Day: June 6, 2022

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)– Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will present seven posters derived from the company’s FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

One of Agendia’s posters, selected for the oral discussion session, titled Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint [Reid, S., et al.], will present findings from a racially-diverse cohort and resulting transcriptomic analyses suggesting hormone receptor-positive (HR+)/Basal tumors are biologically similar to triple-negative breast cancer (TNBC) tumors, regardless of race, demonstrating the importance of subtyping a tumor’s biology to determine optimal treatment course. BluePrint® also identified racial disparities in the proportion of HR+/Basal tumors, showing a near doubling of such tumors among Black women, underscoring the need for diverse representation in clinical trials, a hallmark of the FLEX Trial.

“Leveraging the BluePrint assay, we are able to uncover new gene expression insights for HR+/Basal breast cancer tumors, which traditionally are more aggressive, higher grade, and disproportionally impact Black women compared to White women,” said Sonya Reid, MD, MPH, Department of Medicine, Vanderbilt University Medical Center. “The FLEX Trial’s robust collection of diverse patient genomic profiles uniquely allows for sub-studies analyses like these to take place, helping researchers better support their patients from all racial and ethnic backgrounds with further classification of breast cancer tumors.”

These data build on findings presented at San Antonio Breast Cancer Symposium 2021, also authored by Dr. Reid, that showed MammaPrint® and BluePrint® more robustly identify differences in more aggressive breast cancers in Black and White women beyond clinical factors, highlighting the fundamental importance of genomic classification and personalized treatment planning.

In addition, Agendia will present several sub-studies highlighting the FLEX Trial’s approach to cancer research by accelerating impactful data generation, aimed at redefining cancer care. The company believes this patient-centric design and national network of participating sites backed by Agendia will allow its investigator-initiated sub-studies to produce important results with the potential to drive science forward, like those being shared at ASCO 2022:

Clinical implications for patients with discordant Oncotype and MammaPrint results [Socoteanu, M., et al.] recalls findings from the IMPACT trial, which demonstrated MammaPrint and BluePrint inform treatment planning and increase physician confidence. In an effort to examine consistency among genomic tests, researchers analyzed therapy implications for patients who received both results from MammaPrint and BluePrint as well as OncotypeDx within the FLEX Trial:

Of 722 patients, 49% were observed to have discordant results with the potential of negative clinical impact. This includes 27% who may be undertreated, 6% potentially overtreated, and 10% who may not be given the option to decrease endocrine therapy to two years based on MammaPrint Ultra Low genomic risk assessment. Of 114 concordant MammaPrint High Risk tumors, 14% were genomically classified as Basal, and likely require more aggressive chemo than typically used in estrogen receptor-positive (ER+) breast cancers.

Together, these analyses showed more than half the patients in this cohort were at potential risk for undertreatment or overtreatment, had they received an OncotypeDx test as a standalone test. Discordance between OncotypeDx Recurrence Scores and MammaPrint with BluePrint results, most often yields the potential for undertreatment if the Recurrence Score is relied upon for treatment decision-making, putting a significant amount of risk on the patient since undertreatment may result in an incurable metastatic recurrence.

Whole transcriptome analysis of tumors with discordant Oncotype and MammaPrint results in the FLEX trial [Socoteanu, M., et al.] also looked at the differences in quality of results from OncotypeDx Recurrence Scores in comparison to MammaPrint results, this time by evaluating the genomic diversity within each test’s classification. The analysis found a high amount of genomic diversity within the OncotypeDx Recurrence Score Intermediate group, while conversely showing MammaPrint further classifies cases into more genomically rich and distinct categories, allowing for more precise treatment pathways based on the individual tumor.

Investigation of a genomic signature for transcription factor MAF gene amplification and lack of bisphosphonate benefit in early breast cancer [Nasrazadani, A. et al.] provides whole transcriptome analyses suggesting breast cancer tumors with mesenchymal aponeurotic fibrosarcoma (MAF) gene amplifications – a biomarker associated with shortened survival and lack of bisphosphate benefit when related to bone metastases in breast cancer – may be identified by a unique gene expression pattern. In this study, researchers used the MammaPrint/BluePrint platform to identify a set of 57 genes that could potentially predict MAF amplification status which could enable a woman’s care team to potentially anticipate a lack of benefit from adjuvant bisphosphonate treatment. Additionally, these results show mining the complete genome more thoroughly provides expanded insights and can shed light on new biomarkers previously unknown.

