CERTIFICATIONS, STANDARDS, REGULATIONS, AND LEGAL FRAMEWORK.
Our company, ANTIAGE GENOME INNOVATION CONSORTIUM (hereinafter “ANTIAGE GENOME OR YOU TOMORROW”), collaborates with a partner capable of processing the large volume of samples we receive and send monthly for “Genetic Polymorphism” studies. Our partners ensure that the laboratory processing the samples holds all the necessary certifications for the results to be recognized in the United States of America, as the FDA reviewed the documentation and permitted them to provide complete information related to monogenic diseases, complex diseases, distinctive traits, wellness, nutrigenetics, and ancestry. However, pharmacogenetic information cannot be delivered directly to the consumer but can be provided through medical professionals. All certifications supporting the above are filed in the quality records of “ANTIAGE GENOME.”
According to regulations, for this laboratory to operate in the U.S., a repository meeting FDA requirement, supported by compliance with ISO standards, is necessary, as well as having all required documentation for sequencing technology as mandated by the FDA. We have this in operation, as indicated in the attached information, like the case of “Illumina.” The service is provided in Europe, although the kit is marketed in the U.S. with FDA authorization.
Below we describe the essence and reasons for use of all the certifications that our partners must perform genetic polymorphism analysis according to FDA standards. ‘ANTIAGE GENOME” has all the documents (16) corresponding to the quality management certifications and good laboratory practices that correspond to the FDA requirements for operations with genetic polymorphism analysis in the USA. The list of certifications is as follows:
CERTIFICATIONS
I). ISO 17025 Certification: This certification pertains to the “Competence of testing and calibration laboratories.” It ensures that a laboratory meets international standards for conducting tests and calibrations. ISO 17025 is recognized and applied in the United States. It is used by laboratories that need to demonstrate technical competence and generate technically valid results.
II). ISO 13485 Accreditation: This certification relates to “Quality management systems for medical devices.” Specifically, ISO 13485 sets requirements for a quality management system that organizations involved in the design, production, installation, and maintenance of medical devices can use. ISO 13485 is widely recognized and used in the United States, especially by medical device manufacturers to ensure the quality and safety of medical products.
III). GLP (Good Laboratory Practice): Good Laboratory Practice (GLP) is a set of principles that ensures the quality and integrity of non-clinical laboratory studies related to product safety. GLP is crucial for non-clinical safety studies. GLP is a regulation applied in the United States, supervised by the FDA (Food and Drug Administration), to ensure that laboratory study data are accurate and reproducible.
IV). GCP (Good Clinical Practice): Good Clinical Practice (GCP) are international standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical studies involving human subjects. They ensure that clinical studies are conducted ethically, and that the data generated are credible and accurate. GCP is an essential standard in the United States, also supervised by the FDA, to ensure that clinical studies are conducted according to ethical and scientific principles.
V). GMP (Good Manufacturing Practice): Good Manufacturing Practice (GMP) are systems that ensure products are produced and controlled according to quality standards. They include the manufacturing, testing, and quality assurance of pharmaceutical and biotechnological products. GMP is mandatory in the United States and is regulated by the FDA to ensure that pharmaceutical and biotechnological products are consistently manufactured and meet appropriate quality standards
In summary, these standards and certifications to which our company adheres are crucial to guarantee the quality and safety of clinical, genomic laboratories and the manufacturing of medical and pharmaceutical products. In the United States, these certifications are widely recognized and enforced, and many of them are regulated by the FDA to ensure that products and services meet the highest standards of quality and safety.
PRIVACY
From “ANTIAGE GENOME,” we want to state that we have ensured that our partners are the most qualified to transfer knowledge about health and ancestry studies related to each person’s specific genomics, as well as their correct interpretation. Additionally, we want to assure users about the proper use of this valuable information, ensuring it is not used for purposes other than ensuring people’s health and well-being.
Therefore, we abide by the following regulations:
SECURITY
For “ANTIAGE GENOME,” privacy, confidentiality, and data security are absolute prerequisites. This is why we use the most advanced security protocols and high encryption technology, in addition to physical, technical, and administrative measures to maximize security in accordance with current legislation. All connections to and from our website are covered by SSL cryptographic protocol.
USER OBLIGATIONS
In general, the User agrees to comply with these General Conditions, as well as to follow special warnings or usage instructions contained therein or on the website, and always act in accordance with the law, good customs, and the demands of good faith, using the diligence appropriate to the nature of the service enjoyed, refraining from using the website in any way that could hinder, damage, or deteriorate its normal operation, the property or rights of ANTIAGE GENOME, its suppliers, other Users, or, in general, any third party.
