Category Archives: Genetic Medicine

September 2, 2020 An international, first-of-its-kind cardiology trial used personalized genetic testing to reduce by 34 per cent the number of serious adverse events following balloon angioplasty, a treatment for the most common form of heart disease.

For patients undergoing percutaneous coronary intervention (PCI), the choice of antiplatelet therapy can be critical to post treatment success, and to minimize the chance of heart attack or stroke.

The TAILOR-PCI trial, co-led by principal investigators Michael Farkouh, M.D., cardiologist and Multinational Clinical Trials Chair at the Peter Munk Cardiac Centre and director of the Heart and Stroke/Richard Lewar Centre of Excellence in Cardiovascular Research, University of Toronto, and Naveen Pereira, M.D., professor of medicine and cardiologist at Mayo Clinic, studied the effectiveness of genetic-guided therapy in patients that have had PCIs when compared to conventional therapy.

The trial introduces the concept and validates the approach to personalized medicine when it comes to antiplatelet therapy, and therefore allows our physicians to potentially change their practice based on the needs of patients undergoing PCI, Farkouh said. This will potentially inform the kinds of therapies patients with heart disease are prescribed after PCI world-wide.

Placement of a balloon and metal stent inside a heart artery can irritate the blood vessel and cause it to clot, which can block the artery from being treated. PCI patients are prescribed medications to prevent their blood from clotting the most common medication used is clopidogrel, which stops blood platelets from sticking together and prevents clots from forming. However, in almost a third of all patients, the gene (CYP2C19) required to activate clopidogrel does not work.

As a result, patients with this genetic variant may be at a higher risk of experiencing adverse cardiovascular events, such as heart attack or stroke in the year following their procedure.

Current guidelines do not recommend genetic testing when prescribing clopidogrel, and the trial was designed to determine if genetic testing would decrease cardiovascular complications after PCI.

The Journal of the American Medical Association (JAMA) published the results of the TAILOR-PCI trial on Aug. 25, 2020.[1] The trial enrolled 5,302 patients treated for heart artery blockage with one or more stents, and followed them for one year.

Half the group was tested for the CYP2C19 gene variation, and carriers (35%) were treated with the alternative anti-platelet medication, Ticagrelor. The remainder of the group was given Clopidogrel, as was the entire control group of patients who did not receive genetic testing before PCI.

Although the TAILOR-PCI trial did not meet its primary endpoint of demonstrating a 50 per cent reduction at one-year post-procedure, trends did show a benefit towards genetic testing with a 34 per cent reduction in serious adverse cardiovascular events.

Although these results fell short of the effect size that we predicted, they nevertheless provide a signal that offers support for the benefit of genetically guided therapy, with approximately one third fewer adverse events in the patients who received genetically guided treatment compared with those who did not, Pereira said.

A post-hoc analysis of the trial also showed a nearly 80% reduction in the rate of adverse events in the first three months of treatment among patients who received genetically guided therapy compared with those who did not.

Since the studys design in 2012, the standard of care following PCIs has greatly improved. Drug-coated stents and other treatments have reduced the rate of adverse events for patients in a year, but at the same time made it more difficult for the trial to reach its goal.

The trial is currently undergoing an extended follow-up beyond the original 12-month period.

The study was funded by Mayo Clinic, Mayo Clinic Center for Individualized Medicine and the National Heart, Lung and Blood Institute. Spartan Bioscience Inc. supplied the point-of-care genetic tests used.

Find more news on antiplatelet therapies

Reference:

1. Naveen L. Pereira, Michael E. Farkouh, Derek So, et al. Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary InterventionThe TAILOR-PCI Randomized Clinical Trial. JAMA. 2020;324(8):761-771. doi:10.1001/jama.2020.12443.

