#BRACAnalysis

[visionarycentreforwomen]

Understanding BRACAnalysis®: Hereditary Cancer Testing

BRACAnalysis® is additionally an essential clinical genetic test that determines the presence of mutations in the high-risk BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer syndrome. People with such mutations have up to 87 percent of chances of getting breast cancer and up to 44 percent for ovarian cancer before they are 70 years of age. This relatively simple test can be done by a blood sample, a saliva swab just as well. Gene knowledge can help both you and your doctor to create a healthy minimizing healthcare risks future in the future. When a mutation is identified, measures such as enhanced screening, chemoprevention, and in some cases preventive surgeries may also be useful in managing cancer risks optimally.More so, research in the field has focused on the possible use of preventive measures such as chemoprevention in the prevention of mutation related cancers.

Check out: Bracanalysis hereditary cancer testing

[tritonmarketresearchamey]

Companion Diagnostics Market: What’s New?

With rising health consciousness and expenditure, precision medicine has emerged as a major solution to treating chronic conditions. Estimates indicate that the personalized medicine segment is expected to account for around 40% by the end of 2022, with oncology being a major therapeutic area. As a result, this growth is expected to support the expansion of the companion diagnostics market as CDx tests identify the right drug for a specific patient pool.

Triton Market Research’s report infers that the global companion diagnostics market is expected to progress at a CAGR of 12.84% during the forecast period 2022-2028.

Presently, medical treatments are typically designed using uniform patterns, with patients with the same disease undergoing matching treatments. This trial-and-error style often becomes time-consuming and ineffective. Hence, the development of precision medicine with the help of CDx widens the studied market’s scope.

CDx Development: Technological Advancements Backs Regional Growth

In addition to a growing focus on precision medicine, the expansion of the companion diagnostics market is also fueled by technological advancements. Top trends that support the market’s growth globally, especially in the Asia-Pacific, include:

Predictive Biomarkers have proven vital in calculating responses to certain therapeutic interventions. For instance, the Oncotype Dx and MammaPrint tests and KRAS employ predictive biomarkers, providing the most effective treatment to breast and colorectal cancer patients. Estimates suggest that the oncology category secures the majority of shares in the market in terms of indication. As a result, biomarkers have gained significant prominence among oncologists across nations, including India. For instance, Tata Memorial Hospital, NIMHANS, and AIIMS are striving to identify new genes and biomarkers, ultimately generating opportunities for the Asia-Pacific companion diagnostics market.

Polymerase Chain Reaction (PCR) leads the mechanism segment in terms of revenue share in 2022. It is projected to evolve at a CAGR of 13.13% during the forecasted period. Factors such as cost-efficient, faster turnaround time, and ease of application have supported its dominance in neurology and oncology applications. Besides this, PCR-based CDx has witnessed substantial growth due to approvals such as BRACAnalysis CDx by Myriad Genetics. Such developments are expected to influence market players to expand their PCR capabilities, augmenting the companion diagnostics market’s development.

Next Generation Sequencing is another major technology fueling the CDx market development. Since NGS permits rapid sequencing, it has supported major advances in determining the molecular basis of various chronic conditions. NGS is expected to become the fastest-growing segment in the mechanism category. In this regard, PCR techniques are expected to support the success of NGS technology in the upcoming years. To illustrate, NGS diagnosis and PCR techniques offer high-precision care with less turnaround time. The rising competency in genome sequencing has also generated substantial opportunities for vendors like Shuwen Biotech and Simcere Diagnostics in the Chinese companion diagnostics market.

Competitive Landscape: Strategic Highlights & Latest CDx Approvals

The inclusion of analytics and big data has helped identify various biomarker-based illness indications regularly. This has triggered businesses to enter the market through innovations. Moreover, since it’s easy to shift from one product to another, the competition among existing players has elevated over the years. Such developments have thus led to the advent of new strategies to launch and gain approvals for their CDx devices.

In August 2022, Roche Diagnostics gained approval from FDA for VENTANA MMR RxDx Panel, the first immunohistochemistry CDx test. Based on cancer biomarkers, it helps detect solid tumor patients.

Foundation Medicine’s FoundationOne CDx and Liquid CDx were authorized with various companion diagnostics claims by the FDA in June 2022.

In May 2022, BioMerieux announced approval from FDA for its BIOFIRE Joint Infection Panel. The panel tests for 31 pathogens implicated in acute joint infections and contains 8 AMR genes to optimize therapy.

Evotec SE and BioMeriux, in July 2022, declared their partnership to create the next generation of antimicrobial and actionable diagnostics to prevent antimicrobial resistance.

In July 2021, Illumina expanded its oncology partnerships with Bristol Myer Squibb, Kura Oncology, Myriad Genetics, and Merck. This joint venture aims to develop tools for precision oncology.

