Illumina and Qiagen partner to deliver sequencing-based IVD tests
November 2019—Illumina announced on Oct. 7 a 15-year partnership intended to broaden the availability and use of NGS-based in vitro diagnostic kits, including companion diagnostics.
The agreement grants Qiagen nonexclusive rights to develop and globally commercialize IVD kits to be used with Illumina’s MiSeq Dx and NextSeq 550Dx systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic systems. Both partners are also exploring opportunities for Qiagen to develop and market companion diagnostics based on Illumina’s TruSight Oncology assays.
Illumina and Qiagen will cooperate to commercialize a menu of clinically validated workflows that combine Qiagen’s proprietary content and bioinformatics solutions. The partnership will focus initially on commercializing oncology IVD kits and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, and inflammatory and autoimmune diseases.
Francisco Partners to acquire Orchard
Francisco Partners, a technology-focused private equity firm, announced Sept. 30 its intent to acquire Orchard Software.
“We look forward to the partnership with the FP team and are excited about fueling what has made Orchard successful with additional expertise and capital to accelerate our growth and continue to bring innovation to our customers,” Rob Bush, founder and CEO, said in a statement.
As part of the transaction, Billie Whitehurst will succeed Bush as CEO. Whitehurst has more than 20 years of experience leading health information technology businesses, most recently as senior vice president at Netsmart. Prior to that, Whitehurst held senior roles at Change Healthcare and McKesson.
“Francisco Partners’ deep experience in health care technology and proven track record in nurturing and growing technology businesses will enable Orchard Software’s loyal base of employees to continue delivering market-leading solutions and new innovations,” Whitehurst said in the statement. (See page 76 in this issue for CAP TODAY’s Q&A with Bush and Whitehurst.)
Orchard specializes in seamless integration, advanced rules-based decision support, and data analytics. “Orchard has been the pioneer in the LIS industry, developing market-leading products and maintaining strong, long-standing customer relationships,” Jonathan Murphy of Francisco Partners said in the statement. “They are well positioned to continue to drive product innovation in the LIS market, and we are excited about the opportunity in POCT and partnering with the team to accelerate the company to new levels of growth and impact for laboratorians across the U.S.”
Beckman receives funding to develop sepsis algorithm
Beckman Coulter has been awarded a contract of $1.25 million, with potential to be awarded an additional $6.5 million if all contract options are exercised, from the Division of Research, Innovation, and Ventures established by the Biomedical Advanced Research and Development Authority. The authority, known as BARDA, is under the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.
The contract will enable Beckman Coulter, in collaboration with science and technology company Dascena, to develop and commercialize a machine-learning-based sepsis detection algorithm that will combine novel laboratory test parameter values with electronic health record information. The objective for this next-generation analytic algorithm will be to accurately predict and detect sepsis earlier, Beckman Coulter said in a statement.
“This project integrates the novel laboratory parameters generated on the Beckman Coulter DxH 900 hematology analyzer into Dascena’s best-in-class sepsis prediction and detection algorithm,” David Persing, MD, PhD, chief scientific officer for the Danaher diagnostics platform, said in the statement. “We aim to leverage the unique ability of the DxH 900 to detect changes in monocyte distribution width and combine the results, along with other diagnostic parameters and vital sign data, with a multimodal algorithm expected to achieve unprecedented levels of performance.”
Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures—vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products—needed to combat health security threats.
FDA clears Ortho Sera
The Food and Drug Administration cleared Ortho Sera, Ortho Clinical Diagnostics’ suite of extended antigen phenotyping, for use on the Ortho Vision Analyzer.
Ortho Sera’s antisera additive approach allows extended phenotyping to be personalized according to patient need. The 13 Ortho Sera reagents available in the U.S. on the Ortho Vision Analyzer are Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-D (IAT), Anti-D (DVI), Anti-P1, Anti-Lea, Anti-Leb, and Anti-N.