $45 million in sales for the Verigene platform in 2017, with total revenues for the company estimated at $295 million to $305 million for the year.

Exact Sciences

On the heels of better-than-expected preliminary fourth quarter and FY 2016 revenues, Exact Sciences' CEO Kevin Conroy discussed the firm's plans to leverage the technology it developed for it Cologuard colorectal cancer screening test to enter the liquid biopsy market.

During his presentation, he said that in collaboration with researchers at the Mayo Clinic, the company has made significant progress on identifying methylation markers associated with different cancer types that can be analyzed via liquid biopsy using its technology.

The firm has been collaborating with the Mayo on the development of assays for lung, liver cancer, and pancreatic cancer. For the lung cancer assay, he said that they have achieved high accuracy in identifying eight methylation markers that can be identified in blood. From 136 cancer samples and 119 controls, the team demonstrated a sensitivity of 98.5 percent and 100 percent specificity with an Area Under the Curve of .998.

Similarly, for three methylation markers associated with liver cancer, they demonstrated 98 percent sensitivity and 97 percent specificity from 21 cancer samples and 33 controls. And finally, the team has validated two methylation markers that can be identified from pancreatic cyst fluid with a sensitivity of 95 percent and specificity of 90 percent from 14 cancer samples and 61 controls.

He said the firm plans to focus on commercializing the lung cancer assay first and early in the second quarter, the firm's collaborators at the Mayo Clinic will present data from a 370-patient study of stage I, II, and III cancers and controls.

Conroy said that Exact Sciences is targeting the 1.5 million to 3 million patients annually in the US in whom a lung nodule is discovered on a scan. For most of those patients, the nodule is not cancer, he said, but the current screening methods are not sensitive or specific enough.

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