Growth Prospects: CDx for Targeted Cancer Medication

Earlier, the commercial success of Herceptin and Gleevec revolutionized companion diagnostics globally. However, the increased prevalence of cancer cases has led to a dramatic shift in the drug development process, from uniform to precision medicine approach, increasing the need for new CDx solutions. Hence, the demand for predictive biomarkers for targeted cancer therapeutics is expected to take center stage, thereby creating opportunities for the companion diagnostics market.

FAQ:

Q1) What is the size of the companion diagnostics market?

The companion diagnostics market obtained $5314.48 million and is expected to gain revenue worth $12740.68 million by 2028.

Q2) What are the key end-users of the companion diagnostics market?

The key end-users include pharmaceutical and biopharmaceutical companies, reference laboratories, and others.

[ptmasterguide]

Olaparib (Description-19)

In this article we will discuss Olaparib (Description-19). So, let’s get started. (Clinical Studies-3) Of the 391 patients randomized in SOLO-1, 386 were retrospectively or prospectively tested with a Myriad BRACAnalysis test and 383 patients were confirmed to have deleterious or suspected deleterious gBRCAm status; 253 were randomized to the Olaparib arm and 130 to the placebo arm. Two out of…

[tritonmarketresearch]

Companion Diagnostics Market: What’s New?

With rising health consciousness and expenditure, precision medicine has emerged as a major solution to treating chronic conditions. Estimates indicate that the personalized medicine segment is expected to account for around 40% by the end of 2022, with oncology being a major therapeutic area. As a result, this growth is expected to support the expansion of the companion diagnostics market as CDx tests identify the right drug for a specific patient pool.

Triton Market Research’s report infers that the global companion diagnostics market is expected to progress at a CAGR of 12.84% during the forecast period 2022-2028.

Presently, medical treatments are typically designed using uniform patterns, with patients with the same disease undergoing matching treatments. This trial-and-error style often becomes time-consuming and ineffective. Hence, the development of precision medicine with the help of CDx widens the studied market’s scope.

CDx Development: Technological Advancements Backs Regional Growth

In addition to a growing focus on precision medicine, the expansion of the companion diagnostics market is also fueled by technological advancements. Top trends that support the market’s growth globally, especially in the Asia-Pacific, include:

Predictive Biomarkers have proven vital in calculating responses to certain therapeutic interventions. For instance, the Oncotype Dx and MammaPrint tests and KRAS employ predictive biomarkers, providing the most effective treatment to breast and colorectal cancer patients. Estimates suggest that the oncology category secures the majority of shares in the market in terms of indication. As a result, biomarkers have gained significant prominence among oncologists across nations, including India. For instance, Tata Memorial Hospital, NIMHANS, and AIIMS are striving to identify new genes and biomarkers, ultimately generating opportunities for the Asia-Pacific companion diagnostics market.

Polymerase Chain Reaction (PCR) leads the mechanism segment in terms of revenue share in 2022. It is projected to evolve at a CAGR of 13.13% during the forecasted period. Factors such as cost-efficient, faster turnaround time, and ease of application have supported its dominance in neurology and oncology applications. Besides this, PCR-based CDx has witnessed substantial growth due to approvals such as BRACAnalysis CDx by Myriad Genetics. Such developments are expected to influence market players to expand their PCR capabilities, augmenting the companion diagnostics market’s development.

Next Generation Sequencing is another major technology fueling the CDx market development. Since NGS permits rapid sequencing, it has supported major advances in determining the molecular basis of various chronic conditions. NGS is expected to become the fastest-growing segment in the mechanism category. In this regard, PCR techniques are expected to support the success of NGS technology in the upcoming years. To illustrate, NGS diagnosis and PCR techniques offer high-precision care with less turnaround time. The rising competency in genome sequencing has also generated substantial opportunities for vendors like Shuwen Biotech and Simcere Diagnostics in the Chinese companion diagnostics market.

Competitive Landscape: Strategic Highlights & Latest CDx Approvals

The inclusion of analytics and big data has helped identify various biomarker-based illness indications regularly. This has triggered businesses to enter the market through innovations. Moreover, since it’s easy to shift from one product to another, the competition among existing players has elevated over the years. Such developments have thus led to the advent of new strategies to launch and gain approvals for their CDx devices.

In August 2022, Roche Diagnostics gained approval from FDA for VENTANA MMR RxDx Panel, the first immunohistochemistry CDx test. Based on cancer biomarkers, it helps detect solid tumor patients.

Foundation Medicine’s FoundationOne CDx and Liquid CDx were authorized with various companion diagnostics claims by the FDA in June 2022.

In May 2022, BioMerieux announced approval from FDA for its BIOFIRE Joint Infection Panel. The panel tests for 31 pathogens implicated in acute joint infections and contains 8 AMR genes to optimize therapy.

Evotec SE and BioMeriux, in July 2022, declared their partnership to create the next generation of antimicrobial and actionable diagnostics to prevent antimicrobial resistance.