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Trial Shows Benefit of Using Genetic Testing to Tailor Antiplatelet Therapy - Diagnostic and Interventional Cardiology

CAMBRIDGE, England--(BUSINESS WIRE)--Illumina, Inc. (NASDAQ: ILMN) today announced a collaboration with 54gene, a health technology company whose mission is to advance precision medicine capabilities in Africa through research, advanced molecular diagnostics and clinical programs. The partnership will support the establishment of a new genetics facility in Lagos, Nigeria, equipped with a suite of Illumina's cutting-edge sequencing and high-density microarray technology platforms, which will generate genetic information for health research and drug development.

Africa contains more genetic diversity than any other continent because the African genome is the oldest human genome. Yet it is estimated that fewer than 3% of the genomes analyzed come from Africans, making it a potentially rich source of new genetic information for health and drug discovery research, which 54gene intends to leverage as a global research resource while ensuring Africans benefit from cutting-edge medical innovations.

Paula Dowdy, SVP, General Manager EMEA, Illumina, said, Its incredibly important to ensure equitable access to genomic sequencing technology across the world so that genomes can be interpreted in the context of global diversity. Through partnerships such as this with 54gene, we aim to remove barriers of access to sequencing and expand the benefits of genomics to as many people as possible.

54gene Founder and CEO Dr. Abasi Ene-Obong said, The addition of Illuminas cutting-edge technology to our research and diagnostic capabilities is a critical step for 54gene in fulfilling our mission of equalizing access to precision medicine. This is part of our wider commitment to build capacity and infrastructure in Africa, which will allow us to significantly expand genomics research, while also improving health outcomes on the continent. Alongside our many partners in the African medical and scientific community, we want to make advanced molecular diagnostics more accessible to the region, while creating hundreds of skilled jobs in molecular biology and bioinformatics.

Through the partnership, African samples stored in 54genes de-identified biobank, will be genotyped, sequenced and analyzed without the need to send samples overseas, reflecting Illuminas commitment to enabling Africa to expand its genomic capabilities. Having local infrastructure will reduce costs and turnaround time for test results. Illumina will also deliver its renowned training to support the use of its sequencing and microarray equipment and ensure ongoing support for 54genes growing team of molecular scientists.

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To learn more, visit the Illumina News Center.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit http://www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

About 54gene

54gene is a health technology company advancing the state of healthcare through large-scale discovery and translational research, advanced molecular diagnostics, and inclusive clinical programs for the benefit of Africans and the global population. Founded in 2019, 54gene utilizes human genetic data derived from diverse African populations, to improve the development, availability, and efficacy of medical products and diagnostics that will prove beneficial to Africans and the wider global population.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements are based on our expectations as of the date of this release and may differ materially from actual future events or results. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are our ability to expand the adoption and use of genomics, especially in clinical settings, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts expectations, or to provide interim reports or updates on the progress of the current quarter.

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Illumina Collaborates With 54gene in the Creation of a World-Class Genomics Facility in Nigeria - Business Wire

DUBLIN, Sept. 2, 2020 /PRNewswire/ -- The "RNA-interference (RNAi) Market - Growth, Trends, and Forecast (2020 - 2025)" report has been added to ResearchAndMarkets.com's offering.

The RNA-interference (RNAi) market is expected to witness a CAGR of 10.12% during the forecast period. Certain factors that are driving the market growth include the increasing number of applications in molecular diagnostics, particularly in cancer and improving synthetic delivery carriers and chemical modifications to RNA.

Cancer diagnosis and treatment is currently undergoing a shift with the incorporation of RNAi techniques in personalized medicine and molecular diagnostics. The availability of high throughput techniques for the identification of altered cellular molecules and metabolites allows the use of RNAi techniques in various cancer diagnosis and targeting approaches. For diagnostic purposes, small interfering RNAs (siRNA) or microRNAs (miRNA) can be utilized. The commercial availability of siRNAs to silence virtually any gene in the human genome is dramatically accelerating the pace of molecular diagnosis and biomedical research. Thus, increasing the application of RNAi in molecular diagnosis and its viability as a therapeutic technique is expected to drive the growth of the RNAi market during the forecast period.

