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In Brief This Week: Exact Sciences, Hologic; Myriad Genetics; Cepheid; Bio-Rad Laboratories; Ambry Genetics; GNS Healthcare; Horizon Discovery; Interleukin Genetics; Kreatech; BioSignatures

NEW YORK (GenomeWeb News) – Exact Sciences said in its 10-K filing with the US Securities and Exchange Commission this week that in December it entered into an amendment to a licensing agreement pursuant to which Hologic granted the company a non-exclusive worldwide license to certain Hologic patents within the field of any disease or condition within, related to, or affecting the gastrointestinal tract and/or appended mucosal surfaces. The amendment is to an agreement the firms signed in 2009.

Myriad Genetics said this week that that three federal agencies including the US Department of Health and Human Services, the US Department of Labor, and the US Department of the Treasury have issued a set of FAQs clarifying that BRCA testing qualifies as a preventive service under the provisions of the Affordable Care Act. "Importantly, this clarification will allow for BRCA testing to be completed with no patient cost sharing for all non-grandfathered private insurance plans when an asymptomatic woman has a qualifying family history," Myriad said in a statement.

For more on the FAQs and Myriad's response please see GenomeWeb Daily News sister publication Pharmacogenomics Reporter.

In a filing with the SEC this week Cepheid disclosed some of the revenue it has received through its high-burden developing countries contracts. It said that it received a one-time payment of $3.5 million from the Bill and Melinda Gates Foundation during the third quarter of 2012 and a one-time payment of $3.5 million from the United States Agency for International Development during the fourth quarter of 2012.

In addition, based on the terms of the agreements, Cepheid said that it is recognizing revenue related to the BMGF and USAID agreements on a per-unit basis. For the year ended Dec. 31, 2012, the firm recognized $4.8 million of revenue related to the BMGF and USAID agreements.

It also entered into an agreement with UNITAID during the fourth quarter of 2012 and received a contingent payment of $3.2 million in the first quarter of 2013, and it may receive an additional payment of $900,000 in 2013. Under the UNITAID agreement, if certain terms are met, Cepheid said that it may recognize up to $4.1 million of revenue related to that agreement on a straight line basis over a period of 10 years, beginning in the third quarter of 2013.

Bio-Rad Laboratories said this week that it would file its annual report with the SEC after the due date of March 1 because it hasn't finalized an assessment of the effectiveness of its internal control over financial reporting. It also hasn't finalized an accrual for royalties payable by the company at Dec. 31 related to patent licenses from a third party. The firm said that it would file its Form 10-K as soon as practicable.

Ambry Genetics said this week that it has surpassed a milestone of performing 10,000 diagnostic next-generation sequencing tests and more than 100,000 total genomic samples sequenced for its customers. In 2011 the firm began offering whole-exome sequencing through its Clinical Diagnostic Exome service. It also has launched NGS panels for Marfan syndrome and primary ciliary dyskinesia.

GNS Healthcare announced this week that it has joined in the formation of Orion Bionetworks, a research alliance that will take on a number of diseases, starting with multiple sclerosis. GNS will build predictive, computational models to yield new information about the disease, it said. Other alliance members include Accelerated Cure Project for Multiple Sclerosis, the Institute for Neurosciences at Brigham and Women's Hospital, and PatientsLikeMe, among others.

Horizon Discovery has established three new Centers of Excellence for gene editing in Asia. The new Centers are at Aichi Cancer Center, Japan; Seoul National University, South Korea; and the National Cancer Centre, Singapore. Horizon said that it will support the three research centers in their application of its proprietary gene engineering technology, called Genesis, to generate human isogenic cell lines harboring specific genes/mutations relating to cancer.

Interleukin Genetics announced that it has entered into a three-year Preferred Participation Agreement with Renaissance Health Service Corp. RHSC, a dental benefits provider, has agreed to reimburse Interleukin an undisclosed, fixed price for each PST genetic risk panel for periodontal disease severity and tooth loss susceptibility that it processes for its customers.

Kreatech said this week that the Lung Cancer Mutation Consortium will use its Repeat-Free Poseidon FISH probes to help identify changes in study samples. The US consortium is prospectively examining non-small cell lung cancer tumors for molecular changes linked to patient response to available therapies.

Newcastle, UK-based Biosignatures has received ISO 9001:2008 and ISO 13485:2003 certification. The firm specializes in proteomics and protein separation techniques for developing and validating diagnostic and prognostic biomarkers.

In Brief This Week is a Friday column containing news items that our readers may have missed during the week.