Oncotype (Denmark)

Exact Sciences Presents Multiple Studies at San Antonio Breast Cancer Symposium Supporting Optimization and Individualization of Therapy for Breast Cancer Patients

Retrieved on: 
Friday, December 1, 2023
BRCA1, HR, PALB2, Magnetic resonance imaging, Nottingham Prognostic Index, Woman, Research, Prevalence, Gene, ICI, Breast cancer, Cancer, DS, Risk, Disease, Epistasis, Patient, Tumor microenvironment, DCIS, Exact sciences, Ductal carcinoma, Gene expression, Genetic testing, Messenger, BRCA2, NPI, HER2, MammaPrint, Oncotype (Denmark), Medicine, Biomarker, ERBB2, Summary, Neoplasm, Recurrence, Clinical, TNBC, Medical imaging, Birth control, Vaccine, MD

"Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients.

Key Points: 
  • "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients.
  • In cooperation with several leading breast cancer research organizations, Exact Sciences will present late-breaking data and a study included in the SABCS press program.
  • Results from Puerto Rico will also detail germline findings for a cohort of women, most of whom had a personal or familial history of breast cancer.
  • Exact Sciences will also host a discussion about the Oncotype DX Breast Recurrence Score test and the RSClin® Tool.

Exact Sciences Presents Multiple Studies at San Antonio Breast Cancer Symposium Supporting Optimization and Individualization of Therapy for Breast Cancer Patients

Retrieved on: 
Thursday, November 30, 2023
BRCA1, HR, PALB2, Magnetic resonance imaging, Nottingham Prognostic Index, Woman, Research, Prevalence, Gene, ICI, Breast cancer, Cancer, DS, Risk, Disease, Epistasis, Patient, Tumor microenvironment, DCIS, Exact sciences, Ductal carcinoma, Gene expression, Genetic testing, Messenger, BRCA2, NPI, HER2, MammaPrint, Oncotype (Denmark), Medicine, Biomarker, ERBB2, Summary, Neoplasm, Recurrence, Clinical, TNBC, Medical imaging, Birth control, Vaccine, MD

"Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients.

Key Points: 
  • "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients.
  • In cooperation with several leading breast cancer research organizations, Exact Sciences will present late-breaking data and a study included in the SABCS press program.
  • Results from Puerto Rico will also detail germline findings for a cohort of women, most of whom had a personal or familial history of breast cancer.
  • Exact Sciences will also host a discussion about the Oncotype DX Breast Recurrence Score test and the RSClin® Tool.

MDxHealth Reports Results for the Third Quarter and Nine-Month Period Ended September 30, 2023

Retrieved on: 
Wednesday, November 8, 2023
Insurance, Q&A, Operating cost, Exact sciences, GPS, Medicare, Earnout, Prostate cancer, Acquisition, Transaction, Cigna, American depositary receipt, Oncotype (Denmark), ADS, Brussels Stock Exchange, Clothing, Health care, Pharmaceutical industry, Security (finance), Health insurance, Select

Results for the three months ended September 30, 2023

Key Points: 
  • Results for the three months ended September 30, 2023
    Revenue increased 73% to $19.3 million compared to $11.2 million for the prior year.
  • Excluding GPS, revenue increased 45% to $11.3 million compared to $7.8 million for the prior year.
  • Gross profit increased 102% to $12.6 million compared to $6.2 million for the prior year.
  • Results for the nine months ended September 30, 2023
    Revenue increased 110% to $50.8 million compared to $24.2 million for the prior year.

Mdxhealth's New Share Capital Amount and New Number of Shares

Retrieved on: 
Friday, October 20, 2023
Leymus innovatus, Genomics, Disclosure, Acquisition, Genomic Health, American depositary receipt, Oncotype (Denmark), ADS, EUR, USD, Article, Security (finance)

IRVINE, CA, and HERSTAL, BELGIUM – October 20, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH) ("mdxhealth" or the "Company"), a commercial-stage precision diagnostics company, today a announces, in accordance with Article 15 of the Belgian Act of May 2, 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions, that in the context of a capital increase completed on October 20, 2023, the Company's share capital has increased from EUR 163,471,629.58 to EUR 164,302,752.89 and the number of issued and outstanding shares has increased from 270,380,936 to 272,880,936 ordinary shares, through the issuance of a total of 2,500,000 new shares.