However, in recent years, there has been a decline in FDA drug approval rates. Getting FDA approval for a new drug has become extremely challenging. It approved less than half the number of new drugs in 2016 (19 so far) when compared to 2015 (45 total) and 2014 (41 total). Hence, despite the large investments, there has been a decline in the number of innovative drugs manufactured. FDA explains manufacturing standards and other complying issues as the major reasons for this declining trend. This can impede the growth of the RNAi therapeutics, especially since the miRNAs and siRNAs fall into the relatively new field of genetic medicine, wherein they may require more intensified clinical trials. The highly extensive clinical trials effectively result in low approval rates of drugs. This would mean that the stringent guidelines will be a major restraint for the growth of the market.

Key Market Trends

Oncology is Expected to Hold Significant Market Share in the Therapeutics Type

According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer. The number of new cases is expected to rise by about 70% over the next two decades.

Recent advancements, such as the development of small interfering RNA (siRNA) tolerant to nucleases and the development of non-viral vectors, such as cationic liposomes and nanoparticles, can overcome this obstacle and facilitate the clinical use of RNAi-based therapeutics in the treatment of cancer.

Substantial pipeline for cancer therapies by companies and institutes such as Enzon Pharmaceuticals (Santaris Pharma), University of Texas, OncoGenex, Isarna Therapeutics, Astrazeneca (Ionis Pharmaceuticals), and INSYS Therapeutics, Inc. are expected to drive the market. In addition, many companies have invested in R&D for nanocarriers to deliver oligonucleotides for cancer treatment, which is expected to contribute to the oncology verticle.

North America Dominates the Market and Expected to do the Same in the Forecast Period

The U.S. has a number of RNAi therapeutics that are in developmental pipelines. A number of biotechnology companies have made considerably high investments for RNAi therapeutic development. Big pharmaceutical developers have entered into collaboration agreements or licensing deals with a number of smaller firms in an attempt to capitalize on the expected growth in revenue that this market can have over the forecast period. For instance, AstraZeneca's agreement with Ionis pharmaceuticals is one of the big deals that are investing heavily into RNA-interference technology

Key Topics Covered:

1 INTRODUCTION

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Number of Applications in Molecular Diagnostics, Particularly in Cancer4.2.2 Improving Synthetic Delivery Carriers and Chemical Modifications to RNA4.3 Market Restraints4.3.1 Stringent FDA Regulations and Changing Reimbursement Environment4.3.2 Unstable Potentially Immunogenic Nature of RNA4.4 Porter's Five Forces Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION5.1 Application5.2 Geography

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Alnylam Pharmaceuticals6.1.2 Arcturus Therapeutics6.1.3 Arrowhead6.1.4 Dicerna Pharmaceuticals6.1.5 Quark Pharmaceuticals Inc.6.1.6 Ionis Pharmaceuticals Inc.6.1.7 Merck & Co. Inc. (Sigma Aldrich)6.1.8 Silence Therapeutics PLC6.1.9 Qiagen NV6.1.10 Phio Pharmaceuticals Corp.6.1.11 Thermo Fisher Scientific Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Global RNA-interference (RNAi) Market Growth, Trends and Forecasts to 2025: Focus on Key Players Alnylam Pharmaceuticals, Arrowhead, Quark...

Researchers at Weill Cornell Medicine-Qatar (WCM-Q) have unveiled the key role played by a specific protein in the growth of the most aggressive, treatment-resistant forms of breast cancer.

A multi-institutional international study led by WCM-Qs Dr. Lotfi Chouchane, Professor of Genetic Medicine, Microbiology and Immunology, found that the effects of a protein named STXBP6 are profoundly suppressed in triple-negative breast cancers (TNBCs), which are known to relapse early and tend to spread to other organs despite intensive treatments with surgery, chemotherapy and radiotherapy.

TNBCs account for around 15-20 percent of all breast cancers and are associated with the poorest patient outcomes. While many other forms of breast cancer can now be treated relatively successfully, there is currently no effective therapy that specifically targets TNBCs.

