CLN Article

Industry Playbook

Miroculus, Kapplex Strive to Advance microRNA Testing With Digital Microfluidics

Miroculus, a biotechnology company that specializes in microRNA-based diagnostics, has entered an agreement to buy the Toronto-based firm Kapplex. Kapplex has developed a proprietary digital microfluidics platform for immunoassays and molecular diagnostics that builds on research at the University of Toronto. With this acquisition, Miroculus aims to use Kapplex’s digital microfluidics technology to automate and simplify the detection of microRNAs in blood related to complex conditions, such as cancer or infectious diseases, in a minimally invasive way. By combining their technologies, the two companies also hope to reduce the cost of microRNA tests in order to make these assays available in limited resource settings.

“We see increasing demand for decentralized testing, and both companies are dedicated to improving patient-centric care while bringing the diagnostics closer to patients in an automated, accurate, and affordable way,” said Alejandro Tocigl, Miroculus’ CEO. “Combining our efforts will allow us to combine novel microRNA detection chemistry, bioinformatics, and database support with [Kapplex’s] powerful and versatile microfluidic platform.”

In the future, Miroculus also plans to use Kapplex’s technology to expand beyond microRNAs and develop other types of disease biomarkers.

Siemens Acquires Liquid Biopsy Company

Siemens Healthineers has bought the Cologne, Germany-based company, Neo New Oncology, as part of an expansion strategy to enhance its portfolio of molecular testing-related services and technologies for oncology and genomics. Neo New Oncology is developing molecular profiling assays based on next-generation sequencing, both for tissue specimens and body fluids. This includes Neoliquid, a liquid biopsy test that uses the company’s third-generation hybrid capture technology to analyze circulating tumor DNA in order to determine the genomic profiles of solid tumors. Neo New Oncology also has a cancer genome diagnostic platform called Neo that is designed to help pathologists and oncologists select targeted cancer therapies.

“The acquisition of Neo New Oncology will allow us to offer high-quality oncology tests and related services for physicians, hospitals, and laboratories,” said Sebastian Kronmueller, head of molecular services at Siemens Healthineers. “Covering both blood-based and tissue-based genomic tests, we will be able to provide clinically actionable results based on the latest scientific insights.”

Roche Prenatal Test Now Covered by Largest National Private Insurance Health Plans

Insurance coverage in the U.S. for Roche’s Harmony cell-free DNA prenatal test has been expanded to include in-network status with the four largest national private insurance health plans, increasing total coverage to approximately 200 million people. The Harmony test was developed by Ariosa Diagnostics, a CLIA-certified laboratory that Roche acquired in 2015. The test measures the risk of chromosomal conditions such as trisomy 13, 18, or 21. Ariosa’s non-invasive prenatal testing (NIPT) service is also accessible to patients covered by Medicaid in multiple states across the country. This Medicaid coverage now includes Medi-Cal in California, making the Harmony test one of the most widely covered NIPT tests in the U.S., according to Roche.

Weill Cornell Medicine, Garvan Institute Enter Genomic Data Sharing Agreement

Weill Cornell Medicine, through the Caryl and Israel Englander Institute for Precision Medicine, is collaborating with the Garvan Institute of Medical Research in Sydney, Australia, to combine their databases of genomic information. These two organizations will employ two systems to share de-identified genomic data: CBioPortal, which includes a user interface for browsing genomic profiles, and Beacon, a tool for sharing genomic variants across larger population cohorts. By merging their databases, the Englander and Garvan Institutes aim to help researchers look for patterns and trends in cancer across large patient populations. The collaborators hope that any resulting findings that show clear patterns will help inform the design of new clinical trials.

“Sharing knowledge about the types of mutations we identify at the Englander Institute for Precision Medicine with a world-class genomics partner increases our ability to make sense out of rare findings,” said Mark A. Rubin, MD, director of the Englander Institute. “If a mutation only occurs in one percent of the patient population at Weill Cornell Medicine, having the added experience from the Garvan will help us determine if the prevalence of the mutation is real.”

Fluxion Biosciences, UTHealth Team on Liquid Biopsies for Prostate, Other Cancers

Fluxion Biosciences has partnered with the University of Texas Health Science Center at Houston (UTHealth) to develop novel liquid biopsy approaches to improve the diagnosis, monitoring, and treatment of cancer patients. Under the terms of the agreement, Robert Amato, DO, director of the Division of Oncology at UTHealth Medical School, will use Fluxion’s IsoFlux System to isolate, recover, and analyze rare circulating tumor cells (CTCs) at the molecular level. The IsoFlux system employs a novel microfluidic capture technology to recover CTCs with high efficiency and purity, according to Fluxion. This enables the use of highly multiplexed analyses such as next-generation sequencing for cancer mutational profiling. Initially, UTHealth plans to leverage this technology to develop blood tests for prostate, kidney, and bladder cancers. In particular, one major aim of the partnership will be to identify markers that help stratify patients requiring more aggressive treatment from those who don’t, a major challenge in treating prostate cancer.

