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In Brief This Week: Exosome Dx, Theradiag, CAP, Qiagen, and More

NEW YORK (360Dx) – Exosome Diagnostics said this week that it has expanded the coverage of its ExoDx Prostate IntelliScore (EPI) cancer test to an additional 82 million covered lives in the US, bringing the total to about 100 million. The firm said that the additional coverage is the result of contracts to provide laboratory services and ExoDx prostate cancer testing to patients of three preferred provider organizations in the US — Three Rivers Provider Network, FedMed, and America’s Choice Provider Network.

Exosome Diagnostics CEO and President John Boyce said in a statement that the firm expects to announce "additional coverage decisions in the first quarter."

Theradiag this week announced 2017 revenues of €9.1 million ($11.2 million), up 1 percent from €9 million in 2016.

For the year ended Dec. 31, 2017, the firm's in vitro diagnostics revenues were €4.9 million, down 2 percent from €5 million in 2016, and its Theranostics business revenues were €4.2 million, up 4 percent from €4 million in the previous year.

Eighty percent of the firm's Theranostics revenues were due to sales of its CE-marked Lisa Tracker, a multiparametric diagnostic for the management of patients with autoimmune diseases treated with biotherapies. The firm noted that Lisa Tracker revenues, which were up 20 percent year-over-year, consisted of direct sales to hospitals and medical analysis laboratories and sales obtained through partnerships with Inform Diagnostics, Janssen, Biogen, Merck Sharp & Dohme, and Hospira/Pfizer.

Theradiag said that the rest of its Theranostics revenues consisted primarily of sales from ad hoc studies conducted for its pharmaceutical and diagnostics partners. The revenues are not recurring but could represent a first step toward future commercial agreements, it said.

As of Dec. 31, 2017, Theradiag's available net cash was €5.2 million.

The College of American Pathologists has filed an amicus curiae in support of the American Clinical Laboratory Association’s request for summary judgement to set aside new Medicare reimbursement rates for laboratory tests. The rates were implemented by the US Department of Health and Human Services on Jan. 1, creating new market-based rates for a wide range of diagnostic tests conducted in laboratories. ACLA originally sued HHS in December saying the agency did not follow the directions from Congress to establish the new rates, which were created as part of the Protecting Access to Medicare Act. At issue, in particular, are the types of labs whose data were used by HHS to establish the new PAMA rates. ACLA and CAP contend that the vast majority of hospital labs were incorrectly excluded from the process, resulting in rates that did not reflect true market rates for test reimbursements, which were used to calculate PAMA rates.

Qiagen has opened Qiagen Business Services in Manila, its new shared-service center in the Philippines. QBS Manila will provide services related to supply chain management, customer care, and accounting, as well as technical services and other sales support activities to Qiagen's global operations. Supporting Qiagen businesses specifically in the US and the Asia Pacific region, QBS Manila is expected to play an important role in the global provision of services to the company and its clients. Total headcount in Qiagen's Manila site is expected to reach about 200 over the next 18 months. The new center complements Qiagen's existing shared service center in Wroclaw, Poland, which has grown to more than 350 employees since opening in 2013.

TATAA Biocenter said it has expanded its digital PCR offerings with Stilla Technologies' three-color digital PCR system Naica. Michael Kubista, founder and CEO of TATAA Biocenter, noted that digital PCR is the "most important complement" to qPCR and next-generation sequencing and can be used for standardization, copy number variation, and rare mutation analysis. He added that the addition of the Naica system is a "major strengthening" of TATAA's service and training offerings.

Bruker has acquired high-speed infrared imaging microscopy firm IRM for an undisclosed amount. IRM’s products are based on quantum cascade laser methods, and the deal expands Bruker’s technology portfolio and market opportunities for infrared microscopy, Bruker said. It noted, in particular, the fields of biological tissue analysis and materials science, as well as possibly tissue diagnostics in the future.

Sygnis said this week that it has extended an OEM agreement with an unnamed global life sciences tools firm that is expected to generate annual revenues of more than €800,000 ($986,000) over the two years of the contract. In addition, Sygnis said it is in discussions with the partner to supply it with its Expedeon Lightning-Link labeling reagents for use in commercially available research assays.

Danaher’s board approved a regular quarterly dividend of $.16 per share, payable on April 27 to shareholders of record on March 29.

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.