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In Brief This Week: 23andMe, Danaher, Natera, and More

NEW YORK (GenomeWeb) – Consumer genomics firm 23andMe announced this week that it has inked a deal with Lark Health to enable its customers to access Lark’s personalized artificial intelligence coaching for weight loss and type 2 diabetes prevention. 23andMe’s research has uncovered genetic variants associated with body weight and has identified lifestyle choices that contribute to weight differences between individuals with similar genetic information. Lark and 23andMe's product science team incorporated this research into Lark’s AI coaching programs to personalize food recommendations for customers based on 23andMe's genetic testing reports.

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.

Formulatrix, a Bedford, Massachusetts-based company developing microfluidic technologies for protein crystallization and nucleic acid testing, said this week that its digital PCR assets are being acquired by Qiagen for up to $260 million, including $125 million in upfront payments and $135 million in milestones. Qiagen CEO Peer Schatz also disclosed the acquisition earlier this week at the JP Morgan Healthcare conference, noting that Qiagen plans to launch a new digital PCR platform based on Formulatrix's technology in 2020.

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 military members on active duty as well as veterans. Precipio has received its first order from a DOD hospital, which evaluated the company's technology with 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.

Saphetor, maker of the VarSome genomic annotation software tool, announced this week that it has partnered with the Englander Institute for Precision Medicine at Weill Cornell Medicine. As such, the institute's Precision Medicine Knowledgebase is now one of the more than 30 public data resources that informs VarSome, Saphetor said.

FACIT, an Ontario-based business accelerator,, announced this week that it has invested additional funding in Toronto-based start-up DNAstack, which is developing advanced data standards and technologies to find, access, analyze, and share large multi-omic datasets in the cloud. FACIT did not specify the amount of the investment, but said that it would take an active role on DNAstack's board in conjunction with the new funding.

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.

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.

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 developments to commercialization of diagnostic solutions, it said.

Empirical Bioscience said this week that it has received ISO 13485:2016 certification for Medical Device and Quality Management Systems, which is an upgrade from its previous ISO 13485:2003 certificate. This new certification more closely aligns with US Food and Drug Administration regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry, the firm said. ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing, and sale of medical devices that are safe and effective for their intended purposes. To receive such a certification, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

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