Key Points: 
  • IRVINE, CA, and HERSTAL, BELGIUM – October 20, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH) ("mdxhealth" or the "Company"), a commercial-stage precision diagnostics company, today a announces, in accordance with Article 15 of the Belgian Act of May 2, 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions, that in the context of a capital increase completed on October 20, 2023, the Company's share capital has increased from EUR 163,471,629.58 to EUR 164,302,752.89 and the number of issued and outstanding shares has increased from 270,380,936 to 272,880,936 ordinary shares, through the issuance of a total of 2,500,000 new shares.
  • The new shares were issued pursuant to the amendment, announced on August 23, 2023, to the asset purchase agreement for the acquisition by the Company of the Oncotype DX® GPS (Genomic Prostate Score®) test from Genomic Health, Inc. (a subsidiary of Exact Sciences Corporation).
  • In addition to the outstanding shares of the Company:
    a total of 18,560,124 subscription rights of the Company are outstanding, which entitles their holders (assuming all subscription rights are granted and exercised) to subscribe to a total of 18,560,124 new shares with voting rights; and
    under the loan and security agreement entered into by the Company and Innovatus Capital Partners in August 2022, Innovatus has the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans (by means of a contribution in kind of the relevant payables due by the Company under the loans) into American Depositary Shares ("ADSs") of the Company (each representing 10 ordinary shares of the Company) at a conversion price per ADS equal to USD 11.21 (i.e., USD 1.121 per share on the basis of the ratio of 1 ADS per 10 shares).

MDxHealth Reports Q2 and Half Year 2023 Results

Retrieved on: 
Wednesday, August 23, 2023
Earnout, Cigna, Operating cost, Insurance, Medicare, GPS, ADS, Oncotype (Denmark), Prostate cancer, Q&A, Exact sciences, Video game, Select

Total revenue for the first half of 2023 was $31.4 million, an increase of 142% as compared to total revenue of $13.0 million for the first half of 2022.

Key Points: 
  • Total revenue for the first half of 2023 was $31.4 million, an increase of 142% as compared to total revenue of $13.0 million for the first half of 2022.
  • Excluding the GPS revenues, total revenues for the first half were $17.4 million, an increase of 34% compared to the first half of 2022.
  • Operating expenses for the first half of 2023 were $35.2 million, up 54% from $22.8 million for H1-2022, primarily related to the additional field sales personnel associated with the GPS business.
  • In addition, on August 9, 2023, mdxhealth announced that Cigna expanded commercial and Medicare Advantage coverage to include the Company’s Select mdx for Prostate Cancer test.

Exact Sciences Presents New Long-Term Patient Outcomes in Multi-Cancer Early Detection and Breast Cancer Recurrence Testing at ASCO® 2023

Retrieved on: 
Friday, May 26, 2023
IDC, Survivor, Abstract, American Society of Clinical Oncology, CMS, Cancer, Oncotype (Denmark), Exact sciences, ASCO, Incidence, Medicine, MD, Patient, Colorectal cancer, Risk, Lymph, Blood, Surveillance, Annual general meeting, RS, SEER, Science, Mortality, Exact Sciences (company), Recurrence, Society, Invasive carcinoma of no special type, Breast cancer, Disease, ILC, Medical imaging, Liquor, Pharmaceutical industry, Epidemiology

"These first-ever, long-term MCED follow-up data confirm Exact Sciences' approach to detecting multiple cancers at earlier stages of disease, and show that early detection enables successful treatment and long-term freedom from cancer in patients," said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences.

Key Points: 
  • "These first-ever, long-term MCED follow-up data confirm Exact Sciences' approach to detecting multiple cancers at earlier stages of disease, and show that early detection enables successful treatment and long-term freedom from cancer in patients," said Tom Beer, MD, Chief Medical Officer, Multi-Cancer Early Detection, Exact Sciences.
  • In addition, Exact Sciences will present a new, long-term Surveillance, Epidemiology, and End Results (SEER) analysis showing that the Oncotype DX Breast Recurrence Score® test is prognostic for breast cancer-specific mortality (BCSM) in patients with invasive ductal carcinoma (IDC) and invasive lobular breast cancer (ILC).
  • The Oncotype DX Breast Recurrence Score test is a prognostic genomic test designed to predict the likelihood of disease recurrence and chemotherapy benefit for patients with early-stage breast cancer, which Exact Sciences clinically validated in the TAILORx and RxPONDER trials.
  • Abstract #e22508 (E-pub): A flexible quantitative framework to assess the potential contribution of early cancer detection to improved cancer survival.

