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In Brief This Week: Danaher, Natera, Chembio, and More

NEW YORK (360Dx) – Ahead of Danaher's presentation at the 37th annual JP Morgan Healthcare Conference in San Francisco this week, the Washington-based conglomerate said that its fourth quarter core revenue growth is expected to be above its previous guidance of about 4 percent growth, while adjusted EPS would be at or near the previous estimate of between $1.25 to $1.28. Growth was driven by its life science and diagnostics businesses, the firm said.

Natera said this week that it has entered into an amended credit agreement with OrbiMed Royalty Opportunities, extending the period under which Natera may borrow funds and increasing the amount available to the San Carlos, California-based molecular diagnostics firm. The original agreement was signed in August 2017 and provided Natera with a $100 million senior secured term loan facility. Natera borrowed $75 million the same month the agreement was signed and had until the end of 2018 to request the remaining $25 million. The firms have come to an agreement to extend the period under which Natera can borrow funds to March 31, 2019, and have increased the remaining amount of money it can draw to $50 million.

Chembio Diagnostics announced this week it has received CE marking for a diagnostic test developed in collaboration with AstraZeneca. Chembio said that the quantitative test detects an undisclosed biomarker using the firm's DPP platform but did not provide further details.

The partners announced a deal in December 2017 to develop the point-of-care test. Under the terms of the 18-month agreement, AstraZeneca will provide Chembio with up to $2.9 million in funding, subject to the satisfaction of certain milestones. 

Precipio said this week it has been approved by the US Department of Defense as a domestic vendor within the Foundation for the Advancement of military medicine. The designation means DOD-funded medical centers can use the company's ICE COLD PCR technology for mutation testing for active military members as well as military veterans. Precipio has received its first order from a DOD hospital, which evaluated the company's technology with those of other firms, and delivery is anticipated this month.

Separately, in a document filed with the US Securities and Exchange Commission Precipio said it has entered into a deal with an unnamed third-party service provider under which Precipio will pay the provider $550,000 in return for the cancellation of a $1.47 million debt owed by Precipio. 

ArcherDx announced this week that its companion diagnostic assay has received a Breakthrough Device Designation from the US Food and Drug Administration. ArcherDx said that the designation will allow it to work with the FDA as it prepares its submission for full approval of the assay.

First Light Biosciences said this week that it has changed its name to First Light Diagnostics. The Chelmsford, Massachusetts-based company develops products for the rapid and cost-effective diagnosis of life-threatening antibiotic-resistant infections. The name change reflects the company's evolution from development to commercialization of diagnostic solutions, it said.  

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.