The study showed that the STXBP6 protein helps regulate and promote a natural cellular process called autophagy in which old and damaged cells are metabolized or killed off in order to allow newer, healthier ones to grow. In cancer cells, autophagy suppresses tumor growth by inhibiting cancer cell survival and inducing cell death. When autophagy is suppressed in certain circumstances, cancer cells are more able to grow and proliferate.

Dr. Chouchane said: There is a real need to develop new therapies that specifically target triple-negative breast cancers because they do not respond well to existing treatments. In this study, we were able to significantly enhance our understanding of the mechanisms that make TNBCs so aggressive and treatment-resistant, which we hope will provide targets for the development of effective new therapies for TNBCs to significantly improve patient outcomes.

Triple-negative breast cancers are so called because the cancer cells do not have estrogen or progesterone receptors (which are targets for hormone-based therapies) and because they do not make a protein called HER2 (which is a target for antibody-based therapies) like some other forms of breast cancer.

The study, titled STXBP6, reciprocally regulated with autophagy, reduces triple negative breast cancer aggressiveness, also involved researchers at Weill Cornell Medicine in New York, Sidra Medicine and Hamad Medical Corporation in Doha, and the University of Groningen in the Netherlands. The research has been published inClinical and Translational Medicine, a prestigious medical journal.

Dr. Chouchane explained that laboratory analysis showed the STXBP6 protein interacting with another protein, named SNX27, which is known to play a key role in autophagy. Furthermore, the researchers found that increased function of the STXBP6 protein significantly reduced TNBC cells migratory ability in cell-based in vitro experiments and also reduced tumor metastasis in mouse model-based in vivo testing. However, while autophagy appears to be heavily involved in maintaining cellular health and preventing tumor initiation, the process has a paradoxical dual role and in other circumstances can actually facilitate tumor survival, depending on a variety of factors such as cancer type and stage.

Dr. Chouchane added: This multi-institutional study represents a new paradigm in our understanding of the role of autophagy in breast cancers, but it is an extremely complex and multifaceted process. We believe much more research is needed to understand in detail the role of autophagy throughout the many different development stages of cancer in order to create a new class of therapeutic strategies that are truly effective and safe.

The study was supported by funding from the Biomedical Research Program of WCM-Q and by a grant from the Qatar National Research Fund (NPRP9-459-3-090).

Dr. Khaled Machaca, WCM-Q Professor of Physiology and Biophysics/Senior Associate Dean for Research, Innovations, and Commercialization, said: This cutting-edge research paves the way for further investigations into the cellular processes that allow triple-negative breast cancers to resist current therapeutic strategies. Furthermore, the study provides extremely useful targets to aid the design of new, more effective cancer drugs in the future. These are very positive developments toward applying our research findings to improve healthcare delivery in Qatar in the long term.

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WCM-Q Research Reveals Underlying Mechanisms of Aggressive Breast Cancers - Al-Bawaba

The most common genetic cause of alterations in pediatric patients with papillary thyroid cancer (PTC) were fusion genes, which were associated with more aggressive disease, according to a study published in Thyroid.

In this study, several novel rearrangements were identified, and the fusion genes seemed to be a molecular marker number one in this patient population.

Overall, the study included 93 pediatric patients who had undergone thyroid surgery between 2003 and 2019 at the Department of Ear, Nose, and Throat, Second Faculty Medicine, Charles University, and Motol University Hospital in Prague. The mean age of patients at diagnosis was 14.5 3.4 years, and the female to male ratio was 2.6 to 1. Eighty-two patients had a total thyroidectomy and 11 had a subtotal thyroidectomy, where 10 were completed to total thyroidectomy.