Specifically, without implying any restriction on the obligation assumed by the User in general accordance with the previous paragraph, the User agrees, in the use of the website, as well as in the provision of services, to: (I) in the case of registration, the User agrees to truthfully provide the data requested and to keep it updated; (II) not to introduce, store, or disseminate through the website any information or material that is defamatory, libelous, obscene, threatening, xenophobic, incites violence, discriminates based on race, sex, ideology, religion, or any other personal or social condition or circumstance (e.g., health-related issues), or that in any way violates morality, public order, fundamental rights, public liberties, honor, privacy, or the image of third parties, and in general current regulations; (III) not to introduce, store, or disseminate through the website any computer program, data, virus, code, hardware or telecommunications equipment, or any other electronic or physical instrument or device that may cause damage to the website, to any of the services offered on the website, or to any equipment, systems, or networks of ANTIAGE GENOME and our partners, any User, suppliers of ANTIAGE GENOME and our partners, or in general any third party, or that in any other way may cause any type of alteration or prevent their normal operation; (IV) to properly safeguard the login and password provided by ANTIAGE GENOME and our partners to Users, as identifying and enabling elements for access to services offered on the website, committing not to transfer their use or allow access to them by third parties, keeping ANTIAGE GENOME harmless and assuming responsibility for damages that may arise from misuse thereof. Similarly, the User undertakes to promptly notify ANTIAGE GENOME of their loss or theft, as well as any risk of access to the login and/or password by a third party; (V) not to carry out advertising, promotional, or commercial exploitation activities through the website not expressly authorized by ANTIAGE GENOME, nor to use the contents and in particular the information obtained through the website to send advertising, send messages for direct sales purposes or for any other commercial purpose, or to collect or store personal data of third parties; (VI) not to use false identities, nor to impersonate the identity of others in the use of the website or in the use of any of the website’s services, including, where appropriate, the use of third-party passwords or access keys or in any other way; (VII) not to destroy, alter, use for their use, disable or damage the data, information, programs, or electronic documents of ANTIAGE GENOME, its suppliers, or third parties; (VIII) not to introduce, store, or disseminate through the website any content that infringes intellectual property, industrial or trade secrets of third parties, nor in general any content of which they do not have, in accordance with the law, the right to make available to third parties.
DISCLAIMER OF LIABILITY
ANTIAGE GENOME will only be liable for damages that the User may suffer because of using the website when such damage is directly attributable to ANTIAGE GENOME. Regarding the information and content included on the website or accessible through links established on it, ANTIAGE GENOME does not guarantee, in any way, either access at a specific time to such information and content, or its accuracy, timeliness, or usefulness for the User’s purposes. ANTIAGE GENOME is not responsible for any damages of any nature that may be due to the transmission, dissemination, storage, availability, reception, obtaining, or access to the contents included on the website or those accessible through links established on it.
ANTIAGE GENOME is exempt (and the User accepts) from any liability for improper or unauthorized use of the login and password and for the User’s lack of diligence in maintaining their confidentiality. Likewise, ANTIAGE GENOME is exempt (and the User accepts) from any liability for damages of any nature that may arise, by way of example and not limitation, from: (I) The presence of viruses or other harmful elements on the website or websites accessible through links established on it that may cause alterations in the computer system, electronic documents, or files of Users; (II) Interferences, omissions, interruptions, breakdowns, and/or disconnections in the operational functioning of this electronic system or in the devices and computer equipment of Users, caused by factors beyond ANTIAGE GENOME, which prevent or delay the provision of services or navigation through the system and the website; (III) Delays or blocks in the use caused by deficiencies or overloads of the Internet or other electronic systems; (IV) Actions by third parties through unlawful intrusions beyond the control of the website and not attributable to ANTIAGE GENOME; (V) Discrepancies in the information, documentation, and/or other content of the website that may exist between the electronic version and the printed version; (VI) The inability to provide the service or allow access due to causes not attributable to ANTIAGE GENOME, due to the User, third parties, or cases of force majeure.
ANTIAGE GENOME’s liability for damages of any nature that may be imputed to it will never exceed, by express agreement between the parties, the amount determined in each case in the conditions of the service acquired. In default, ANTIAGE GENOME’s total liability, except in cases of fraud or gross negligence, will be limited to the price paid by the corresponding User to ANTIAGE GENOME (excluding any taxes that may apply).