Takara Bio USA, IDT Partner on RNA Sequencing

Takara Bio USA and Integrated DNA Technologies (IDT) have joined forces to support targeted RNA sequencing and analysis of the transcriptome. “We believe that RNA sequencing holds great promise for medical research and diagnostics, as well as for identification of novel therapeutic targets,” said Lorna Neilson, PhD, director of corporate development at Takara Bio. “For example, the technique can be used to correlate changes in gene expression with disease initiation and progression, and identify other transcriptomic changes that drive diseases such as cancer.”

The two companies will leverage IDT’s expertise in manufacturing long oligonucleotides as well as Takara Bio’s experience in developing low-input solutions for next-generation sequencing applications. Together, they plan to explore probe design and kits for low-input, targeted RNA sequencing applications that could enable the identification and characterization of rare transcripts in small samples.

Quest, Safeway to Expand Lab Testing Services to Five New States

Quest Diagnostics and Safeway have joined forces to offer diagnostic testing in 12 Safeway locations, in addition to the two locations currently operating in Arizona through Quest’s Sonora Quest Laboratories joint venture with Banner Health. The Safeway stores are located in California, Colorado, Texas, Virginia, and Maryland. The patient service centers will be adjacent to Safeway’s in-store pharmacies and will feature interior designs built to facilitate a secure and private environment. The service centers will also have a waiting room and a dedicated restroom with a sample pass-through. Quest plans to give patients remote contact devices that will enable them to shop during wait times. “We’re building on what we learned in Arizona, which is that by providing laboratory testing services where patients also shop, we will make it easier for them to get the quality diagnostic insights they need in convenient locations,” said Steve Rusckowski, president and CEO of Quest Diagnostics.

PCR Market Climbs to $3.5 Billion

The total polymerase chain reaction (PCR) technologies market was valued at about $3.5 billion for 2015, up from $3.2 billion in 2013, according to a Kalorama Information report, “qPCR and dPCR Markets (Instruments, Reagents, Software/Services).” The report attributes this rise to the fact that PCR technologies are increasingly being used to diagnose infectious diseases, detect antibiotic resistance, explore cancer mutations, and detect genetic abnormalities. Competition in the PCR technology market is also steadily escalating in the U.S. and Europe, a trend that is encouraging more participation in other areas such as Asia and Latin America. The report focuses specifically on analyzing the market for quantitative PCR (qPCR) and digital PCR (dPCR), which show significant promise for expanding diagnostic applications, according to Kalorama. “qPCR has established itself as the workhorse in the research laboratory,” said Bruce Carlson, publisher of Kalorama Information. “But dPCR’s potential is greater in diagnostic applications due to its sensitivity, precision, robustness, and reproducibility.”

Foundation Medicine and AstraZeneca Partner to Create Co-Dx for Cancer Drug

Foundation Medicine will begin work with AstraZeneca to create a companion diagnostic assay for Lynparza (olaparib), a poly ADB-ribose polymerase (PARP) inhibitor currently used in the U.S. to treat women who have germline BRCA-mutated advanced ovarian cancer. The oral PARP inhibitor exploits tumor DNA repair pathway deficiencies to target cancer cells, and has the potential to treat a range of tumor types with DNA repair deficiencies.

Using the Quality Systems Regulations-compliant version of its genomic profiling platform, Foundation Medicine plans to develop a novel assay capable of detecting multiple classes of genomic alterations involved in homologous recombination repair (HRR). This test could subsequently assist physicians in identifying patients who could benefit from Lynparza based on the presence of specific genetic mutations. The assay is based on a panel of genes known to play a role in driving the HRR process, and will be developed alongside the clinical program for Lynparza as part of a coordinated drug-diagnostic regulatory strategy.

Metabolon, Johns Hopkins, and Tufts to Develop Kidney Function Test

Metabolon has entered an agreement with Johns Hopkins University and Tufts Medical Center to develop accuGFR, a test that is intended to improve the determination of glomerular filtration rate (GFR) in order to aid in the diagnosis of chronic kidney disease. In routine clinical practice, GFR is estimated using creatinine, but only about two-thirds of creatinine-based eGFR results are within 20% of the patient’s measured GFR (mGFR). This partnership aims to identify more accurate markers that could be used in place of creatinine. In collaboration with Johns Hopkins and Tufts, Metabolon has evaluated hundreds of patient samples using its advanced metabolomics technology to verify the clinical utility of novel metabolite markers of kidney function. These applied metabolomics biomarkers form the basis of the accuGFR test, which is currently being developed and clinically validated against the gold standard mGFR.

Beckman Coulter to Place Ortho Immunodiagnostic System in Very High-Volume Labs

Ortho Clinical Diagnostics’ Vitros 3600 immunodiagnostic system and infectious diseases menu will soon be available in labs that currently run Beckman Coulter Diagnostics’ Power Processor Sample Handling Systems, following the recent announcement of the two companies’ partnership. Using MicroWell technology, the Vitros 3600 system tests for infectious diseases through chemiluminescence detection in serum, plasma, urine, whole blood, or amniotic fluid samples. Laboratories will be able to use the system for running HIV and hepatitis assays. The two companies will also collaborate to obtain approval from the Food and Drug Administration to connect Ortho’s immunoassay system to Beckman’s sample handling system in order to run infectious diseases tests. “Ortho has long been a pioneer in infectious disease testing. Our relationship with Beckman will help us deliver that expertise to their large installed base of automated labs,” said Alex Socarrás, executive vice president of global commercial operations at Ortho.