Distribution of breast cancer molecular subtypes within receptor classifications: Lessons from the I-SPY2 trial and FLEX Registry [Cha, J., et al.] proposes that the breast cancer research community drive science forward and work with the NCI’s Surveillance, Epidemiology, and End Results (SEER) Program to update its immunohistochemical (IHC) labels to avoid overlap with molecular subtype nomenclature and incorporate more modern classifications when available. Study results show the SEER Program database using IHC labels is not accurately identifying genomic subtypes via its annotations. In fact, the categorizations in the population-based registry were discordant with MammaPrint and BluePrint results in 52% of I-SPY2 Trial cases and 43% of FLEX Trial cases, emphasizing the growing importance of molecular subtyping to inform treatment and epidemiological research.

Defining transcriptomic profiles of early-stage mucinous breast cancers: A FLEX sub study [Sivapiragasam, A., et al.] revealed although mucinous breast cancer (MuBC), a rare subtype of invasive ductal carcinoma (IDC) accounts for less than 2% of all breast cancers, it often is expected to have low clinical risk and a favorable prognosis, however new genomic testing showed half of the patients observed in the study were in fact classified as MammaPrint High Risk. Through the examination of transcriptomic profiles, the findings demonstrated MammaPrint Low Risk MuBC is biologically different from MammaPrint Low Risk IDC providing new evidence as to why there are more favorable prognoses. Results also indicated MammaPrint High Risk MuBC and High Risk IDCs are highly genomically similar and could benefit from chemotherapy, providing additional clarity to guide specific treatment among these breast cancer subtypes.

FLEX, the 30,000 breast cancer transcriptome project: A platform for early breast cancer research using full-genome arrays paired with clinical data [Ma, C., et al.] shares data from the 38 investigator-initiated sub-studies – including five investigating racial disparities – approved within the FLEX Real World Evidence Trial (NCT03053193). Since the trial’s inception in 2017, FLEX has enrolled 10,000 patients at over 109 sites with a diverse data set designed to meet the needs of historically under-represented patients with breast cancer.

“These new findings presented at ASCO 2022 show the breadth of the FLEX research platform to identify and evaluate the many different complexities of a breast cancer biology at diagnosis that may facilitate more precise and individualized treatment recommendations,” said William Audeh, MD, Chief Medical Officer at Agendia. “Agendia’s commitment to expanding our understanding of breast cancer to improve outcomes for women with breast cancer is astounding, exemplified by the FLEX Real World Evidence Trial. FLEX has the significant potential to broaden the application of genomic information through assays such as MammaPrint, BluePrint, and new proprietary Agendia signatures, which could lead to practice-changing models within breast cancer care aimed at improved outcomes for women with breast cancer.”

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

Source: Cyprus News Agency

The plenary session of the European Parliament in Strasbourg begins on Monday.

The European Commission’s annual report on Turkey, whose accession negotiations have stalled since 2018, will be discussed by the MEPs during the first day of deliberations. On the same day, issues such as the EU and security issues in the region will also be discussed. EU and the Indopacific, EU islands and cohesion policy, the EEAS roadmap for climate change and defense, Article 17 of the Common Fisheries Policy Regulation will also be on the agenda, while the 60th anniversary of the Common Agricultural Policy (CAP) will be celebrated.

On the second day (June 7), the fight against climate change through a drastic reduction in greenhouse gas emissions, as well as the protection of jobs and citizens will be discussed. In addition, EU foreign policy chief Josep Borrell will answer MEPs questions about the EU’s efforts to address the impact of the war in Ukraine on third countries while the President of the European Commission, Ursula von der Leyen, will respond to questions on the release of funds for the recovery of Poland, despite the continuing threats to the rule of law. MEPs are expected to demand faster implementation of the Versailles Declaration and gradual foreign policy change of the EU.

On the third day of the plenary session (June 8), the European Parliament is expected to adopt its positions on eight proposals that are part of the adjustment package aimed at reducing greenhouse gas emissions by 55% (“Fit for 55”) by 2030. It will also evaluate the conclusions of the Extraordinary European Council of 30-31 May, which agreed on a sixth package of sanctions against Russia for its attack on Ukraine.

In addition, the Speaker of the Parliament of Ukraine, Ruslan Stefanchuk, will address in person during a solemn sitting in the plenary chamber. At the same time, MEPs will discuss the future and prospects of the EU with the Irish Taoiseach, Micheál Martin. They are also expected to condemn the regression of women’s sexual and reproductive health rights in the US and worldwide, calling for safe access to abortion.