The mean tumor size was 22.1 13.7 mm, and the investigators noted that 17 patients had microcarcinoma. Twenty-six patients (29.9%) had PTC of classical variant, 20 (23.0%) had classical and follicular variant, 29 (33.3%) had follicular variant, 3 (3.4%) had solid variant, 3 (3.4%) had a mixture of classical/follicular/solid variant, 2 (2.3%) had diffuse sclerosing variant, 2 (2.3%) had columnar variant, 1 (1.1%) had tall cell variant, and 1 (1.1%) had case clear cell variant.

After a median follow-up was 72 months (range, 2-198), 11 (19.3%) patients had persistent or recurrent disease at least 1 year after surgery or patients who were in remission and later had a malignant object thyroid tissue formed. Sixteen (19.3%) patients only had biochemical evidence of persistent disease, while 56 (67.5%) remained in remission with no evidence of disease. One patient died due to advanced disease. Additionally, 10 patients were not classified because of short-term follow-up, 84 received radioactive iodine (RAI) treatment, and 8 did not receive RAI because of low-risk disease.

More than half (55.9%) of the patients had fusion genes, which included RET, NTRK1, NTRK3, ALK, BRAF, and MET. Additionally, 10 different types of RET fusions were observed in 26 patients, 4 types of NTRK3fusions in 14 patients, 1 ALK fusion in 6 patients, 2 types of NTRK1 fusions in 3 patients, 2 types of BRAFfusions in 2 patients, and 1 type of MET fusions in 1 patient. Overall, 20 types of fusion genes were identified in the study, 11 of which were interchromosomal and 9 were intrachromosomal rearrangements.

Investigators detected 2 co-existing RET fusions in 1 PTC nodule, which included ACBD5/RET fusion with juxtaposition of exon 11 of the ACBD5 gene and exon 12 of RET gene in the first and BBIP1/RET fusion with a juxtaposition of exon 1 of the BBIP1 gene and exon 8 of the RET gene. CCDC6/RET rearrangement was the most common fusion gene, which was observed in 13 patients (14%), while 1 of these patients had a novel isoform including a part of exon 9 of RET gene. Other rearrangements that were observed more commonly included ETV6/NTRK3 in 10 patients (10.8%), NCOA4/RET, and STRN/ALK both in 6 patients (6.5%) and RBPMS/NTRK3 found in 2 patients (2.2%). The remaining fusions were not recurrent.

BRAF fusions with partner genes, CUL1, and OPTN were reciprocal, and the IRF2BP2/NTRK1 fusion gene has 2 isoforms, 1 being a fusion of exon 1 and the second of exon 2 of the IRF2BP2 gene with exon 10 of the NTRK1 gene. Every isoform was found in a different patient, and no patients with fusion genes had a prior history of radiation exposure before their PTC diagnosis.

The investigators also compared the samples positive for the fusion gene to those that did not harbor this mutation. Positive samples were associated significantly with the mixture of classical and follicular types of PTC (P =.025), and the fusion-positive samples were also significantly associated with extrathyroidal extension (P <.001), higher T classification (P =.009), lymph node metastases (P <.001), distant metastases (P =.021), chronic lymphocytic thyroiditis (P =.001), and frequent occurrence of psammoma bodies (P =.004). Patients who were positive for the fusion gene has also received more frequent multiple doses of RAI therapy (P=.008). Borderline statistically significant associations were observed for features such as tumor size larger in fusion gene-positive tumors (P =.057), number of microcarcinomas higher in fusion gene-negative tumors (P=.052), and a higher number of patients who were not given RAI treatment (P =.058).

Samples that were positive for the fusion genes were different from each other as well, according to the fused oncogene involved. A statistical analysis was only able to be performed between RET and NTRK3 fusion gene-positive samples because of the low number of samples in the other fusion groups. RET fusions were significantly associated with lower mean age of patients at diagnosis (P =.035), lymph node metastases (P =.033), distant metastases (P =.020), and frequent occurrence of psammoma bodies (P =.006). The NTRK3fusions were significantly associated with follicular variant PTC (P =.013).

