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In Brief This Week: Novacyt, Promega, Natera, and More

NEW YORK (360Dx) – Novacyt said this week that its revenue from continuing operations for full-year 2018 will be in the range of €13.7 million to €14.4 million ($17.4 million to $18.3 million), following its decision in December to sell its Novaprep cytology business and clinical laboratory operations. That estimate, which includes revenues from the company's Primerdesign and Lab21 diagnostic reagent units, compares to a market consensus of €15.9 million.

The shortfall, Novacyt said, is primarily due to confirmed tender orders totaling more than €1 million that won’t ship until the next financial period. Cash at the end of year is anticipated to be between €800,000 and €1 million, it added.

Novacyt said it would sell the Novaprep business and clinical lab operations to focus on in vitro diagnostic product development and the profitable Lab21 and Primerdesign business units.

Promega said this week that its newest microsatellite instability (MSI) technology has been granted innovation designation by the Chinese National Medical Products Administration (NMPA). The innovation status will make the technology's path toward classification as an in vitro diagnostic more efficient, Promega said, as the NMPA will assign a program coordinator and priority status for multiple processes.

This version of the Promega MSI platform is trademarked ProDx in China. It's a PCR-based method for detecting MSI and is currently being accessed globally in investigator-initiated trials to determine its application in solid tumors beyond colon cancer. In the US, Promega said it intends to seek Food and Drug Administration (approval for IVD status of the MSI 1.2 platform.

Natera said this week that it has received two Z codes for its cell-free DNA-based cancer test, Signatera, which it plans to launch clinically in the second quarter of this year. The test is aimed at detecting minimal residual disease and to monitor treatment response. The Z codes, ZB8DC and ZB8DD, cover multiple cancer types and are used to identify the test when seeking reimbursement from third party payors.

Tübingen, Germany-based CeGaT said this week that it has received a CLIA license and accreditation from the state of California, enabling it to operate in 49 US states. The company's US subsidiary, Pennsylvania based-B. Braun CeGaT, is responsible for its North American business.

GeneNews said this week it has inked a deal with Three Rivers Provider Network for early cancer detection tests from GeneNews' Innovative Diagnostic Laboratory. Three Rivers is a provider network with 200 million lives that have access to IDL services. GeneNews/IDL also entered into an agreement with MultiPlan, which contracts with 900,000 healthcare providers across the US and has about 60 million consumers accessing MultiPlan network products.

Also this week, GeneNews entered into a second convertible security funding agreement with Lind Asset Management XI for C$500,000 ($$368,000) in convertible securities. The financing will allow the company to "accelerate its initiatives with large healthcare providers to increase the rate of implementation, as well as begin rebranding," GeneNews Chairman and CEO James Howard-Tripp said in a statement.

OrigiMed said this week that it has completed its Series B financing round, which was led by Grand Flight Investment. The pre-A Series financing investor Wedo Capital also continued to invest, the company noted. OrigiMed did not specify how much funding it raised but said that it would use the financing to fund R&D and expand the influence of its oncology precision medicine data platform in China.

OrigiMed provides molecular diagnostic sequencing for cancer patients as well as molecular pathology and genomics services for biopharma partners developing biomarker-driven drugs. The company has run 10 million cancer panel tests in China. Its assays target a wide range of solid tumor types and can guide both targeted treatment and immunotherapy.

Fulgent Genetics, the Precision Genomics Laboratory (PGL), and the department of obstetrics and gynecology at Columbia University Irving Medical Center (CUIMC) announced this week that they are partnering to make on-site, expanded carrier screening available to Columbia patients. The PGL is jointly operated by the Institute for Genomic Medicine (IGM) and the Department of Pathology and Cell Biology and is designed to enhance patient care through genomic diagnostics, research, and education at CUIMC.

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.