NEW YORK ─ MindX Sciences has begun marketing a laboratory-developed blood test that uses RNA expression biomarkers to enable more precise detection and treatment for patients with depression, manic disorder, and post-traumatic stress disorder, among other psychiatric conditions.
In a recent study published in Molecular Psychiatry, the firm collaborated with researchers at Indiana University and other academic institutions to identify, prioritize, and validate a set of blood-based gene expression biomarkers for tracking and predicting the severity of mood disorders including depression and mania.
The Indianapolis-based firm recently reached a milestone, Alexander Niculescu, MindX cofounder, chairman, and CSO, said in an interview, by inking a deal with Q2 Solutions, the laboratory division of Durham, North Carolina-based Iqvia, that enables testing for a range of psychiatric disorders. Further, Q2 Solutions this week announced that it is using whole-transcriptome analysis to process the RNA expression blood tests in its CLIA-certified laboratories.
"The partnership with Q2 Solutions provides a way for us to start testing via an early-access program that will last through the rest of 2021," Niculescu said.
MindX was founded with the aim of developing precision diagnostic testing for psychiatry, a field lacking in objective methods to support decisions about diagnosis and treatments, said Niculescu, who is a professor of psychiatry at Indiana University. The company's tests are based on technology licensed from Indiana University.
Niculescu said that the firm provides information and recommendations based on its testing for physicians who make the final call about diagnosis and treatment. Its target customers are physicians — usually primary care doctors and sometimes psychiatrists working in hospitals — who are evaluating patients for mood disorders; pain; post-traumatic stress disorder; suicide risk; memory disorders; and longevity.
MindX has identified diagnostic panels for each application. It is also in conversations with pharma companies interested in using its tests in clinical trials to develop psychiatric drugs.
The Molecular Psychiatry study involved testing samples from about 300 patients over four years, who were recruited mainly from the Richard L. Roudebush VA Medical Center in Indianapolis.
The investigators identified biomarkers by tracking changes in RNA expression in samples from patients who were classified as clinically depressed or manic using standard scales for mood disorders. The researchers applied a convergent functional genomics approach to search an internal database of published literature and prioritize the biomarkers that they had identified. They then tested the biomarkers' ability to detect people who had been classified as manic or depressed.
The overall study yielded a 13-biomarker panel that showed high performance in the detection of patients with depression and mania but also in predicting the future severity for each condition, said Niculescu, who is the lead author.
Though blood testing to evaluate patients for psychiatric disorders is a nascent field, gene expression "biomarkers will be powerful for taking away some of the subjectivity in this area," said Michael Snyder, director of the Center for Genomics and Personalized Medicine at Stanford School of Medicine. Snyder's laboratory is researching multiomics approaches — combining RNA, protein, and metabolic biomarkers — for the detection of psychiatric and other medical conditions, but he is not affiliated with MindX.
Snyder noted that psychiatric conditions, including mood disorders, are usually diagnosed using questionnaires that are open to subjective interpretation and with questions that are sometimes altered between tests, affecting consistency and the comparison of results. By contrast, a molecular biomarker panel can provide objective information from a test that can be repeated and compared as needed, Snyder said.
The recent and previous studies by MindX "is something that is really needed in this field," he added. However, these studies are just a beginning, and before the MindX blood tests can become broadly accepted, additional validation is needed to ascertain the clinical utility of sets of biomarker panels for the conditions targeted by the researchers, he said.
In MindX's early-access program, physicians mail tubes containing patient blood samples to a Q2 Solutions laboratory that performs transcriptional profiling to measure RNA expression and provides results to MindX, which provides a report to the ordering physician.
The development of transcriptional profiling blood tests "serves several unmet needs in the areas of depression, pain, and mood disorders," Q2 Solutions CEO Brian O’Dwyer said in an email. "While therapeutic areas such as oncology have invested heavily into precision medicine approaches to patient care in recent years, MindX is leading the way to bring precision medicine approaches into psychiatric care."
Early in April, Quest Diagnostics announced that it sold its minority share in Morrisville, North Carolina-based Q2 Solutions to Iqvia for $760 million in an all-cash transaction. Quintiles and Quest had launched Q2 Solutions as a joint venture in 2015. A year later, IMS Health, a provider of pharmaceutical market data, merged with Quintiles to form QuintilesIMS, which was subsequently renamed Iqvia.
Niculescu said that Q2 Solutions can handle all MindX blood testing for the foreseeable future.
MindX's operations are currently supported by a seed round of financing and it could seek additional funding in a Series A round later this year, he said, to support the hiring of additional staff and handle an anticipated increase in testing demand. The company has not disclosed the amount of the seed round or of the additional funding it is seeking.
MindX uses internal sales and product support staff to target customers and plans to increase hiring for those roles as it scales up testing. The company also anticipates seeking reimbursement for its blood tests from the US Centers for Medicare and Medicaid Services and private payers and applying for Current Procedural Terminology codes to facilitate reimbursement.
In the meantime, people will have to pay out-of-pocket for testing that is "not inexpensive" since it involves RNA sequencing, Niculescu noted. As a result, the firm is highly focused on seeking test reimbursement, which would lower the barrier to obtaining testing. Current pricing for MindX tests is undisclosed and negotiated on a case-by-case basis with doctors' offices and hospitals, he said.
Further, after additional validation of its blood tests, the company plans to seek approval from the US Food and Drug Administration, which would also increase test acceptance, Niculescu said.