In another development, the winner of the European Film Award LUX 2022 will be announced in the Semicircle of the European Parliament.

During the third day, issues such as Parliament’s right of initiative, the EU-Mauritania Sustainable Fisheries Partnership Agreement and its implementation protocol, violations of human rights, democracy and the rule of law in Xinjiang and Nicaragua, as well as the entry of registrations in the Schengen Information System (SIS) will also be discussed.

On the last day of plenary (9 June), MEPs are expected to call for a first set of concrete changes to the EU’s fundamental texts, meeting citizens’ expectations, and to vote in favour of the new instrument for international public procurement created to promote the opening of world markets. In addition, they will discuss a new trade instrument for banning products produced by forced labour.

Source: Cyprus News Agency

Italian MP, Piero Fassino, rapporteur of the subject “Call for return of Ammochostos to its lawful residents” in the Committee on Political Affairs and Democracy of the Parliamentary Assembly of the Council of Europe (PACE), begins a working visit to Cyprus until 8 June.

Fassino is accompanied by the Secretary of the Committee, an announcement by the House of Representatives says.

During his visit to Cyprus, he will be received by House President, Annita Demetriou, and he is expected to meet with the heads or representatives of parliamentary parties, the President of the House Committee on Foreign and European Affairs, Harris Georgiades, the head and members of the Cypriot delegation to PACE, Nicos Tornaritis, Giorgos Loukaides and Christiana Erotocritou, as well as with Attorney General, Giorgos Savvides, the Minister of Foreign Affairs, Ioannis Kasoulides, and the Mayor and the Municipal Council of Ammochostos, in Deryneia.

He will also attend meetings with the Special Representative of the UN in Cyprus, Colin Stewart, and the head of the European Commission in Cyprus, Myrto Zambartas, while a dinner with ambassadors of EU member-states is also in his schedule.

A PACE press release said that Fassino will also travel to the “northern part of the island” to meet in the Turkish-occupied areas with representatives of the Turkish Cypriot community and visit Varosha (part of Famagusta).

Cyprus has been divided since 1974, when Turkey invaded and occupied its northern third. Varosha, the fenced off section of the Turkish occupied town of Famagusta, is often described as a “ghost town”.

UN Security Council resolution 550 (1984) considers any attempts to settle any part of Varosha by people other than its inhabitants as inadmissible and calls for the transfer of this area to the administration of the UN. UN Security Council resolution 789 (1992) also urges that with a view to the implementation of resolution 550 (1984), the area at present under the control of the United Nations Peace-keeping Force in Cyprus be extended to include Varosha.

Turkish Cypriot leader, Ersin Tatar, announced in July 2021 a partial lifting of the military status in Varosha. On October 8, 2020, the Turkish side opened part of the fenced area of Varosha, following an announcement made in Ankara on October 6. Both the UN Secretary-General and the EU expressed concern, while the UN Security Council called for the reversal of this course of action. In his latest report to the Security Council, UN Secretary-General Guterres underlines the importance of adhering fully to UN resolutions, underscoring that the position of the United Nations on this matter “remains unchanged.”

Source: Cyprus News Agency

The EU should have a more active role and exert pressure on Turkey to terminate its hostile attitude and focus on its European course Cypriot MP ?arris Georgiades, Chair of the Foreign affairs committee told Piero Fassino, rapporteur for Famagusta of the Parliamentary Assembly of the Council of Europe to whom he noted the need for a more active role of the EU towards Ankara.

In a meeting on Monday, in Nicosia, the two men discussed the latest provocations of Turkey in Varosha, the fenced-off part of the city of Famagusta, as well as the provocative actions in Cyprus’ exclusive economic zone. Georgiades noted that Varosha need to be returned to its lawful residents as the UN resolutions dictate.

He also referred to the Confidence Building Measures (CBMs) the President of the Republic put on the table which could facilitate the resumption of talks.

He also said that EU should exert pressure to Turkey to terminate its hostile attitude and to focus on its European course.

Georgiades also said that the provocations in the EEZ violate the international law.

Cyprus has been divided since 1974, when Turkey invaded and occupied its northern third. Varosha, the fenced off section of the Turkish occupied town of Famagusta, is often described as a “ghost town”.

UN Security Council resolution 550 (1984) considers any attempts to settle any part of Varosha by people other than its inhabitants as inadmissible and calls for the transfer of this area to the administration of the UN. UN Security Council resolution 789 (1992) also urges that with a view to the implementation of resolution 550 (1984), the area at present under the control of the United Nations Peace-keeping Force in Cyprus be extended to include Varosha.