Global Personalized Medicine Biomarkers Market to 2033: Rising Usage of Diagnostics to Determine the Effect of Biomarkers Fuels the Sector - ResearchAndMarkets.com

Retrieved on: 
Monday, April 3, 2023
Biotechnology, Pharmaceutical, Health, Probability, CDRH, Prevalence, Diabetes, Therapy, Microsatellite instability, Survival, FDA Center for Devices and Radiological Health, Medicine, Biomarker, Projection, HER2, Patient, Physician, Agilent Technologies, Conditional sentence, Diagnosis, Growth, Neoplasm, Cardiology, Device, FDA, Breast cancer, Neurology, Gene, Safety, Oncotype (Denmark), Medical imaging, Pharmaceutical industry, Pembrolizumab

However, high price of personalized medicine and lack of awareness are predicted to limit market growth are expected to restrain the market growth.

Key Points: 
  • However, high price of personalized medicine and lack of awareness are predicted to limit market growth are expected to restrain the market growth.
  • Technological advances in the development of biomarkers is expected to propel the market growth during the forecast period.
  • As the need for individualised therapy increases significantly, technological advances in the discovery of biomarkers are increasing quickly.
  • Rise in usage of diagnostics to determine the effect of a biomarker is predicted to fuel the market growth during the projected period.

VieCure and Exact Sciences Enter Strategic Collaboration Aimed at Improving Patient Access to Genomic Testing

Retrieved on: 
Monday, March 6, 2023
Research, Technology, Health Technology, Software, General Health, Health, Science, Oncology, Artificial Intelligence, Other Science, Workflow, Partnership, Patient, Cancer, Informatics, Exact sciences, Oncotype (Denmark), Multimedia, A.I, Medical imaging, Nursing

“VieCure and Exact Sciences, together, are accelerating the adoption of precision oncology in the community cancer care setting,” said Dr. Fred Ashbury, Chief Scientific Officer at VieCure.

Key Points: 
  • “VieCure and Exact Sciences, together, are accelerating the adoption of precision oncology in the community cancer care setting,” said Dr. Fred Ashbury, Chief Scientific Officer at VieCure.
  • Exact Sciences’ tests provide critical diagnostic, prognostic, and therapeutic insights to inform patient-specific treatment plans.
  • These data are complex, considerable, and can be difficult to access and interpret in the community oncology setting.
  • “By streamlining the workflow, our VieCure partnership will help accelerate access to our test portfolio for community oncologists and their patients.”

MDxHealth Provides Updated and Supplemental Financial Information Related to Acquisition of GPS Test

Retrieved on: 
Friday, January 20, 2023
Financial statement, Exact sciences, Security (finance), Genomic Health, Urology, Form 6-K, Oncotype (Denmark), Exhibit, Acquisition, Genomics, GPS, Bank, Leymus innovatus

IRVINE, CA, and HERSTAL, BELGIUM – January 20, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today provided supplemental information related to its acquisition of the Oncotype DX® GPS (Genomic Prostate Score®) test on August 2, 2022 (the “GPS Test Acquisition”), from Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (“Exact Sciences”).

Key Points: 
  • IRVINE, CA, and HERSTAL, BELGIUM – January 20, 2023 – MDxHealth SA (NASDAQ/Euronext: MDXH), a commercial-stage precision diagnostics company, today provided supplemental information related to its acquisition of the Oncotype DX® GPS (Genomic Prostate Score®) test on August 2, 2022 (the “GPS Test Acquisition”), from Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (“Exact Sciences”).
  • In addition, mdxhealth completed its integration and restructuring of the urology focused sales and customer success teams.
  • In addition, one-time additional financial expense of approximately $1.2 million related to replacing the Company’s debt facility was recorded.
  • These financial statements provide detailed disclosures, among other things, on the GPS Test Acquisition as well as the new debt facility with Innovatus which replaced the Kreos debt facility.

Exact Sciences Announces Preliminary Fourth Quarter 2022 Results

Retrieved on: 
Sunday, January 8, 2023
Cancer, COVID-19 testing, Oncotype (Denmark), COVID-19, Exact sciences, News, Acquisition, Patient, Precision, Video game, Pharmaceutical industry, Potash, Chemical, Exact Sciences (company), Biomatrica

MADISON, Wis., Jan. 8, 2023 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the company expects to report revenue between $550.7 million and $552.7 million for the fourth quarter ended Dec. 31, 2022.

Key Points: 
  • "Exact Sciences' fourth quarter results show the strength of our business and the momentum building behind the best brands in cancer diagnostics, Cologuard® and Oncotype DX®," said Kevin Conroy, chairman and CEO.
  • Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2022.
  • The revenue ranges presented in this news release for the fourth quarter of 2022 and for the year ended Dec. 31, 2022 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2022.
  • Exact Sciences plans to report 2022 financial results during its February 2023 earnings call.