In RET fusion gene-positive group, 11 patients (42.3%) were of prepubertal age (up to age 12) compared with only 1 patient (7.1%) in the NTRK3 fusion-positive group (P =.021).

All patients with distant metastases (n = 10) had the genetic cause of PTC detected, which was HRAS Q61R point mutation in 1 patient, NCOA4/RET in 4, CCDC6/RET in 2, RASAL2/RET in 1, EML4/MET in 1, and co-occurrence of ACBD5/RET with BBIP1/RET in 1.

Point mutations in BRAF, HRAS, KRAS, NRAS, and TERT genes were assessed in all patients, in which 18 (19%) had the BRAF V600E mutation, and the HRAS Q61R and NRAS Q61K was found in 1 patient each. No mutations were found in the KRAS gene or in the promoter region of TERT. Patients with HRAS-positive PTC (n = 1) underwent radiation treatment for Hodgkins lymphoma. The co-occurrence of fusion gene and somatic point alternation was not identified in the study.

These findings demonstrated a point mutation or fusion gene was observed in 72 pediatric patients (77.4%) with PTC, and the oncogenic alteration was unidentified in 21 patients (22.6%). Most tumors were follicular variants of PTC and T1/T2 classification predominated the tumor samples in this study. No patients had experienced recurrence or persistence of structural disease, but 1 patient had biochemical persistence of their disease while almost all of the other patients remained in remission.

Overall, this study demonstrated that fusion genes occurred in 56% of pediatric patients with PTC, and point mutations in the BRAF and RAS genes were observed in 77% of patients. Patients who harbored a fusion gene had more aggressive forms of the disease, which included more frequent extrathyroidal extension, lymph node metastases, distant metastases, and consequently had received more doses of RAI than those without the fusion gene mutations.

Reference

Pekova B, Sykorova V, Dvorakova S, et al.RET, NTRK, ALK, BRAF,andMETfusions in a large cohort of pediatric papillary thyroid carcinomas.Thyroid.Published Online July 1, 2020. doi: 10.1089/thy.2019.0802

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Fusion Genes Associated With More Aggressive Papillary Thyroid Cancer in Pediatric Patients - Targeted Oncology

A new platform that can help identify individuals who are at high risk of hereditary diseases has launched.

Developed by FamHis Inc, FamGenix is a free patient mobile app that is being released worldwide, following a soft launch last November for patients, and the release of the provider portal for clinicians last month. Servers have so far been launched in the US and Europe, and are planned for Canada and Australia in October.

The platform facilitates a telemedicine-based approach to gathering family health histories, aiming to save time and improving accuracy. The concept behind FamGenix is that patients are in control of their own data. They are able to communicate with family members through a feature called FamShare, allowing a secure exchange of data to provide an accurate family history.

Each family member can control their own health record and privacy settings. Important health information, like genetic test results, can be easily shared with other family members via the app, facilitating the process of family tracing for genetic conditions.

With 25 years in the industry, Ive seen firsthand the benefits of an accurate family health history and the effect it has on decision making for healthcare providers and their patients, said Michael Brammer, Founder and CEO of FamHis, Inc.

But the idea that its something to address only when patients are facing a health crisis, is short-sighted. FamGenix is much more than a simple screening tool and is the first of its kind to empower patients to own and maintain their own family health history, indefinitely. Preventative healthcare is the future of medicine and it begins with family history.

Healthcare providers can review the patient data, and the system screens patients to identify those who are high-risk - in other words, who meet criteria for further genetic counseling or testing.

Standard or custom questionnaires help to identify any condition (not just cancer) or other data needed for clinical or research purposes. There is also a white-label option for healthcare providers who want to brand the app as their own in the app stores. FamHis has signed their first white-label license with a prestigious cancer center and has pilots planned in several countries.

The app is available for download from the App Store and Google Play, while healthcare professionals can access a free trial.

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Health history platform launches to trace genetic conditions | Digital Healthcare - Healthcare Global - Healthcare News, Magazine and Website