NEW YORK ─ Microarray test developer Quotient has entered the market for transfusion diagnostic testing with a multiplex, multimodal platform and is eyeing the development of the system for additional diagnostic applications.
Though sales of the firm's manually applied Alba by Quotient reagents currently account for almost all of the Eysins, Switzerland-based company's revenues, Quotient believes its automated microarray platform, MosaiQ, will become a mainstay of its future revenue growth, said Manuel Mendez, who took over as the company's new CEO at the beginning of April.
MosaiQ is a fully automated and consolidated testing platform currently used for blood grouping and transfusion-transmitted infection screening of donated blood.
Quotient has developed it "to enhance clinical decision-making and provide considerable operating efficiencies, both in a donor-testing environment and in patient-testing contexts in the future," Mendez said in an interview.
The firm is positioning the system as an alternative to testing for blood grouping and infections transmitted by the transfusion of donated blood that is usually done manually or by single-use automated systems.
The ability of MosaiQ to perform multiplexing testing for immunohematology, serology, and molecular biomarkers using one platform means a single system could be deployed to replace several instruments in transfusion and diagnostic labs, Mendez said.
MosaiQ uses two microarray-based testing chambers that can test for up to 66 analytes or parameters per chamber. That enables laboratories to run any of its available antigen and antibody tests and will include molecular tests in the future, he said.
To fund the firm's ongoing development of the multimodal MosaiQ platform and prepare it for commercial launch, in May, Quotient announced that it was selling $95 million of its 4.75 percent convertible senior notes in a private offering.
The firm has launched MosaiQ with immunohematology and serological disease screening microarrays in European markets. Quotient obtained CE marking in 2019 for an initial immunohematology, or IH, microarray running on the MosaiQ platform for transfusion diagnostics. In 2020, it obtained CE marking for its initial serological disease screening, or SDS, microarray, which includes immunoassays for cytomegalovirus and syphilis, used for transfusion diagnostics.
The company is preparing to launch a multiplexed Expanded IH + Initial SDS microarray for the same applications in Europe by the end of this year, and it is planning a 510(k) submission to the US Food and Drug Administration for the initial SDS microarray around the same time.
Quotient said it expects to participate in 25 European tenders for placements of MosaiQ during this fiscal year and next and has commitments from 12 customers to evaluate its platform and tests. The firm has placed the initial IH microarray with nine European customers as part of a program it calls Hypercare.
Transfusion diagnostics, the company's initial focus for the adoption of MosaiQ, has a total available market worth $3.4 billion, but more lucrative markets could be in store for the firm because of the multiplexing and multimodal characteristics of its platform, according to Mendez.
"We can see a significant opportunity for this platform in both transfusion and clinical diagnostics," Mendez said. "In the clinical diagnostics area, its multiplexing capabilities and unique way of combining immunohematology, serology, and molecular testing on one platform can play a central role." The first clinical tests on the MosaiQ platform could be available within the next two years, he said.
Each of its testing modalities is a mainstay of both transfusion diagnostics and diagnostics, in general, but customers operating in both IVD segments often need to purchase three different instruments to conduct the same tests that can be conducted using one MosaiQ platform, he said.
By combining multiplexing and multiple testing modalities, Quotient's customers have the potential to save on costs through more efficient workflows, use fewer laboratory technicians for testing, and achieve space savings that would otherwise be taken up by more laboratory instruments, according to Mendez. The multimodal, multiplexing MosaiQ platform can help address lab complexity, staffing shortages, budget constraints, and the safety of the blood supply, he said. "Our internal analysis indicates that for many customers, we can provide overall operational savings of about 20 percent," he added.
In a research note last month, BTIG research analyst Sung Ji Nam said, "Quotient is on track to begin to take a meaningful share in the transplant diagnostics market over the next 18 to 24 months in Europe and the US." Longer term, the investment bank believes that the diagnostic company has the capability to address other applications in the broader IVD market, she added.
Mendez said that he believes the MosaiQ platform's multimodal, multiplexing features will play well in markets for oncology testing as well as syndromic testing for infectious diseases. He is currently evaluating areas the company might enter first for clinical diagnostics but is not disclosing specific plans.
In the diagnostics market, where testing is usually done using immunoassay or molecular testing instruments, MosaiQ could be deployed to conduct multiple types of tests simultaneously and to simplify testing workflows, he said. For example, its multiplexing capabilities could be employed to detect many disease analytes at once for syndromic testing, when clinicians find it particularly difficult to distinguish conditions based on symptoms.
"For molecular disease screening, my intent is to initially evaluate patient and clinical pathways for the potential to develop testing panels," Mendez said. "In women's health, for example, it may be possible to offer a panel that includes tests for breast cancer, cervical cancer, and ovarian cancer on the same platform."
Further, the move into the broader diagnostics space, with a market size more than elevenfold that of transfusion diagnostics, would significantly boost the firm's total addressable market, Mendez noted.
Mendez joined Quotient in April from Quest Diagnostics where he was the senior vice president and chief commercial officer. He was previously a senior vice president and head of global commercial operations at Qiagen, and held senior leadership roles with Abbott, Thermo Fisher Scientific, OraSure Technologies, and BioMérieux.
The new CEO replaced Franz Walt, who had been the firm's CEO since 2018. Earlier this month, Peter Buhler, Quotient's CFO, announced that he is resigning to take a position with another company. Mendez said Quotient expects no impact on its current or future financial and business strategies as a result of Buhler's departure.
In June, the company had announced that Michael Hausmann, senior director of global R&D in the clinical diagnostic division of Thermo Fisher Scientific will join Quotient as its CTO in the second fiscal quarter of 2022.
Quotient, traded on the Nasdaq since 2014, was established a decade ago as a spinoff from the Scottish National Blood Transfusion Service. It reported revenues of $43.4 million, up 33 percent year over year from $32.7 million, for its fiscal year 2021, which ended on March 31.
Its revenue growth was driven largely by sales of its Alba by Quotient immunohematology reagents used primarily to identify blood group antigens and antibodies in donor and patient blood and to perform daily quality assurance testing for third-party blood grouping instrument platforms.
The microarray platform and its tests have multiple levels of complexity that add to the challenge of launching them in the market, and Quotient has been accumulating the expertise and knowledge needed to develop and launch its tests for the past few years, Mendez said.
"It can be difficult to develop a single test, but we are developing panels on a glass surface within a multiplexing platform," he said. "We've accumulated the right skill set to be able to understand how these panels need to behave and how to incorporate the right level of components — whether it is the buffers, detection technology, or the carousels used to incubate reactions, for example."
The firm also has had to master the manufacturing of its microarrays using a high level of automation required to print "small dots on glass with each representing a different analyte or testing parameter," he added.
As it proceeds with commercialization plans for its first tests, the firm is also broadening its diagnostics menu and recently announced that it completed the optimization of an expanded immunohematology microarray with additional blood antigen typing tests.
Quotient is developing an expanded serological disease screening microarray, which includes immunoassays for HIV 1&2, HBV, and HCV. European and US field trials are expected to commence at the end of this year, and a CE mark submission is planned for the first fiscal quarter of 2023.
Mendez said that the company expects its molecular disease screening microarray will deliver levels of sensitivity comparable to those of the highest performing molecular tests, and in internal evaluations, the system it is developing has shown concordance with Roche Diagnostics' Cobas molecular diagnostic system.