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In Brief This Week: Roche, Interleukin Genetics, Alere, CSI Laboratories, Trinity Biotech, and More

NEW YORK (360Dx) – Roche said this week that it had established a strategic alliance with Poplar Healthcare of Memphis, Tennessee, which makes Poplar part of the Roche Molecular Center of Excellence for the next five years.

The Center of Excellence, which includes around 30 diagnostic labs, was established in 2002 to enable non-competing, regional laboratories in the US to “collaborate and capitalize on scientific knowledge in molecular testing and, in turn, help accelerate the advancement of new test methods and technology,” Roche said in a statement. 

Poplar Healthcare brings expertise in anatomic and molecular pathology, oncology, and women's health to the alliance, and "we look forward to working together to implement molecular technologies for the advancement of personalized medicine," Whitney Green, senior vice president, commercial operations at Roche Diagnostics, said in a statement.

Interleukin Genetics said that it inked an agreement with Spang & Company to offer the Ilustra Inflammation Management Program to its employees and their families as an enhancement to the company's employee benefits plan.

The Ilustra program is for managing inflammation in patients. It targets individuals with elevated risk for severe periodontitis due to a genetic tendency to overproduce inflammation.

Spang & Company is an employer-member of the Pittsburgh Business Group on Health, an employer-led coalition. As a member of the coalition, Spang received early access to the Ilustra Program, and it expects to deploy it in May.

Alere said in a filing with the US Securities and Exchange Commission that it is unable to file its annual report on Form 10-K for fiscal year 2016 within the prescribed time without unreasonable effort or expense. The firm had already been given an extension, which expired on March 16.

Alere said in the filing this week that it would be unable to file its 2016 Form 10-K within the extension period because it is continuing to review certain aspects of revenue recognition at its Korean and Japanese locations, including inappropriate conduct at Standard Diagnostics, its subsidiary in South Korea. The company did not provide additional details about the inappropriate conduct.

The firm said in the filing that it expects that this review will result in a change in revenue for fiscal year 2013 of around $0 to $5.0 million; a change to revenue for fiscal year 2014 by around $0 to $5.0 million; a decrease in revenue for fiscal year 2015 by around $5.0 million and $10.0 million; and an increase in revenue for the nine months ended Sept. 30, 2016, by around $5.0 million and $10.0 million.

Alere noted that it will not be able to file its 2016 Form 10-K until this review of revenue recognition at its Korean and Japanese locations is completed, and it expects to file the 2016 Form 10-K "as soon as practicable."

CSI Laboratories announced a service agreement with Avalon Healthcare Solutions, a laboratory benefits coordinator. This partnership will make CSI an in-network provider of specialized cancer diagnostic services for most of South Carolina payers that use Avalon’s services, CSI said.

Patients in South Carolina with insurance plans contracted with Avalon will have access to CSI’s medical diagnoses, rapid turnaround times, and quality-based testing services, CSI said.

The firm noted that hospitals will also benefit from its partnership with Avalon.

Horizon Discovery Group said this week that it has inked an agreement with an undisclosed developer and provider of molecular diagnostic testing solutions, which involves developing and manufacturing reference standards for "three common forms of noninvasive prenatal testing."

The project, anticipated to be completed within 12 months, will provide Horizon with a minimum of £800,000 ($983,770) in product revenue, the firm said.

Under the terms of the agreement, Horizon will use its gene editing capabilities to develop reference standards to be used by the diagnostic testing solutions provider for in-house assay development, and to support clinical trials for regulatory approval through the US Food and Drug Administration. The reference standards for the project will be designed to model clinical samples and will be used as a whole-process control, from extracting DNA from a patient sample to final determination of the genotype, Horizon said.

Dublin-based Trinity Biotech reported revenues for the fourth quarter of $23.7 million, down 5 percent from $24.9 million in the fourth quarter of 2015.

For the three months ended Dec. 31, 2016, the firm's point-of-care revenues slipped to $4.0 million, down 27 percent from $5.4 million in Q4 2015. This was due to fluctuation patterns which impacted HIV sales in Africa, Trinity said.

Clinical laboratory revenues were $19.7 million, an increase of 1 percent from $19.5 million in Q4 2015.

The firm said that it had a net loss, after taxes and once-off items, of $100.9 milion, or $3.73 per share in Q4 2016, compared to a profit of $2.8 million, or $.11 per share, in Q4 2015.

The company had a profit of $4.9 million, before once-off items, in the recently completed quarter, it said. It took a charge of $66.3 million for asset impairment related to the withdrawal of its 510(k) submission to the US Food and Drug Administration of the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer. The firm also took impairment charges of $43.4 million for assets not related to Meritas, as well as a product cull charge of $4.8 million. The tax impact of its once-off charges was a credit of $8.7 million for a total once-off charge of $105.8 in Q4 2016.

Trinity reported 2016 revenues of $99.6 million, down 6 percent from $100.2 million in 2015.

For 2016, point-of-care revenues were $16.9 million, a 10 percent dip from $18.8 million in 2015. Its clinical laboratory revenues were $82.7 million, up 2 percent from $81.4 million in 2015.

Trinity's net loss for 2016 was $100.6 million, or $3.45 per share, compared to a profit of $21.8 million, or $.46 per share, in 2016,

GeneNews said this week that it has inked an agreement with an undisclosed "large, multi-specialty physician group" in the American Midwest for use of its cancer diagnostic tests. It's the firm's second partnership agreement with a US healthcare services group, and it marks the introduction of the firm's BreastSentry diagnostic test to the US market.

Patients of the medical group will have access to GeneNews' screening tests — ColonSentry, earlyCDT-Lung, Prostate Health Index, and BreastSentry — which provide early-risk stratification of colorectal cancer, lung cancer, prostate cancer, and breast cancer, respectively.

GeneNews will process the samples through its CAP- and CLIA-certified clinical reference laboratory in Richmond, Virginia.

Agilent Technologies this week announced that it will pay a quarterly dividend of $.132 cents per share on April 26 to shareholders of record as of the close of business on April 4.

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