Twist Bioscience Launches Rapid Turnaround, Customizable Panels to Advance R&D in Minimal Residual Disease (MRD) Detection in Cancer Screening

On June 7, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist MRD Rapid 500 Panel1, a custom solution that can be added to a standard next generation sequencing (NGS) workflow, offering fully customizable and highly cost effective panels to detect minimal residual disease (MRD) in as few as five days (Press release, Twist Bioscience, JUN 7, 2022, View Source [SID1234615719]).

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Twist’s customers develop MRD tests that can be used in a variety of ways for patients with cancer. MRD testing is a non-invasive method for tracking and predicting cancer progression over time, using simple blood draws to track low levels of circulating tumor DNA (ctDNA) in the blood. MRD testing can be used during cancer treatment to determine if there are tumor cells remaining and to assess whether a treatment plan needs to be adjusted. This testing can also be used after a patient achieves remission to monitor for recurrence of cancer cells.

"When it comes to monitoring minimal residual disease, which can inform treatment options for patients with cancer, there is no time to waste. With the Twist MRD Rapid 500 Panel, we are able to rapidly create custom panels for our research customers, including panels specific to each sample’s unique genetic variance of cancer in as few as five days," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "MRD is becoming the gold standard for monitoring cancer and informing personalized treatments for patients. Through this panel, we facilitate the research and development of our customers in developing new MRD solutions that clinicians can use to benefit their patients."

The Twist MRD Rapid 500 Panel can be incorporated into a standard NGS workflow and applies hybrid capture technology to sequence specific regions that may provide customized disease insights to researchers. This technology provides broader coverage than PCR or amplicon sequencing methods, potentially improving sequencing sensitivity and expands utility.

To develop the custom panels, Twist receives targets of interest that have been identified by the customer through sequencing specific tumor cells. Twist then designs the probe sequence in a single day, manufactures and ships the panel in five business days, drastically reducing the waiting period typical of custom products and enabling quick response times. The Twist MRD Rapid 500 Panel leverages Twist’s existing protocols for target enrichment, allowing it to be performed simultaneously with established Twist whole exome NGS workflows.

About Twist MRD Rapid 500 Panel

The Twist MRD Rapid 500 Panel is the latest product in Twist’s expanding portfolio of research use only sequencing products dedicated to improving the performance and accessibility of research tools for advancing R&D in oncology solutions. Paired with Twist’s cfDNA pan cancer reference standards, UMI adapter system, and leading Exome 2.0 product line, the Twist MRD Rapid 500 Panels bridge the gap between costly comprehensive sample screening and small fixed content tests.

Thermo Fisher Scientific Updates Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to Comply with IVDR Regulations

On June 7, 2022 To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific reported that it is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally (Press release, Thermo Fisher Scientific, JUN 7, 2022, View Source [SID1234615718]). The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.

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Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.

"Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations," said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. "We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows."

Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.

The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA).

Exscientia to Present at the Goldman Sachs 43rd Annual Global Healthcare Conference

On June 7, 2022 Exscientia (Nasdaq: EXAI) reported that Andrew Hopkins, DPhil., Exscientia’s founder and CEO, and Dave Hallett, Chief Operations Officer, will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Tuesday, June 14, 2022 at 9:20 a.m. P.T. (5:20 p.m. BST) (Press release, Exscientia, JUN 7, 2022, View Source [SID1234615716]).

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A live webcast of the fireside chat will be available on the Company’s website, under the "Investors & Media" section at www.investors.exscientia.ai. An archived replay of the webcast will be available for approximately 30 days following the presentation.

CEL-SCI Presents Phase 3 Multikine Head & Neck Cancer Data at ASCO

On June 7, 2022 CEL-SCI Corporation (NYSE American: CVM) reported that its abstract and poster titled "Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study" was presented on June 6, 2022 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Cel-Sci, JUN 7, 2022, View Source [SID1234615715]).

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Presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., to the largest gathering of cancer experts from academia, industry, patient advocacy and policy, the poster provided detailed data on Multikine’s (Leukocyte Interleukin, Inj.)* efficacy in extending overall survival in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck. The abstract was selected by ASCO (Free ASCO Whitepaper) for poster presentation and was well received by oncology experts at the conference.

Based on the results of this pivotal Phase 3 study, including data in the ASCO (Free ASCO Whitepaper) poster presentation, CEL-SCI intends to file a Biologic License Application with the U.S. Food and Drug Administration (FDA) for approval of this indication.

Link to poster: View Source

Link to ASCO (Free ASCO Whitepaper) abstract 6032: View Source

The conclusions presented in the poster are as follows:

Safety results were not significantly different between treatment groups.
Leukocyte Interleukin, LI (MK) neoadjuvant immunotherapy did not add excess safety issues or TEAEs.
In the Randomized ITT population, early LI (MK) response decreases mortality and is prognostic/predictive of OS.
ITT Lower Risk LI (MK)+CIZ+SOC absolute OS advantage over SOC alone (Control) increased over time to 14.1% at 5-years; the 0.68 HR corresponds to a 47% prolongation of median survival, having a 46-month median OS advantage over SOC alone. The SCCHN population studied has been without any new therapy options in decades.

Repare Therapeutics to Participate at the Goldman Sachs 43rd Annual Global Healthcare Conference

On June 7, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Tuesday, June 14, 2022 at 03:20 p.m. Pacific Time/ 6:20 p.m. Eastern Time in Rancho Palos Verdes, CA (Press release, Repare Therapeutics, JUN 7, 2022, View Source [SID1234615714]).

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A live webcast of the fireside chat can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days.