In July 2021, Illumina expanded its oncology partnerships with Bristol Myer Squibb, Kura Oncology, Myriad Genetics, and Merck. This joint venture aims to develop tools for precision oncology.

Growth Prospects: CDx for Targeted Cancer Medication

Earlier, the commercial success of Herceptin and Gleevec revolutionized companion diagnostics globally. However, the increased prevalence of cancer cases has led to a dramatic shift in the drug development process, from uniform to precision medicine approach, increasing the need for new CDx solutions. Hence, the demand for predictive biomarkers for targeted cancer therapeutics is expected to take center stage, thereby creating opportunities for the companion diagnostics market.

[fdapremarketapp]

Bracanalysis Cdx

The Food and Drug Administration [FDA] has made public the pre-market approval [PMA] for Bracanalysis Cdx manufactured by MYRIAD GENETIC LABORATORIES from https://fda.report/PMA/P140020S022

[athiranair23]

PARP Inhibitor Biomarkers Market Analysis  (2020-2027)

#polyadenosinediphosphateribosepolymerase PARP are poly(adenosine diphosphate [ADP] -ribose) polymerase. It is a group of 17 enzymes that combine several (poly) units of ADP-ribose in a chain and transfer them to the target proteins. Poly(ADP-ribose) polymerase (PARP) inhibitor plays a vital role in the repair of single-strand DNA. PARP inhibitors are thought to become trapped at the sites of single-strand DNA breaks leading to double-strand DNA breaks when DNA replication is attempted. The double-strand DNA breaks would normally be repaired by the process of homologous recombination repair (HRR), which is a complex process including many proteins, notably BRCA1 and BRCA2 which are also known as biomarkers of PARP inhibitors.

The global PARP inhibitor biomarkers market was valued at US$ 374.9 Mn in 2019, and is expected to exhibit a CAGR of 24.5% during the forecast period (2019–2027).

Figure 1. Global PARP Inhibitor Biomarkers Market Value (US$ Mn), by Region, 2019

Source: Coherent Market Insights Analysis (2020)

The increasing prevalence of cancer globally is expected to drive growth of the global PARP inhibitor biomarkers market during the forecast period

Cancer is a class of chronic diseases characterized by out-of-control growth of cells. According to the National Cancer Institute report published in 2013 stated that there are over 100 different types of cancers that can be described from the type of cells they are formed from.

According to the World Health Organization’s 2018 report, cancer is the second leading cause of morbidity and mortality worldwide and was responsible for an estimated 9.6 million deaths in 2018. According to the same source, globally, around 1 in 6 deaths occur due to cancer.

 According to the American Cancer Society, in 2017, cancer was the second most common cause of death in the U.S., which accounted for around 1 out of every 4 deaths in the U.S.

Moreover, increasing incidence of breast and ovarian cancer is expected to drive the market growth during the forecast period. For instance, according to the World Cancer Research Fund International’s report of 2018, breast cancer was at the second position among the total number of cancer cases worldwide, accounting for 2,088,849 new cases in 2018.

According to American Cancer Society, in 2018, an estimated 266,120 new cases of invasive breast cancer were diagnosed among women in the U.S.

However, high cost of PARP inhibitor biomarker test kits and assays is expected to hamper the growth of the global PARP inhibitor biomarkers market. For instance, in October 2019, Myriad Genetics, Inc.’s myChoice CDx became commercially available with a list price of US$ 4,040. myChoice CDx is the first and only FDA-approved tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2.

Figure 2. Global PARP Inhibitor Biomarkers Market Share (%), by Application

Source: Coherent Market Insights Analysis (2020)

An increasing number of product approvals is expected to drive the market growth during the forecast period

Untapped markets in emerging economies can be capitalized through favorable product pricing and new product approvals, which can further facilitate use of PARP inhibitors biomarkers.

For instance, in May 2019, AstraZaneca and Merck received the Health Canada approval for Lynparza as a monotherapy maintenance treatment for adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer

Similarly, in April 2018, Myriad Genetic Laboratories, Inc., a subsidiary of Myriad Genetics, Inc., received manufacturing and marketing approval for Myriad's BRACAnalysis Diagnostic System from the Japanese Ministry of Health, Labour, and Welfare to be used as a companion diagnostic with the PARP inhibitor, Lynparza

Key Players

Major players operating in the global PARP inhibitor biomarkers market include Myriad Genetics, Inc., F. Hoffmann-La Roche AG, Invitae Corporation, NeoGenomics Laboratories, Inc., and BPS Bioscience, Inc.

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About Us:

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What we provide:

·        Customized Market Research Services

·        Industry Analysis Services

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·        Market Intelligence Services

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Phone: +1-206-701-6702

Email : sales@coherentmarketinsights.com

Reference/Source: https://www.coherentmarketinsights.com/

[kunalcmi]

CANCER DIAGNOSTICS MARKET ANALYSIS (2020-2027)

Tumor biomarkers tests use in diagnosis of cancer include, prostate specific antigen (PSA), circulating tumor cells (CTC), Alfa-fetoprotein test (AFP), CA-19 test for pancreatic cancer, HER-2 test, BRCA test, ALK test for lung cancer, carcioembryonic test (CEA), EGFR mutation test, and RAS mutation test.