Source: Cyprus News Agency

The level of human rights in Turkey is “pathetic”, the rapporteur of the European Parliament’s report on Turkey, Nacho Sanchez Amor, said during a debate on the report on the first day of the European Parliament plenary session in Strasbourg on Monday.

He also spoke of “deliberate regression from the previous situation”. “I do not believe that Turkey ‘s accession negotiations will survive for the next five years,” he said, adding that the unpredictability of Turkish behaviour is leading Turkey to isolation.

European Vicinity and Enlargement Commissioner Oliver Varheli (who replaced EU High Representative for Foreign Affairs and Security Policy Josep Borrell) said Turkey is still moving away from the EU, adding the European Commission worries about the rule of law and human rights in Turkey and that it will continue to support civil society and democracy in the country.

Varheli also pointed out that the biggest challenge is the unresolved Cyprus issue and called on Turkey to stop provocations in Varosha and return to dialogue. “We call on Turkey to side with the EU on sanctions imposed on Russia,” he said. “Turkey is a key partner, but we cannot justify its setbacks,” he added.

On behalf of the European People’s Party, Georgy Vlad Nistor stated that Ankara is playing a diplomatic and political game and that its actions against Cyprus and Greece “are beyond imagination”.

On behalf of the Group of the Progressive Alliance of Socialists and Democrats in the EP, Maria Arena stressed that 87 journalists are imprisoned in Turkey and that students protesting in favour of LGBTQI rights are arrested. “Turkey is not in line with European democratic principles,” she said.

On behalf of the Renew Europe Group, Malik Azmani pointed out that things will get worse as we approach the elections in Turkey. A red line is the Turkish veto to Sweden and Finland from joining NATO, he said, adding that Turkey should not become a tax haven for Russia’s economic interests.

On behalf of the Group of the Greens, Sergei Lagodinsky raised the issue of Turkey’s credibility as a defense partner. In addition, he noted that Turkey’s attitude towards Sweden and Finland is a “solidarity issue”, while he also spoke about Turkey’s aggressive attitude towards EU member states. “We are slowly losing faith in Turkey’s European future,” he added.

On behalf of the Identity and Democracy Group, Nikolaus Fest stressed that things are getting worse for Turkey. At the same time, he raised the question of what else is needed to draw the right conclusions. He also called for a halt to Turkey’s accession talks while Erdogan is in power.

On behalf of the group of European Conservatives and Reformists, Emmanuel Frangos described Turkey as an “extremist state” and suggested that the policy of equal distances is a bomb in the foundations of Europe.

Interventions by the Cypriot MEPs

———————————————-

On behalf of the Left Group in the European Parliament, George Georgiou said that some Europeans pretend to see light in the tunnel of Euro-Turkish relations and place Turkey on the right side of history. He also said that Turkey did in Cyprus, 48 years ago, what Russia did in Ukraine, continues to illegally occupy European territory and is operating in a revisionist manner against Greece. “Over values and law, geopolitical interests and competitions to the detriment of the peoples are paramount,” Georgiou concluded.

Lefteris Christoforou of the European People’s Party said that the EU does not tolerate any invader and should not tolerate Turkey that does not respect any EU values. The EU should not consider the invader as a strategic partner, he concluded.

Loucas Fourlas of the European People’s Party noted that Erdogan’s Turkey has nothing to do with the European edifice. “How much longer will we pretend that Turkey has a place next to democratic European societies?” he asked, adding that if we were serving values rather than interests, we would not even be discussing a progress report on Turkey today.

Demetris Papadakis of the Group of the Progressive Alliance of Socialists and Democrats in the EP said that some within the European family want to believe that Turkey respects the human rights of its citizens, does not imprison anyone who disagrees, has good relations with its neighbours, does not provoke tensions and does not occupy European territories by force. Their purpose is to serve the economic interests of their countries, he concluded.

Costas Mavrides of the Group of the Progressive Alliance of Socialists and Democrats in the EP, spoke of neo-Ottoman expansionism, indicating that the EU followed the policy of appeasement that feeds the Turkish beast. In Russia, six packages of sanctions were properly imposed, but in Turkey not one, he added. In closing, Mavrides called for a ban on arms sales to Turkey, withdrawal of Turkish troops from Cyprus, and Turkey’s denunciation to the World Trade Organization.

