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Tufts and Partners to Evaluate Targeted Genomic Sequencing Panel for Newborns

Industry Playbook: October 2018

Tufts and Partners to Evaluate Targeted Genomic Sequencing Panel for Newborns

Tufts Medical Center researchers and several collaborators have received a 5-year grant award for more than $8 million from the National Center for Advancing Translational Sciences of the National Institutes of Health to study integrating targeted genomic sequencing into neonatal diagnosis and care. The six-site study will evaluate the accuracy and efficacy of a targeted genomic sequencing panel that analyzes 1,722 genetic disorders known to affect newborns and that Tufts is developing in conjunction with Quest Diagnostics. In addition to Tufts, the other study sites include Rady Children’s Institute for Genomic Medicine, Mt. Sinai Hospital, University of North Carolina at Chapel Hill, Cincinnati Children’s Hospital, and the University of Pittsburgh. The study will recruit 400 newborns with a wide variety of possible genetic disorders unable to be diagnosed using standard testing. Each infant will undergo whole genome sequencing in addition to testing with the targeted panel. The researchers will then compare the two approaches for accuracy and efficacy in identifying genetic disorders, and will determine whether the targeted panel can be safely integrated into newborn care.

The study also will conduct statistical and health economic analyses to determine if, and how much, targeted genomic testing for newborns would save the healthcare system. Since targeted screening is less costly than whole genome sequencing, the collaborators believe targeted testing could lead to substantial savings in addition to improving the standard of care.

Genedrive, FIND to Assess HCV Kit for Limited-Resource Settings

Genedrive and the Foundation for Innovation of New Diagnostics (FIND) have teamed to evaluate the performance of the Genedrive HCV ID kit. The kit, a qualitative hepatitis C virus (HCV) diagnostic assay that is performed on Genedrive’s portable molecular diagnostics platform, delivers results in 90 minutes. Under the terms of this agreement, FIND was expected to lead evaluation studies of Genedrive’s test in Cameroon and the country of Georgia from September 2018 through May 2019. These studies are intended to assess the diagnostic accuracy of Genedrive HCV ID across diverse genotypes, as well as the test’s usability in the limited-resource settings for which it is designed. The studies will also feed into FIND’s broader efforts as the lead partner on a multi-year, multi-country HCV project intended to support the development of simple point-of-care HCV diagnostic tools that can be made widely available.

Natera, Fox Chase Cancer Center to Study ctDNA Assay for Kidney Cancer

Natera and Fox Chase Cancer Center have partnered to assess Natera’s Signatera customized circulating tumor DNA (ctDNA) assay for monitoring recurrence of kidney cancer. The study will analyze biological specimens collected and banked from 49 patients diagnosed with kidney cancer, including one group whose cancer recurred and another that did not experience recurrence after 3 years or more. The study will use Signatera—currently a research-use only assay—as well as next-generation sequencing technology to determine whether Signatera distinguishes between the recurring and non-recurring kidney cancer cases. “There is a paucity of data for [ctDNA] in kidney cancer,” said Philip Abbosh, MD, PhD, an assistant professor at the Fox Chase Cancer Center and study lead. “Determining the relationship between kidney cancer genetic profiles and prognosis, including recurrence, using the Signatera assay has great potential to improve patient care by detecting cancer recurrence earlier, assisting adjuvant therapy decision-making, determining treatment effects, and assessing the need for intervention during follow-up.”

Tecan to Buy NuGen Technologies

The Switzerland-based Tecan Group has entered an agreement to acquire NuGen Technologies for $54.5 million with the goal of expanding Tecan’s offerings to include next-generation sequencing (NGS) reagents. Under the terms of the acquisition, NuGen will become part of Tecan’s Life Sciences Business. NuGen provides NGS and microarray sample preparation solutions for a broad range of specimen types including RNA and DNA from whole tissues, formalin-fixed paraffin-embedded tissue samples, and single cells from blood samples. By combining NuGen’s products with its own automated workstations, Tecan aims to offer complete solutions for NGS library preparation that include dedicated workstations, accompanying consumables, and differentiated NGS reagents. “NuGen’s innovative NGS kits and genomic sample preparation solutions are an excellent complement to our industry-leading automated workstations for genomic applications,” said David Martyr, PhD, CEO of Tecan. “Through this acquisition, we are accelerating our broad genomics strategy and further increasing our recurring revenues.”

Diagenode Acquires Epigenetics Service Provider

Diagenode has bought Nxt-Dx in the hopes that this acquisition will broaden the company’s role in epigenetic biomarker discovery. Based in Belgium, Nxt-Dx provides a broad range of epigenetics services, including targeted DNA methylation assays that use pyrosequencing or next-generation sequencing and Illumina’s Infinium Methylation Epic array. These technologies are designed to enable more targeted screening of DNA methylation biomarkers. In addition, Nxt-Dx offers chromatin and messenger RNA wet-lab and analysis services. “The services offered by Nxt-Dx perfectly complement Diagenode’s current chromatin, RNA, and DNA methylation assay services and will allow researchers to focus both on discovery and validation of epigenetic signatures,” said Didier Allaer, CEO of Diagenode. “Additionally, the targeted DNA methylation analyses that Nxt-Dx offers now close the gap between epigenetics and [in vitro diagnostic] assay development.”

Sotera Health Buys Gibraltar Laboratories

Sotera Health has acquired New Jersey-based Gibraltar Laboratories, thereby expanding the U.S.-based analytical testing capabilities of Sotera Health’s Nelson Labs business. Gibraltar Laboratories provides microbiology and analytical chemistry testing, as well as sterility assurance, for medical device and pharmaceutical manufacturers. Its facilities are Food and Drug Administration-registered and ISO 17025-accredited. Sotera expects this acquisition to enhance Nelson Labs’ offerings, which include microbiological testing, analytical testing, and expert advisory services to assist customers in developing and maintaining sterilization solutions in medical devices, as well as in tissue/implantable products and the pharmaceutical and biologics fields. “Gibraltar’s offerings and the strategic location of its facilities will be a great benefit to our mutual customers,” said Jeff Nelson, president of Nelson Labs. “The Gibraltar team … has an excellent reputation for designing specialized studies that help manufacturers prove the safety, efficacy, and regulatory compliance of their products.”