The global cancer diagnostics market is estimated to account for US$ 45,106.5 Mn in terms of value and is expected to reach US$ 83,641.9 Mn by the end of 2027.

 Global Cancer Diagnostics Market: Drivers

Increasing prevalence of cancer is expected to propel growth of the global cancer diagnostics market over the forecast period. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S.

Moreover, R&D in cancer diagnostics is also expected to aid in growth of the market. For instance, in January 2020, researchers from Universidade do Porto, Portugal, reported assessment of the role of O-glycosylation using glycoengineered gastric cancer models in the detection of CD44v9 – a major protein splice variant isoforms expressed in human gastrointestinal cancer cells—by monoclonal antibodies. 

Biopsy held dominant position in the global cancer diagnostics market in 2019, accounting for 35.1% share in terms of value, followed by Imaging and Tumor Biomarkers Tests, respectively.

 Figure 1. Global Cancer Diagnostics Market Share (%), by Value, by Test Type, 2019

Global Cancer Diagnostics Market: Restraints

Inadequate reimbursement policies are expected to hinder growth of the market. There have been various advancements in radiology with regard to imaging equipment in the recent past. However, most medical insurance companies do not offer reimbursement for procedures using Computer-aided Detection (CAD). As a result, people tend to choose conventional methods for diagnosis such as biopsy, pathological test or conventional imaging methods such as mammography, and MRI procedures.

Moreover, high price of cancer detection software is also expected to hamper growth of the market. Computer-aided Detection (CAD) software is available with a one-year license and hospitals have to renew it each year. Moreover, some insurance providers are opting out of the CAD procedure reimbursement as it is deemed extravagant and not preferred by senior radiologists

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 Global Cancer Diagnostics Market: Opportunities 

Development of biopsy platforms for companion animal cancers is expected to offer lucrative growth opportunities for players in the global cancer diagnostics market. For instance, in January 2020, Zomedica Pharmaceuticals Corp., a veterinary diagnostic and pharmaceutical company, announced completing the development and manufacturing of its reference lab cancer liquid biopsy platform for canine cancers.

Moreover, use of AI in early detection of cancer is also expected to aid in growth of the market. For instance, Freenome, an AI genomics company based in the U.S., is focused on developing blood tests to detect the body’s early-warning signs of cancer, using AI. In October 2018, the company presented early data in R&D for using machine learning to detect colorectal cancer at its earliest stages.

The global cancer diagnostics market was valued at US$ 41,542.4 Mn in 2019 and is forecast to reach a value of US$ 83,641.9 Mn by 2027 at a CAGR of 9.2% between 2020 and 2027.

Figure 2. Global Cancer Diagnostics Market Value (US$ Mn), and Y-o-Y Growth (%), 2019-2027

Market Trends/Key Takeaways

Major players in the market are focused on adopting partnership strategies to enhance their market share. For instance, in February 2020, Foundation Medicine, Inc. and Chugai Pharmaceutical, Ltd. collaborated with National Cancer Center (NCC) for the use of FoundationOneLiquid, Foundation Medicine’s laboratory-developed liquid biopsy test, in the third stage of SCRUM-Japan, a cancer genomic screening consortium in Japan.

Major players in the market are also focused on adopting M&A strategies to expand their product portfolio. For instance, in January 2020, Quest Diagnostics acquired Blueprint Genetics to expand its product portfolio in genetic and rare diseases.

Global Cancer Diagnostics Market: Competitive Landscape

Major players operating in the global cancer diagnostics market include, Abbott Laboratories, F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Siemens AG, Bio Rad Laboratories Inc., GE Healthcare, Illumina, Inc., Koninklijke Philips N.V., Toshiba Medical Systems Corporation, Agilent Technologies, Inc., Aurora Imaging Technologies, Inc., Quest Diagnostics

Global Cancer Diagnostics Market: Key Developments

Major players in the market are focused on approval and launch of new products to expand their product portfolio. For instance, in May 2020, Myriad Genetics, Inc. received the U.S. Food and Drug Administration (FDA) approval for its BRACAnalysis CDx test as a CDx for Lynparza in homologous recombination repair-mutated metastatic castration-resistant prostate cancer.

Major players in the market are also focused on adopting partnership strategies to expand their product portfolio. For instance, in October 2019, Illumina, Inc. partnered with QIAGEN N.V. to broaden the availability and use of NGS-based in-vitro diagnostic kits, including companion diagnostics, for patient management.

 About Us:

Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions.

 What we provide:

Customized Market Research Services

Industry Analysis Services

Business Consulting Services

Market Intelligence Services

Long term Engagement Model

Country Specific Analysis

Contact Us:

Mr. Shah

Coherent Market Insights Pvt. Ltd.