USE OF HYPERLINKS
The Internet user who wants to introduce links from their own websites to the Website must comply with the conditions detailed below, and ignorance of these will not avoid the responsibilities derived from the law. The link may only link to the home page or main page of the website but cannot reproduce it in any way (inline links, copying texts, graphics, etc.). It will be prohibited, in accordance with the applicable and current legislation at all times, to establish frames or any type of frames that wrap the website or allow the display of the contents through Internet addresses other than those of the website and, in any case, when displayed together with content unrelated to the Website in a way that: (I) Produces, or may produce, error, confusion, or deception in users about the true origin of the service or contents; (II) Constitutes an act of unfair comparison or imitation; (III) Serves to take advantage of the brand reputation and prestige of ANTIAGE GENOME; (IV) In any other way, is prohibited by current legislation.
No false, inaccurate, or incorrect statements about ANTIAGE GENOME, its address, employees, customers, or the quality of the services it provides will be made from the page introducing the link. Under no circumstances will it be stated on the page where the link is located that ANTIAGE GENOME has consented to the insertion of the link or in any way sponsors, collaborates, verifies, or supervises the services of the sender. The use of any trademark, graphic, mixed, or other distinctive sign of ANTIAGE GENOME within the sender’s page is prohibited, except in cases permitted by law or expressly authorized in writing by ANTIAGE GENOME and always allowing, in these cases, a direct link to the website in the manner established in this clause. The page establishing the link must faithfully comply with the law and, under no circumstances, link to its own or third-party content that: (I) Is illegal, harmful, or contrary to morality and good customs (pornographic, violent, racist, etc.); (II) Induces or may induce the User to the false conception that ANTIAGE GENOME subscribes, supports, adheres, or in any way supports, the ideas, statements, or expressions, lawful or unlawful, of the sender; (III) Are inappropriate or not pertinent to the activity of ANTIAGE GENOME in view of the place, contents, and theme of the sender’s website.
Likewise, the User will refrain from including any hyperlink (hereinafter, “link”) on the website directed to a website containing information or content that is illegal, contrary to generally accepted morality and good customs, and public order.
POLICY ON PERSONAL DATA PROTECTION
ANTIAGE GENOME recognizes the importance of protecting the privacy of Users of the website and has developed a Personal Data Protection Policy, which is made known to the User so that they may freely and voluntarily decide whether to provide ANTIAGE GENOME with the personal data that may be required or obtained during their use of this website and/or the request for any of the services offered therein. ANTIAGE GENOME reserves the right to unilaterally modify its Personal Data Protection Policy at any time and without prior notice to comply with the current legislation. To request information or, where applicable, proceed with the contracting or acquisition of the services offered, Users must provide certain personal data to ANTIAGE GENOME beforehand. These data will be processed to handle inquiries, if applicable, formalize distance contracts, manage, administer, provide, expand, improve, and adapt the services offered on the website, as well as carry out promotional and advertising activities through any means that may be of interest to Users.
In accordance with Organic Law 3/2018 of December 5 on Personal Data Protection and Digital Rights Guarantee, the User has the right of access, rectification, cancellation, and opposition in accordance with current regulations regarding their personal data collected as established in the preceding paragraphs. For this purpose, Users may address such requests, accompanied by a photocopy of their ID card, passport, or equivalent identification document, to the contact address provided. It is informed to interested parties that they may exercise their rights of access, rectification, and cancellation via email at [[email protected]].
The User expressly agrees to the inclusion of data collected during navigation on the website or provided by filling out any form, as well as those derived from the commercial relationship and/or delivery of acquired services, into the file. Additionally, in the event of contracting/using services offered through the Web that require the processing of especially sensitive data (related to health), the User expressly consents to the processing of such data by ANTIAGE GENOME staff, which will be carried out in accordance with the duty of secrecy and confidentiality established in Article 10 of the LOPD, implementing the security measures established in Royal Decree 1720/2007, of December 21, approving the Regulation of development of the LOPD operated under the procedural laws of our European partners.
During the data collection process, and at each location on the website where such data is requested, the User will be informed, either through a hyperlink or in the form itself, of the mandatory or optional nature of collecting such data. ANTIAGE GENOME undertakes to use the data included in the file with confidentiality, in accordance with the file’s purpose, and to fulfill its obligation to keep them and adopt all measures to prevent alteration, loss, treatment, or unauthorized access, in accordance with the LOPD Regulation and other applicable regulations always.
Finally, in the case of minors, their personal data and genetic information will also be used confidentially, always prioritizing the minor’s interest in accordance with the provisions of Organic Law 1/1996, of January 15, on Legal Protection of Minors, operated under the procedural laws of our European partners.