Source: Cyprus News Agency

Cyprus President Nicos Anastasiades has said that he will protest to the United Nations about Turkey’s recent illegal activities.

In an interview with CyBC, on Monday, Anastasiades said that a letter he will send the UN will include Turkey’s actions as regards the illegal airport in Turkish occupied Tymbou, as it has said it would consider flights originating from there as “domestic” and the financial protocol between Turkey and the illegal regime in the occupied areas through which Ankara is seeking to have absolute control over Turkish Cypriots.

Among other things, he also spoke of a blatant revisionism on the part of Turkey and expressed the view that despite dangers and threats made against both Athens and Nicosia, Turkish President Erdogan would not go ahead with desperate actions which would have unforeseeable consequences for Ankara.

Cyprus has been divided since 1974, when Turkey invaded and occupied its northern third. Varosha, the fenced off section of the Turkish occupied town of Famagusta, is often described as a “ghost town”.

UN Security Council resolution 550 (1984) considers any attempts to settle any part of Varosha by people other than its inhabitants as inadmissible and calls for the transfer of this area to the administration of the UN. UN Security Council resolution 789 (1992) also urges that with a view to the implementation of resolution 550 (1984), the area at present under the control of the United Nations Peace-keeping Force in Cyprus be extended to include Varosha.

Source: Cyprus News Agency

Cyprus in talks with other countries to set up fire combating mechanism says Environment Minister

Cyprus authorities are in talks with third countries with the aim to set up a speedy fire combating mechanism, Environment Minister Costas Kadis said on Monday replying to questions at the Presidential Palace.

Kadis said that the procedures are concluded within days for Cyprus to acquire 2 helicopters and 2 airplanes for putting out fires. He said more specifically that an agreement has reached for the airplanes and “we are very close for the helicopters.”

The Minister added that we are in contact with other countries for cooperation if needed, in cases of big fires.

Kadis also said that on Tuesday, in the framework of the ministerial meeting for climate crisis he will have contacts with ministers from countries in the region and one of the issues on the agenda will be the cooperation in cases that fire combating assistance is needed.

Source: Cyprus News Agency

Cyprus’ Defence Minister Charalambos Petrides expressed the hope on Monday that, within the coming months, agreements and cooperation programmes with the US would be finalised.

He was addressing the graduation ceremony of the 82nd School of Underwater Demolition, at the Evangelos Florakis Naval Base in Mari.

The Minister said that the underwater demolition commandos are “the spearhead” of one of the most elite National Guard Units.

He said that Cyprus needs young, responsible, disciplined people, who love their homeland. Continuous training, preparedness, and high morale are essential qualifications for the fulfillment of the mission of the Special Forces, he said.

The Minister also referred to the Cyprus problem stressing that “we must not forget who we are up against”, a country like Turkey which daily shows its intentions, and that is methodically seeking the creation of two states on the island, while it proceeds with new illegal faits accomplis in the fenced area of the occupied part of Famagusta. He also said Turkey is violating the Republic of Cyprus’ exclusive economic zone and is using the immigration crisis to facilitate the entry of thousands of migrants into the territory of the Republic, aimed at the demographic change and causing a social crisis.

We remain, however, he added, “committed and ready to start a constructive dialogue for a just settlement of the Cyprus problem on the basis of United Nations Security Council resolutions.”

“On the other hand, we are obliged to continue training, equipping our armed forces and maintaining them at high levels of preparedness,” he added.

He also said that the core of the Defence Ministry’s foreign policy is also the promotion of cooperation with other states.

Petrides referred to the Agapinor 2022 military exercise that recently took place in cooperation with Israel, and the first high-level official visit by a Defence Minister of the Republic of Cyprus at the US Pentagon and the National Security Council.

“We hope that in the coming months, agreements and cooperation programmes will be completed that will further strengthen our relations with the United States,” he said.

In his own address, Chief of the National Guard, Lieutenant General, Demokritos Zervakis, said that, after nine months of hard training, the new young frogmen will join one of the most elite units of the National Guard, the Underwater Demolition Unit.

Referring to the participation of the National Guard in international activities, the urged the newly-trained officers “to seize the opportunity” to train with other such units of other countries arguing that this would offer them great experience in their military career and contribute to the operational preparedness of their unit.

Greece’s Ambassador in Cyprus, also attended the ceremony, as did the President of the House Defence Committee, other MPs, the Commander of the Cyprus Joint Rescue Coordination Center, and the families of the new frogmen.

Source: Cyprus News Agency