Address: 1001 4th ave, #3200 Seattle, WA 98154, U.S.

Phone: +1-206-701-6702

Email: sales@coherentmarketinsights.com

Source: https://www.coherentmarketinsights.com/market-insight/cancer-diagnostics-market-4029

[sriramnanda-blog]

PARP INHIBITOR BIOMARKERS MARKET ANALYSIS

PARP Inhibitor Biomarkers Market – Market Insights

PARP are poly(adenosine diphosphate [ADP] -ribose) polymerase. It is a group of 17 enzymes that combine several (poly) units of ADP-ribose in a chain and transfer them to the target proteins. Poly(ADP-ribose) polymerase (PARP) inhibitor plays a vital role in the repair of single-strand DNA. PARP inhibitors are thought to become trapped at the sites of single-strand DNA breaks leading to double-strand DNA breaks when DNA replication is attempted. The double-strand DNA breaks would normally be repaired by the process of homologous recombination repair (HRR), which is a complex process including many proteins, notably BRCA1 and BRCA2 which are also known as biomarkers of PARP inhibitors.

The global PARP inhibitor biomarkers market was valued at US$ 374.9 Mn in 2019, and is expected to exhibit a CAGR of 24.5% during the forecast period (2019–2027).

Source: Coherent Market Insights Analysis (2020)

The increasing prevalence of cancer globally is expected to drive growth of the global PARP inhibitor biomarkers market during the forecast period

Cancer is a class of chronic diseases characterized by out-of-control growth of cells. According to the National Cancer Institute report published in 2013 stated that there are over 100 different types of cancers that can be described from the type of cells they are formed from.

According to the World Health Organization’s 2018 report, cancer is the second leading cause of morbidity and mortality worldwide and was responsible for an estimated 9.6 million deaths in 2018. According to the same source, globally, around 1 in 6 deaths occur due to cancer.

According to the American Cancer Society, in 2017, cancer was the second most common cause of death in the U.S., which accounted for around 1 out of every 4 deaths in the U.S.

Moreover, increasing incidence of breast and ovarian cancer is expected to drive the market growth during the forecast period. For instance, according to the World Cancer Research Fund International’s report of 2018, breast cancer was at the second position among the total number of cancer cases worldwide, accounting for 2,088,849 new cases in 2018.

According to American Cancer Society, in 2018, an estimated 266,120 new cases of invasive breast cancer were diagnosed among women in the U.S.

However, high cost of PARP inhibitor biomarker test kits and assays is expected to hamper the growth of the global PARP inhibitor biomarkers market. For instance, in October 2019, Myriad Genetics, Inc.’s myChoice CDx became commercially available with a list price of US$ 4,040. myChoice CDx is the first and only FDA-approved tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2.

Figure 1. Global PARP Inhibitor Biomarkers Market Share (%), by Application

Source: Coherent Market Insights Analysis (2020)

An increasing number of product approvals is expected to drive the market growth during the forecast period

Untapped markets in emerging economies can be capitalized through favorable product pricing and new product approvals, which can further facilitate use of PARP inhibitors biomarkers.

For instance, in May 2019, AstraZaneca and Merck received the Health Canada approval for Lynparza as a monotherapy maintenance treatment for adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer

Similarly, in April 2018, Myriad Genetic Laboratories, Inc., a subsidiary of Myriad Genetics, Inc., received manufacturing and marketing approval for Myriad's BRACAnalysis Diagnostic System from the Japanese Ministry of Health, Labour, and Welfare to be used as a companion diagnostic with the PARP inhibitor, Lynparza

Key Players

Major players operating in the global PARP inhibitor biomarkers market include Myriad Genetics, Inc., F. Hoffmann-La Roche AG, Invitae Corporation, NeoGenomics Laboratories, Inc., and BPS Bioscience, Inc.

About Us- Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. What we provide: Customized Market Research Services Industry Analysis Services Business Consulting Services Market Intelligence Services Long term Engagement Model Country Specific Analysis Mr. Shah

Coherent Market Insights Pvt.Ltd. Address: 1001 4th Ave, #3200 Seattle, WA 98154, U.S. Phone: +1–206–701–6702 Email: sales@coherentmarketinsights.com

[pharmaphorumuk]

Pfizer’s Talzenna PARP breast cancer drug approved in US

The US drug regulator has approved Pfizer’s breast cancer medicine Talzenna (talazoparib) for patients with a certain mutation.

The drug was approved by the US Food and Drug Administration (FDA) for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer.

Talzenna is a poly (ADP-ribose) polymerase (PARP) inhibitor, and is the second drug of this class approved in breast cancer, after AstraZeneca’s Lynparza (olaparib) earlier this year. It works by causing cancer cells to self-destruct by inhibiting their ability to fix damaged DNA.

The approval is based on the results of a trial, EMBRACA in which patients were either given 1mg of talazoparib or chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine).

The patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease.

The primary efficacy outcome was progression-free survival (PFS), with an estimated median of 8.6 and 5.6 months in the talazoparib and chemotherapy cohorts, respectively.

Jennifer Litton, lead investigator and associate professor in the breast medical oncology department of The University of Texas MD Anderson Cancer Center, said: “Patients with germline BRCA-positive breast cancer are typically diagnosed at a younger age than those with nonhereditary breast cancer, and there are no therapies specifically approved for them outside of current standard of care therapies.

“EMBRACA supports the potential of talazoparib to give these patients additional time without disease progression, compared to chemotherapy.”

European regulators are currently reviewing Talzenna for the same patient population, having accepted the marketing authorisation application in June.

The FDA also approved the BRACAnalysis CDx test, developed by Myriad Genetic Laboratories. This identifies patients with the criteria necessary to make them eligible for Talzenna treatment.

Patients can only be selected for treatment with Talzenna based on this diagnostic test.

BioMarin Pharmaceutical originally developed talazoparib, following which US cancer drug firm Medivation acquired all worldwide rights to the drug in August 2015 to expand its global oncology franchise. Pfizer bought Medivation in 2016 for $14 billion.

Myriad is also working with Clovis Oncology so its diagnostic tool can be used to identify best responders to its third-line advanced ovarian cancer drug Rubraca (rucaparib).

In April, the FDA approved PARP drug Rubraca as a maintenance therapy for women with recurrent ovarian cancer.

Rival PARP drugs from AstraZeneca and Tesaro – Lynparza and Zejula – are already approved in the maintenance indication for ovarian cancer, without the need for BRCA tests.

The post Pfizer’s Talzenna PARP breast cancer drug approved in US appeared first on Pharmaphorum.

from Pharmaphorum https://pharmaphorum.com/news/pfizers-talzenna-parp-breast-cancer-drug-approved-in-us/

[marketprdaily]

Myriad Genetics's stock surges after FDA approval of diagnostic test for pancreatic cancer

Myriad Genetics’s stock surges after FDA approval of diagnostic test for pancreatic cancer

Share of Myriad Genetics Inc. shot up 8.3% in premarket trading Monday, after the molecular diagnostics company said its BRACAnalysis CDx was approved by the Food and Drug Administration as a companion test to identify patients with metastatic pancreatic cancer, who are candidates for treatment with Lynparza. BRACAnalysis CDx is the only FDA-approved genetic test for this indication. Lynparza is…

[bharatiyamedia-blog]

Lynparza stalls pancreatic most cancers in sufferers with BRCA mutations: research

http://tinyurl.com/y2ntgn66 CHICAGO (Reuters) – AstraZeneca and Merck & Co’s Lynparza helped sufferers with superior pancreatic most cancers who carry BRCA gene mutations go longer with out their illness worsening than those that obtained a placebo, in keeping with knowledge from a late-stage medical trial introduced on Sunday. BRCA mutations are sometimes linked with breast and ovarian cancers, however happen in different cancers as nicely. Lynparza was examined in opposition to a placebo as a upkeep remedy in 154 sufferers with metastatic pancreatic most cancers whose tumors had not progressed after chemotherapy. Those that obtained the Merck and AstraZeneca drug on common went 7.four months earlier than their illness started to worsen, a measure generally known as progression-free survival (PFS). That in contrast with a median PFS of three.eight months for placebo, in keeping with knowledge introduced on the American School of Medical Oncology assembly in Chicago. Sufferers had been screened for BRCA1 or BRCA2 mutations utilizing Myriad Genetics’ BRACAnalysis CDx take a look at. For the 6-7% of pancreatic most cancers sufferers who carry these inherited mutations, the discovering is important. “This was clearly optimistic,” mentioned Dr. Eileen O’Reilly, a pancreatic most cancers skilled at Memorial Sloan Kettering Most cancers Middle in New York, who helped lead the research. O’Reilly mentioned the findings reinforce new pointers from the Nationwide Complete Most cancers Community recommending common BRCA testing for all sufferers with pancreatic most cancers. Mutations in BRCA genes impair the power to restore DNA injury, which might drive most cancers progress. Lynparza and different medication within the class generally known as PARP inhibitors exploit this weak point, preserving most cancers cells broken by chemotherapy from repairing themselves. Lynparza turned the primary PARP drug to succeed in the market with a U.S. approval for ovarian most cancers in late 2014. An interim evaluation, nonetheless, confirmed the drug made no important distinction in general survival. “We sometimes see about 10 to 12 months” for general survival in these sufferers, O’Reilly mentioned. Sufferers in each arms of the Lynparza research lived about 18 to 19 months. Dr. Roy Baynes, Merck’s chief medical officer, mentioned the hope is {that a} delay in most cancers development will in the end translate into longer survival. “In pancreatic most cancers, progress has been actually gradual so that is actually fairly thrilling knowledge for sufferers who’ve the BRCA mutation,” Baynes mentioned. Lynparza is a crucial progress driver for AstraZeneca, producing $647 million in gross sales final 12 months. Analysts have forecast $2.5 billion in income from the drug in 2023, in keeping with Refinitiv knowledge. [L3N20L2TP] Use in pancreatic most cancers along with breast and ovarian most cancers would increase Lynparza gross sales and cement its lead over rival PARP inhibitors Rubraca from Clovis Oncology, GSK’s Zejula and Pfizer’s talazoparib. Reporting by Julie Steenhuysen; extra reporting by Ludwig Burger in Frankfurt; enhancing by Invoice Berkrot Our Requirements:The Thomson Reuters Trust Principles. Source link

