GlobeNewswire

FDA grants Breakthrough Device Designation for Roche's Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients

Share
  • FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to be treated with Pfizer's investigational drug PF-06946860
  • Unintentional weight loss (cachexia) is a highly prevalent complication of cancer, affecting more than half of all cancer patients worldwide, potentially leading to significant functional impairment and increased risk of death
  • Successful cachexia treatment can potentially contribute to improved cancer treatment worldwide

Basel, 8 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their Elecsys® GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. This in vitro diagnostic immunoassay is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours for treatment with Pfizer Inc.'s (NYSE: PFE) investigational drug PF-06946860.

Cachexia is a metabolic disorder and comorbidity that occurs with several chronic diseases including cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD). It impacts more than 30 million people globally. Cachexia manifests as marked involuntary body weight loss, muscle atrophy, and reduced appetite, progressing to significant functional impairment and increased risk of death.¹ Elevated GDF-15 is associated with cachexia in cancer patients. Cachexia is a highly prevalent complication of cancer, affecting between 50 to 80% of all cancer patients. This range depends on the tumour type, the patient response to tumour progression and on individual body type.²

“We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics”, said Thomas Schinecker, CEO Roche Diagnostics. “The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships. The ability to detect elevated GDF-15 in patients who are experiencing weight loss may provide a precision-medicine approach to identifying patients likely to respond to a GDF-15 therapeutic treatment.”

About Elecsys GDF-15
Elecsys GDF-15 is a quantitative serologic, two-incubation step electrochemiluminescence immunoassay (ECLIA) using the sandwich test format for the detection of GDF-15 in human serum. The Elecsys GDF-15 assay is indicated as an aid in identifying cachectic patients 18 years of age and older with solid tumours for treatment with PF-06946860. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. GDF-15 has CE approval in several intended uses in cardiology including risk prediction of major bleeding events of atrial fibrillation patients, risk stratification of patients with acute coronary syndrome or chronic heart failure.

About Cachexia
Cachexia impacts more than 30 million people globally but is poorly understood due to its complexity. It has traditionally been seen as a complication of chronic diseases or end stages of cancer. The burden cachexia poses on patients, their caregivers and loved ones, as well as the healthcare system, is significant. Cancer cachectic patients experience numerous complications including, but not limited to, reduced effectiveness of chemotherapy, reduced mobility and reduced functionality of muscle-dependent systems, such as the respiratory and cardiovascular systems, leading to decreased quality of life and survival.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.



References
[1] Baracos et al., Cancer-associated cachexia, Nature Reviews, 2018
[2] Argilés et al. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer 2014


Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Dr. Nicolas Dunant
Phone: +41 61 687 05 17

Patrick Barth
Phone: +41 61 688 44 86
Dr. Daniel Grotzky
Phone: +41 61 688 31 10

Karsten Kleine
Phone: +41 61 682 28 31
Nina Mählitz
Phone: +41 79 327 54 74

Nathalie Meetz
Phone: +41 61 687 43 05
Dr. Barbara von Schnurbein
Phone: +41 61 687 89 67


Roche Investor Relations
Dr. Karl Mahler
Phone: +41 61 68-78503
e-mail: karl.mahler@roche.com

Jon Kaspar Bayard
Phone: +41 61 68-83894
e-mail: jon_kaspar.bayard@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Dr. Gerard Tobin
Phone: +41 61 68-72942
e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Dr. Lisa Tuomi
Phone: +1 650 467 8737
e-mail: tuomi.lisa@gene.com

Attachment


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Terranets patenterade VoxelFlow™ sensorteknologi visas upp vid STARTUP AUTOBAHN i gemensam presentation med Mercedes-Benz.25.2.2021 16:37:22 CETPressemelding

Den revolutionerande tekniken adresserar säkerhet för AV- och ADAS genom en patenterad och uppkopplad 3D-sensorteknologi. Lund, Sverige, 25 februari 2021 - Terranet AB (Terranet / företaget), (Nasdaq: TERRNT-B.ST), bakom den patenterade programvaran VoxelFlow, visade framgångsrikt upp sin revolutionerande sensorteknologi på STARTUP AUTOBAHN, i en gemensam presentation med Mercedes-Benz. VoxelFlow™ kommer kunna bidra till att autonoma fordon (AD) och fordon med avancerade förarstöd (ADAS) blixtsnabbt och precist kan förstå och definiera en levande varelse i en radie på upp till 40 meter runt bilen, det område där flest olyckor sker. På STARTUP AUTOBAHN visade Terranet hur 3D-tekniken, VoxelFlow ™ skannar av ett område och reagerar på tre millisekunder. I det gemensamma projektet mellan Mercedes-Benz och Terranet matas VoxelFlow ™ sensordata in i ett säkerhetslager för Mercedes-Benz navigationssystem "LiveMap", som därmed kan uppdateras i realtid. Tillsammans kan de två teknikerna uppfat

Suominen Corporation – Manager’s transaction: Kelly, Lynda25.2.2021 15:30:00 CETPress release