USE OF COOKIES
The website uses “cookies” that allow ANTIAGE GENOME to obtain a series of data from Users. What are cookies? Cookies are text and number files containing small amounts of information that can be sent to the User’s device (computer, smartphone, tablet…) when they visit our website. Although cookies are sent to a device, they cannot access personal information by themselves, nor can they transmit viruses; they simply track navigation on the website. When you revisit our website, these cookies are sent again to our website or another site that recognizes the cookie, allowing us to recognize your device.
How do we use cookies? Cookies are useful because they allow easier navigation between different pages, remember your preferences, and we use them to improve your online experience. Currently, we use session cookies of our own, as well as technical, customization, analysis, and advertising cookies. The latter allows the management of advertising spaces that appear on the website based on criteria such as the content or frequency of displaying ads. We also use Google Analytics. This cookie is used to gather information about how our website is used. We use this information to compile reports and as an aid to improving the website. We do not share this information with third parties. The cookie collects data anonymously, meaning it cannot be linked back to the user. It collects data such as the number of visitors who have used our website, where visitors come from, and which pages they have visited.
ANTIAGE GENOME is not involved, control, or information about the results; they are the responsibility of each social network. When the User registers with credentials from a social network, they authorize the respective social network to store a persistent cookie that remembers their identity and guarantees access until it expires. The User can delete this cookie and revoke access by updating their preferences on the corresponding social network. ANTIAGE GENOME recommends that Users review the terms of use and privacy and cookie policies of the social networks they use.
How can I disable cookies? You can choose to receive a notice each time a cookie is sent to your computer, or you can choose to disable all cookies. To do so, you must go to your browser’s settings menu (Internet Explorer, Firefox, Chrome…). Since each browser is different, we recommend consulting your browser’s Help menu to learn how to correctly configure your cookies. However, remember that disabling cookies may prevent you from accessing some features that make our website more efficient
The content of the website (hereinafter referred to as “the content”) which includes, by way of example but not limited to, texts, photographs, graphics, images, icons, software, links, and other audiovisual content, as well as its graphic design and source codes, is the intellectual property of ANTIAGE GENOME, or of third parties who have granted its use to ANTIAGE GENOME. This content is protected by applicable national laws and international treaties concerning intellectual property rights. Furthermore, all trademarks, trade names, or distinctive signs of any kind that appear on the website are the property of ANTIAGE GENOME or third parties who, where applicable, have authorized ANTIAGE GENOME to include and use them on the website. All industrial and intellectual property rights on this website are legally reserved, and access to or use of the same by the user should not be considered, in any way, as the granting of any license of use or right over any asset owned by ANTIAGE GENOME or third parties.
The total or partial reproduction by any means of the content, trademarks, trade names, and distinctive signs of any kind included on the website, as well as the sale, transfer, lease, distribution, public communication, transformation, or any other use without the express prior authorization of the corresponding owner, is completely prohibited and will be pursued civilly and, where appropriate, criminally, in accordance with applicable national laws and international treaties.
These general contracting conditions, together with the “Informed Consent” document and any conditions that may be established, will expressly regulate the relationships established between ANTIAGE GENOME and the users who contract the services offered through the website. We inform you that, in any case, the language in which the contract between ANTIAGE GENOME and the client will be formalized is Spanish. These General Conditions have been drafted in accordance with the provisions of the legal system of our partners under Law 34/2002 on Information Society Services and Electronic Commerce, Law 7/1998 on General Contracting Conditions, Law 7/1996 on the Regulation of Retail Trade, regulations on the protection of consumers and users, and any other applicable legal provisions.
The use and/or acquisition of any of the services offered through the website implies acceptance by the user, without reservations of any kind, of each of these General Conditions, as well as the conditions that, where applicable, regulate the acquisition. In this sense, the user acknowledges that ANTIAGE GENOME services are limited by the following issues arising from genetic research: (i) most genetic research and studies are carried out in Caucasian populations (white race) without this limiting a high percentage of coincidence for other races; therefore, the interpretations provided by ANTIAGE GENOME may not be valid on the same average if the user does not belong to the mentioned race; (ii) as a continuation of the previous point, gene-disease relationships are usually based on ethnic identity and research focuses on limited populations; therefore, such research may provide knowledge of a specific population but not an individual member, and the relationships have not been studied in many populations, so they may not be valid for other populations; and (iii) genetic research advances daily and, consequently, current knowledge about the genetics of certain individual diseases or conditions may be partial and inaccurate. Thus, as a continuation of the above, the user expressly accepts that ANTIAGE GENOME does not guarantee that its services (including the results) are error-free, 100% accurate, reliable, secure, have temporal continuity or meet certain user expectations.
ANTIAGE GENOME informs that the procedures for acquiring services are those described in these General Conditions, as well as any others specified on the screen during navigation, so the user declares to know and accept said procedures as necessary to access the services offered on the website. Any modification and/or correction of the data provided by users during navigation will be possible and must be carried out according to the instructions included on the website.