[fdapremarketapp]

Bracanalysis Cdx

The Food and Drug Administration [FDA] has made public the pre-market approval [PMA] for Bracanalysis Cdx manufactured by MYRIAD GENETIC LABORATORIES from https://fda.report/PMA/P140020S021

[megasddw-blog]

Current & Future Growth of Companion Diagnostic Market in Healthcare

The Exhaustive Study for Global Companion Diagnostic Market Research Report is added on Market Research Future. To provide detail analysis of the market structure along with forecast, about various segments and sub-segments of the Companion Diagnostic.

The Global Companion Diagnostic Market is estimated to grow with a strikingly impressive rate of 15.4% during the assessment period of 2017 to 2023. In its latest published report, Market Research Future (MRFR) minutely analyses and identifies the various factors driving the market growth. The factors identified as the contributory drivers of the market are the growing need for monitoring the safety and efficiency of drugs, increasing costs related to drug discovery and development, ameliorating demand for specific treatment methodologies of rare and chronic disorders, and advancing technologies in companion diagnostic devices. Moreover, the proliferating demand for diagnostic devices which boast the capability of detecting tumors in the initial stage of cancer is also driving the market’s growth.

On the flip side, lack of skilled professionals and technicians with such devices and lack of awareness in developing economies can pull down the growth percentage of the globular companion diagnostic market.

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Companion Diagnostic refers to as therapeutic devices that are used to diagnosis the response of treatment in the patients as well as in vitro gadgets. These devices provide essential information that is required for the effective and safe use of corresponding medicine or biological product. The outcome as in the diagnostic report helps a health care professional to determine if the benefits of a particular therapeutic product will compensate with some potentially serious side effects or risks.

Key Players:

Fervent players leading the global companion diagnostics market include Agilent Technologies (U.S.), Abbott (U.S.), ARUP Laboratories (U.S.), Myriad Genetics Inc. (U.S.), F. Hoffmann-La Roche AG. (Germany), Thermo Fisher Scientific Inc. (U.S.), and Qiagen N.V. (Germany).

Industry/Innovation/Related News:

November 27, 2018 – Invivoscribe (US), an industry pioneer in developing and manufacturing diagnostic products announced the submission of the LeukoStrat® CDx FLT3 Mutation Assay to both the US FDA and the Japan PMDA (Pharmaceuticals and Medical Devices Agency) as the companion diagnostic for quizartinib.

LeukoStrat is developed in partnership with Daiichi Sankyo as the companion diagnostic that bridges to the global phase 3 QuANTUM-R clinical trial (United States, Europe, and Asia excluding Japan).

October 09, 2018 -- Myriad Genetics, Inc. (US), a global leader in personalized medicine, announced signing of a commercialization plan with Pfizer Inc. (US), a pharmaceutical corporation that is under an existing companion diagnostic agreement, in which Myriad is pursuing U.S. Food and Drug Administration (FDA) approval for its BRACAnalysis CDx® to be used as a companion diagnostic with Pfizer’s investigational PARP (poly ADP ribose polymerase) inhibitor, talazoparib.

Segmentation:

The segmentation of the global companion diagnostic market is segmented on the basis of technology, end-user, and application.

By technology, the market comprises of In-situ hybridization, Polymerase chain reaction (PCR), and immunohistochemistry.

By end-user, the market includes clinical laboratories, pharmaceutical & biotech companies, CRO, and others.

By application, the market includes CNS diseases, cardiovascular diseases, cancer, infectious diseases, and others.

Regional Analysis

Geographical segmentation of the companion diagnostic market includes the Americas, Europe, Asia-Pacific, and the Middle East & Africa.

Americas is the market leader of companion diagnostics in the global geographical segmentation. North America stands as the superior contributor in this region over Latin America owing to a number of impactful reasons. The expensive usage of advanced diagnostic services and an imperative need to come up with a solution for cancer diagnosis and treatment is driving the market growth of companion diagnostic devices.

With the second-largest regional market after Americas, Europe contributes majorly to the global companion diagnostic market growth. Factors such as the rising demand for efficiency in the healthcare sector and a strengthening healthcare system are massively contributing to the region’s growth. Germany holds the largest market position in Europe primarily because of the residing market players in the nation.

