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In Brief This Week: Biocartis, Celcuity, Immunovia, and More

NEW YORK (360Dx) – Belgian MDx firm Biocartis said this week that it is adjusting its guidance for 2018, increasing its projection for new instrument placements and narrowing its expectation for cartridge volume.

The firm said it saw continued strong growth in its installed base in the third quarter, with the US leading Idylla instrument placements. As a result, the company increased its guidance for the full year to 300 new instrument placements, up from a range of 250 to 275 that it reported at the end of the first half of 2018.

Commercial cartridge volume for the first nine months of 2018 also doubled year-over-year, the firm said. Based on that performance, the company narrowed its full-year guidance to 130,000 - 135,000 commercial cartridges, an approximately 90 percent increase over 2017. 

Among other recent milestones, the company said it is seeing promising initial market adoption of its Idylla MSI assay — launched as a research-use-only product in July — and is on track to claim a CE-mark for the assay early next year. The firm also highlighted its joint venture with Wondfo to commercialize Idylla products in mainland China. According to Biocartis, the venture will be owned 50-50 by itself and Wondfo and initial activities will be focused on the local manufacturing, commercialization, and regulatory registration of existing Idylla products for colorectal and lung cancer. 

Biocartis continues to expect to file premarket authorization documentation with the US Food and Drug Administration for its Idylla RAS test towards end 2019, subject to feedback from the FDA. It expects to launch a liquid biopsy version of the Idylla EGFR mutation test in the first half of 2019, and to release a planned RUO kit version of Genomic Health's Oncotype Dx test in the second half of next year. 

It ended the quarter with an unaudited $91.6 million, and expects to end the year with $62.2 million.

Celcuity this week reported a net loss of $1.9 million, or $.18 per share, for the third quarter of 2018, compared to a net loss of $1.8 million, or $.26 per share, for the third quarter of 2017. On an adjusted basis, the firm's net loss for Q3 was $.15 per share.

The Minneapolis, Minnesota-based cellular analysis company did not report revenues. It is commercializing diagnostic tests designed to improve the clinical outcomes of cancer patients treated with targeted therapies.

Celcuity Chairman and CEO Brian Sullivan said in a statement that the firm is getting ready to implement a clinical trial agreement inked in October with Puma Biotechnology and the West Cancer Center. The trial will evaluate the efficacy of Puma’s pan-HER inhibitor Nerlynx (neratinib) in early stage triple-negative breast cancer patients who have hyperactive HER2 signaling tumors identified by Celcuity's CELx HSF Test. The trial administrators anticipate enrolling up to 27 patients beginning in early 2019. Celcuity said it expects to obtain interim results in 10 to 12 months after the first patient is enrolled and final results within 18 to 24 months.

The firm is continuing to advance the development of its CELx Signaling Function tests for breast cancer and two new tissue types, Sullivan said. Celcuity is also engaged in a clinical trial in collaboration with Genentech and the NSABP Foundation, he added. 

For Q3, the firm's R&D expenses were up 14 percent to $1.6 million compared to $1.4 million for the prior-year quarter, and its general and administrative expenses rose 229 percent to $376,796 from $164,665.

As of Sept.  30, Celcuity had cash, cash equivalents, and investments of $26.7 million.

Immunovia said that four additional North American familial pancreatic cancer sites have joined the firm’s PanFAM-1 prospective study investigating the early diagnosis of hereditary risk of pancreatic cancer in high-risk individuals. The new participating centers are the Research Institute of the McGill University Health Centre, the Trustees of the University of Pennsylvania, the University of Massachusetts, and Yale University. 

Started in 2016, PanFAM-1 is designed to validate Immunovia’s blood-based test IMMray PanCan-d and will analyze more than 2,000 individuals over three years across sites in Europe and the US that already offer FPC screening programs. An interim analysis is planned for the end of 2019 with an interventional phase planned for completion in 2021, Immunovia said. The company is also running a study for another recently identified high-risk group, new onset diabetics older than 50 years of age.

IntegraGen announced this week that it plans to collaborate with Google Cloud to implement IntegraGen’s genomic analysis tools Sirius and Mercury into the Google Cloud Platform. This collaboration will facilitate important genomics research projects and aid in the analysis of sequencing data, enhancing the adoption of personalized approaches to medical care, the company said. Mercury is a biological interpretation tool for oncology designed to help pathologists and oncologists transform raw high-throughput sequencing data into a clinical molecular report for diagnostic and clinical use. Sirius provides researchers with ease of use and speed of analysis despite considerable volumes of data being analyzed.

Agilent Technologies this week declared a quarterly dividend of $.16 per share of common stock, payable on Jan. 23, 2019, to all shareholders of record on Dec. 31, 2018.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.