The services offered on the website, along with their characteristics and prices, will appear in the corresponding on-screen catalog. ANTIAGE GENOME reserves the right to decide at any time the services and, where appropriate, products contained and offered to users through the website. Thus, ANTIAGE GENOME may, at any time, add new services and/or products to those included on the website, it being understood, unless otherwise provided, that they will be always governed by the provisions of the General Conditions in force. Likewise, ANTIAGE GENOME reserves the right to stop providing access, at any time and without prior notice, to any of the products or services offered on the website.
USERS OF THIS WEBSITE MUST BE OVER 18 YEARS OLD and must follow the instructions included on the different screens of the website to complete the desired purchase. Additionally, the user can access the website but will not be able to complete any purchase if they reside in a country or territory where the applicable legislation prohibits them from contracting the services of ANTIAGE GENOME. In such cases, the availability of the website cannot be considered an offer by ANTIAGE GENOME of its services to individuals accessing the site from those countries or territories.
In cases where ANTIAGE GENOME’s services are to be used by minors, it will be necessary for one of their parents or, where applicable, the person holding parental authority, to contract the services. In the absence of parents, the guardian will be the only one who can contract with ANTIAGE GENOME. For ANTIAGE GENOME’s services to be provided to minors, those holding parental authority must prove this by sending a scanned copy of their ID and the minor’s ID (if they already have one), and the Family Book to ANTIAGE GENOME electronically. In the absence of an ID, a scanned copy of the passport or equivalent identity document (both parent/person with parental authority and the minor, if they already have a passport or equivalent identity document) must be provided. In case the person requesting ANTIAGE GENOME’s services for a minor is their guardian, they must prove this condition by sending a scanned copy of the court ruling or judicial resolution containing their appointment, along with their ID and the minor’s ID, if they already have one. In the absence of an ID, a scanned copy of the passport or equivalent identity document (both guardian and the minor, if they already have a passport or equivalent identity document) must be provided.
ANTIAGE GENOME will not, in any case, be responsible for the veracity of the statements made by those declaring themselves to be holders of parental authority or guardianship of the minor for whom any of the services described on the website are contracted. ANTIAGE GENOME will also not be responsible for verifying the authenticity of the documentation provided by those contracting on behalf of the minor. ANTIAGE GENOME will only maintain communications with adult users.
To acquire services from ANTIAGE GENOME, the user is only required to fill out the registration form with the necessary information, follow the on-screen instructions to select the desired service, and once these General Conditions and the purchase summary detailing the service(s) to be acquired have been accepted, provide the payment information – depending on the payment method available in each case. The information provided by the user to ANTIAGE GENOME during the contracting process must be complete, true, and up to date.
Purchasing this item implies the obligation to return the sample from the same country where the purchase was made. If this is not the case, please contact us via email at [email protected] as it may incur additional costs.
Once ANTIAGE GENOME has confirmed the payment made by the user, the user will receive a confirmation email within a maximum of 24 hours, informing them of the completed purchase and providing the steps to follow in each case. If, exceptionally, the purchasing user does not receive the confirmation email within the maximum period of 24 hours, they should contact ANTIAGE GENOME to report the issue at the email address [email protected]. In any case, before formalizing the purchase and/or using other services such as the forum, the user must accept the conditions, which will always be available on the website through which the purchase was made.
Furthermore, by acquiring any service from ANTIAGE GENOME, the user accepts and guarantees: (i) that the saliva sample provided is from the user themselves or the person on whose behalf the service has been contracted and that no regulations prohibit them from providing such a sample; (ii) that the user does not work for or is not related in any way to insurance companies, healthcare providers, or any other third parties who might have commercial interests in knowing the results of the service contracted with ANTIAGE GENOME; and (iii) that they do not acquire the service from ANTIAGE GENOME with the intention of reselling, copying, reproducing, or exploiting it commercially in any way, nor with the intention of criticizing, harming, or performing any actions contrary to ANTIAGE GENOME and its activities.
The prices in effect at the time the purchase is made are those that appear on the screen (including applicable taxes in each case) on the summary page prior to finalizing the purchase, except for typographical errors. Prices will be adjusted for each country according to logistics and other variables considered, such as the number of samples to be processed together, priority, etc.
About us
Licensed by:
Center For Medical & Medicaid Services. Clinical Laboratory Improvement Amendments. Florida, USA.
Certificate Accreditation by:
Department Of Health Division Of Medical Quality Insurance. Florida, USA.
Cola. Florida, USA.
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