Continuous developments and increasing healthcare expenditure in developing economies like China and India have placed the Asia-Pacific region as the market with the fastest-growing potential. Wide-spread prevalence of lifestyle-based diseases like obesity, diabetes, and cancer to drive the market growth of this region. The Middle East & Africa region is anticipated to grow in a slow and steady manner due to low healthcare expenditure and demand related to primary healthcare services.

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[strategyr-blog]

Increasing Incidence of Genetic Disorders, Advancements in Genetic Science, and Growing Awareness about Predictive Diagnostics Drive the Global Predictive Diagnostics Market

The global market for predictive diagnostics is projected to reach US$2 billion by 2024, driven by marked increase in occurrence of genetic conditions, higher level of awareness, and technological advancements in genetic science.

The global market for Predictive Diagnostics is advancing rapidly in sync with the progress attained in genetic sequencing. Predictive genetic tests determine the genetic makeup of an individual, exposing predisposition to specific diseases. Driven by a higher level of awareness and a marked increase in the occurrence of genetic conditions, technological advancements in genetic science over the last decade resulted in the development of 'targeted' therapeutics and diagnostics that deliver a more personalized healthcare approach. Thanks to progress made in proteomics and genetics, physicians are increasingly successful in identifying individuals with high susceptibility to several disorders, including CDDs (chronic degenerative diseases) before the appearance of symptoms. Likewise, screening for Breast Cancer (BRCA) gene mutations is conducted in women with close kin who have suffered from breast cancer at a young age. The market for breast cancer gene testing is on the rise, given its preventative aspect against the disease. Predictive gene tests, for instance BRACAnalysis® test from Myriad Genetics, identify women at risk. Apart from the US and Europe, densely populated developing countries, such as China, harbor the largest prospects for breast cancer gene testing market.

Oncology, a major area of interest for drug discovery companies and diagnostic tool developers, is thereby a major market for predictive diagnostic tools, with genetic testing enabling the early identification of the illness and subsequently enabling physicians to decide the most appropriate cancer treatment for specific patients. Owing to the increasing incidence of cancer cases, genetic testing, particularly for breast cancer and colorectal cancer, is expected to register the highest growth in the near future. Advancements in genetic testing space are expected to aid in tailoring personalized medicine for specific targeted markets.

As stated by the new market research report on Predictive Diagnostics, Europe represents the largest market for Predictive Diagnostics, accounting for 46.9% share in 2018. The United States represents the single largest market for predictive diagnostics, on account of various factors including the high prevalence of cancer and the need for diagnostics to detect high-risk patients; screening tests for expectant mothers to detect gene mutations that predispose to cystic fibrosis.

Asia-Pacific constitutes the fastest growing market with a CAGR of 15.7% over the analysis period. Huge population in the Asian region, led by China and India, and the ever-increasing measures towards better healthcare, make the region one of the most viable markets for predictive diagnostics.

The predictive diagnostics market is witnessing the emergence of multiple gene germline-sequencing panels.  Following the 2013 court ruling against patenting of gene, multiple gene germline-sequencing panels integrating BRCA1/2 and a few other genes, emerged in the market. These panels were offered at much less cost. Limited tests for four of the breast cancer related genes beyond the BRCA1/2 genes were adopted initially, which currently have been extended to over 100 genes with potential cancer links. This, along with technological advancements in genomics, such as Next-Generation Sequencing (NGS), is replacing conventional DNA sequencing modalities. Essentially, NGS and other high throughput methods for DNA analysis permit optimization and miniaturization of systems, and thereby enable parallel execution of several disparate sequencing reactions. The NGS method makes use of massive parallel platforms for allowing sequencing of very large DNA stretches.

Key players in the market include Abbott Molecular., Almac Group Ltd., Ambry Genetics Corp., BioGenex, Epistem Ltd., Epistem Ltd., Myriad Genetics Inc., MDxHEALTH Inc., OPKO Health, Inc., Prometheus Laboratories Inc., Proteomics International Laboratories Ltd., and QIAGEN N.V.  among others.

The research report titled “Predictive Diagnostics: Market Analysis, Trends, and Forecasts” announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, drivers, mergers, acquisitions and other strategic industry activities of major market participants. The report provides market estimates and projections for major geographic markets including the United States, Canada, Japan, Europe (France, Germany, Italy, UK, and Rest of Europe), Asia-Pacific (Excluding Japan), and Rest of World.

Global Industry Analysts, Inc. 6150 Hellyer Ave., San Jose CA 95138, USA, All Rights Reserved.

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[medipaper]

PARPi talazoparib FDA approved for deleterious gBRCAm HER2‑negative breast cancer https://medipr.org/2PGrtVY #BMN-673 #BRACAnalysis #BRCA #CDx #FDA #gBRCAm #germlineBRCA-mutated #MyriadGenetics #PARP #PARPi #Pfizer #talazoparib #Talzenna

[nonviable-hostage]

via genetics - Google News