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Quotient Preps MosaiQ Blood Transfusion Diagnostic Platform for European, US Launches

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NEW YORK (GenomeWeb) – Quotient, a Swiss diagnostics company that provides reagents and services for blood screening, is in the midst of introducing an automated antigen microarray system called MosaiQ that it hopes will "industrialize" transfusion medicine.

CEO Paul Cowan said that the company aims to wrap up field trials for the system by the end of this year after which it will seek CE-IVD marking to enable a European launch. Quotient is also preparing to trial MosaiQ with partners in the US next year ahead of filing the platform with the US Food and Drug Administration.

'Both field trials will require the demonstration of concordance with the results of predicate technologies," said Cowan, adding that doing so is a "precursor to approval for sale" for blood-screening systems.

For Quotient, the launch of the MosaiQ system is part of an effort to transform the way blood transfusion is done, moving clients at companies and laboratories away from conventional methods to a more efficient, higher-throughput setup.

The system relies on two panels: MosaiQ IH Microarray for blood grouping and MosaiQ SDS Microarray for disease screening. Both should provide the transfusion diagnostics market with one system that can offer automated blood antigen typing, antibody detection, and disease screening. Quotient hopes to sell the system to donor centers and hospital blood banks.

Quotient was established a decade ago when it was spun out of the Scottish National Blood Transfusion Service. In addition to its headquarters in Eysins, it maintains a facility in Edinburgh, as well as a site in Newtown, Pennsylvania. It is also traded on the Nasdaq, and reported total revenues of $22 million for its fiscal year 2017, which ended on March 31.

Sales of reagents for antibody screening, antigen testing, and other purposes generate the majority of Quotient's revenues, in addition to its original equipment manufacturing services. Much of these businesses are managed from the company's Edinburgh facility, which produces blood grouping and control products that are sold both directly to end users and also under a variety of private label arrangements to transfusion diagnostic companies, Cowan said.

Quotient's focus for the future, though, is MosaiQ, for which the company built its own microarray manufacturing facility at its location in Eysins, north of Geneva.

According to Cowan, MosaiQ is enabled by an internally developed protein and red blood cell antigen microarray technology that is capable of identifying red cell antigens and antibodies for immunohematology testing, as well as screening for transfusion transmittable infections. He said the platform was developed to address inefficiencies associated with using existing approaches, such as qualitative chemiluminescent immunoassays or nucleic acid amplification testing.

"MosaiQ was born from a 'what if?' question," said Cowan. "Could traditional transfusion diagnostics be miniaturized and automated to reduce the cost, time, and variability that arises today from the human and instrument interface?" he said.

The company also wanted to develop a system that would simplify workflows and supply chains, and to reduce the amounts of samples and reagents required for current methods of analysis.

"It is a well-known fact that imperfect information contributes to the cost of a process and creates waste and inefficiencies," said Cowan. "This holds true for the current approach to transfusion medicine because of resource constraints," he said.

Quotient instead would like to provide patients that require repeated transfusions, for example, with routine access to matched blood that reduces the potential for alloantibodies, Cowan noted. He added that MosaiQ could also be used to flag donors with rare blood types so that they can be encouraged to donate on a regular basis.

To bring these ideas to life, Quotient developed its own automated microarray platform,  tapping into the expertise of several external collaborators. Creating MosaiQ called for a "new way of printing and constructing arrays," Cowan said.

"Essentially, we have developed a way to industrialize transfusion medicine diagnostics," he said. "The microarray approach is game changing in many ways." The technology should attract users that find conventional approaches limited, Cowan added, noting that it is currently impossible to conduct universal extended antigen phenotyping of red blood cells and antibody identification for all donors and all recipients because of cost and manual techniques.

"The existing technologies cannot come close to achieving the workflow efficiencies required to provide the information that MosaiQ can routinely deliver," Cowan said. Not only should that provide blood banks and donor centers with more data, but MosaiQ will also reduce the time it takes to group and screen blood samples, enabling users to increase volumes while reducing costs.

For this reason, Quotient believes that customers will make the investment to acquire the system, which does not yet have a publicly disclosed price tag. "The required up-front investment in instrumentation will be minimal for prospective customers as a result of both the design of the system and our proposed business model," said Cowan. He noted that MosaiQ will allow clients to redirect resources to tasks "where their expertise will be put to better use than routine manual testing." It should also enable donor clinics and blood banks to improve their activities, he said.

"MosaiQ ... will facilitate the development of a blood supply that is not only efficiently deployed and managed but also used to its fullest potential," said Cowan.

Quotient is not the first firm to see array technology as a solution to the constraints facing the transfusion diagnostics business. Immucor, a Norcross, Georgia-based provider of transfusion and transplantation products, acquired BioArray Solutions in 2008, ultimately gaining a CE-IVD mark and FDA 510(k) clearance for its PreciseType Human Erythrocyte Antigen Test in 2014. That same year, Barcelona-based Grifols gained a CE-IVD mark for ID Core XT, a multiplex test for molecular blood group typing run using Luminex instruments.

Companies have also turned to next-generation sequencing to support new blood screening assays. Immucor earlier this year launched the Mia Fora NGS Flx HLA Typing Assay, which provides comprehensive coverage of up to 11 human leukocyte antigen genes.

According to Cowan, though, Quotient is "not aware of any technology" in the transfusion medicine space that provides the same information that MosaiQ can provide. While the company does not expect to file the platform with European and US regulators until 2018, it is providing regular updates on internal evaluations of the system. Earlier this month, it reported between 98 percent and 100 percent concordance with predicate technologies for MosaiQ's array-based antigen typing, antibody detection, and disease screening tests.