Suominen Corporation February 25, 2021 at 4:30p.m. (EEST) Suominen Corporation - Managers' Transactions ____________________________________________ Person subject to the notification requirement Name: Kelly, Lynda Position: Other senior manager Issuer: Suominen Corporation LEI: 743700Z1BNFYR9PRDF52 Notification type: INITIAL NOTIFICATION Reference number: 743700Z1BNFYR9PRDF52_20210225084219_2 ____________________________________________ Transaction date: 2021-02-25 Venue: OFF-EXCHANGE TRANSACTIONS (XOFF) Instrument type: SHARE ISIN: FI0009010862 Nature of the transaction: RECEIPT OF A SHARE-BASED INCENTIVE OR REMUNERATION Transaction details (1): Volume: 5,536 Unit price: N/A Aggregated transactions (1): Volume: 5,536 Volume weighted average price: N/A SUOMINEN CORPORATION For more information, please contact Emilia Peltola, Vice President, Communications & IR, Suominen Corporation, tel. +358 50 540 9747 Suominen manufactures nonwovens as roll goods for wipes and other applications. O

Suominen Corporation – Manager’s transaction: Saïm, Mimoun25.2.2021 15:30:00 CETPress release

Suominen Corporation February 25, 2021 at 4:30 p.m. (EEST) Suominen Corporation - Managers' Transactions ____________________________________________ Person subject to the notification requirement Name: Saim, Mimoun Position: Other senior manager Issuer: Suominen Corporation LEI: 743700Z1BNFYR9PRDF52 Notification type: INITIAL NOTIFICATION Reference number: 743700Z1BNFYR9PRDF52_20210225082607_2 ____________________________________________ Transaction date: 2021-02-25 Venue: OFF-EXCHANGE TRANSACTIONS (XOFF) Instrument type: SHARE ISIN: FI0009010862 Nature of the transaction: RECEIPT OF A SHARE-BASED INCENTIVE OR REMUNERATION Transaction details (1): Volume: 5,387 Unit price: N/A Aggregated transactions (1): Volume: 5,387 Volume weighted average price: N/A SUOMINEN CORPORATION For more information, please contact Emilia Peltola, Vice President, Communications & IR, Suominen Corporation, tel. +358 50 540 9747 Suominen manufactures nonwovens as roll goods for wipes and other applications.

Suominen Corporation – Manager’s transaction: Koivisto, Markku25.2.2021 15:30:00 CETPress release

Suominen Corporation February 25, 2021 at 4:30p.m. (EEST) Suominen Corporation - Managers' Transactions ____________________________________________ Person subject to the notification requirement Name: Koivisto, Markku Position: Other senior manager Issuer: Suominen Corporation LEI: 743700Z1BNFYR9PRDF52 Notification type: INITIAL NOTIFICATION Reference number: 743700Z1BNFYR9PRDF52_20210225083328_2 ____________________________________________ Transaction date: 2021-02-25 Venue: OFF-EXCHANGE TRANSACTIONS (XOFF) Instrument type: SHARE ISIN: FI0009010862 Nature of the transaction: RECEIPT OF A SHARE-BASED INCENTIVE OR REMUNERATION Transaction details (1): Volume: 3,819 Unit price: N/A Aggregated transactions (1): Volume: 3,819 Volume weighted average price: N/A ‘ SUOMINEN CORPORATION For more information, please contact Emilia Peltola, Vice President, Communications & IR, Suominen Corporation, tel. +358 50 540 9747 Suominen manufactures nonwovens as roll goods for wipes and other applicati

Suominen Corporation – Manager’s transaction: Helsky, Petri25.2.2021 15:30:00 CETPress release

Suominen Corporation February 25, 2021 at 4:30p.m. (EEST) Suominen Corporation - Managers' Transactions ____________________________________________ Person subject to the notification requirement Name: Helsky, Petri Position: Chief Executive Officer Issuer: Suominen Corporation LEI: 743700Z1BNFYR9PRDF52 Notification type: INITIAL NOTIFICATION Reference number: 743700Z1BNFYR9PRDF52_20210225081652_2 ____________________________________________ Transaction date: 2021-02-25 Venue: OFF-EXCHANGE TRANSACTIONS (XOFF) Instrument type: SHARE ISIN: FI0009010862 Nature of the transaction: RECEIPT OF A SHARE-BASED INCENTIVE OR REMUNERATION Transaction details (1): Volume: 12,002 Unit price: N/A Aggregated transactions (1): Volume: 12,002 Volume weighted average price: N/A SUOMINEN CORPORATION For more information, please contact Emilia Peltola, Vice President, Communications & IR, Suominen Corporation, tel. +358 50 540 9747 Suominen manufactures nonwovens as roll goods for wipes and other applicati

Suominen Corporation’s conveyance of own shares based on the long-term share-based incentive plan25.2.2021 15:00:00 CETPress release

Suominen Corporation's stock exchange release on February 25, 2021, at 4 p.m. EET A total of 34,872 of Suominen Corporation's treasury shares have been conveyed without consideration to 13 key employees from the performance period 2018-2020 in accordance with the terms and conditions of the share-based incentive plan. The directed share issue is based on an authorization given by the Annual General Meeting held on March 19, 2020. Following the directed share issue on February 25, 2021, the company holds a total of 656,006 treasury shares. The share-based incentive plan was announced in the stock exchange release published on December 11, 2017. Suominen Corporation For additional information, please contact Klaus Korhonen, SVP, HR & Legal, tel. +358 10 214 3070 Suominen manufactures nonwovens as roll goods for wipes and other applications. Our vision is to be the frontrunner for nonwovens innovation and sustainability. The end products made of Suominen’s nonwovens are present in people’