Company Information

ViroGene is one of the leaders in molecular diagnostics, offering a wide range of products and services in the field of molecular testing. We have a unique capacity in people and technology to provide innovative, cost-effective, timely, and reliable solutions in biomedical research and laboratory diagnostics.

All over the world, we are dedicated to working with our customers – researchers, clinicians, and patients to help them meet their individual needs. ViroGene plays a pioneering role in personalized healthcare and stays ahead in providing products tailored to the needs of specific patient groups.

We operate a state-of-the-art molecular facility in Egypt with a team of scientists dedicated to the best quality and design control practices. Molecular products are manufactured under good manufacturing practices (GMP) and ISO 13485:2016 Certification. Various product labeling standards, including RUO, ASR, CE, and IVD, are developed and released under the appropriate design control and launched per any country’s specific regulatory requirements.

ViroGene has constructed facilities to meet the unique requirements for amplified nucleic acid testing. A high-quality standard is maintained through continuous investment in process improvements and a team of technical specialists who help to ensure optimal performance during development and product release stages.

History

ViroGene Diagnostic Industries Products is an Egypt-based firm. The company was founded in 2022 to make custom nucleic acid tests more widely available and enable the widespread usage of molecular diagnostics with the potential to benefit society. ViroGene Diagnostic Industries Products has some of the most capable scientists in the world with extensive experience in the respective field.

Following this tradition, the ViroGene Diagnostic Industries Products team is actively developing and commercializing new molecular diagnostic assays – fast, flexible, reliable, and close to customer needs.

ViroGene Diagnostic Industries produces a growing portfolio of tests for infectious diseases. Genetics, Oncology, Oncogenetics, and Nucleic Acid Extraction, whether Manual or Automated.

 

Quality Policy

The Management of ViroGene Diagnostic Industries is operating under the control of a quality management system along the lines laid down in ISO13485:2016 standards.

The Company places particular emphasis on obtaining client satisfaction by:

• Responding promptly and accurately to customer inquiries and orders.

• A constant pursuit of quality, value, and reliability in the products and services the Company supplies to its customers.

• Ensuring its management and staff are fully trained to meet the business’s and its customers’ requirements.

• Constantly striving to meet customer requirements and monitoring information and experience related to products.

• Working closely with its customers and establishing the highest quality standards.

• Adopt a forward-looking view of future business decisions that may impact quality.

• Train all staff members in the needs and responsibilities of quality management. To meet the Customer’s specified requirement (Clients, interested parties, Top Management, and Statutory and Regulatory Agencies), the Company applies a quality management system in conjunction with other management controls; this is described in the Quality and Procedure Manuals.

Responsibility for upholding this policy is Company-wide under the guidance and assistance of senior management, who encourage the personal commitment of all staff to address quality as part of their skill base.

The Company’s policy is to continuously seek to operate to these standards and implement and operate the ISO13485:2003 bar through registration and annual review.

The Company provides in-vitro diagnostic medical devices compliant with all applicable legislation, statutory and regulatory requirements relevant to its industry, and health and safety regulations. It seeks full implementation and ongoing maintenance of the effectiveness of its management system.

 

Code of Business Conduct and Ethics

Policy

It is the policy of ViroGene Diagnostic Products to require the highest standards of business ethics and integrity on the part of all employees and to comply with all applicable laws and regulations in the conduct of its business. To that end, ViroGene has adopted and implemented this Code of Business Conduct and Ethics.

All directors, officers, and employees of the Company are responsible for reviewing this Code and certifying annually that they have reviewed and is in compliance with the Code.

Failure by an employee to comply with this Code will result in appropriate disciplinary action, which may include termination of employment. Unless the context requires otherwise, all references to “employees” in this Code shall also refer to officers of the Company.

Scope

This Code applies to all ViroGene’s directors, officers, and employees worldwide.

Compliance With Laws And Internal Policies

The Company requires that all employees, officers, and directors comply with all laws, rules, and regulations applicable to the Company wherever it does business. You are expected to use good judgment and common sense in seeking to comply with all applicable laws, rules, and regulations and to ask for advice when you are uncertain about them. If you become aware of or have reason to believe there has been a violation of any law, rule, or regulation by the Company, whether by its officers, employees, or directors, you are expected to promptly report the matter to your supervisor, a member of the Company’s Legal Department, or contact the Ethics Committee. Employees, officers, and directors shall not discharge, demote, suspend, threaten, harass or in any other manner discriminate or retaliate against an employee because They report any such violation or belief in good faith.

In addition to laws and regulations imposed by local governments and regulatory bodies, the Company adopts its own policies and procedures from time to time. As in the case of rules and regulations, you are also required to comply with the Company’s internal policies and procedures.

Acceptance Of Costly Entertainment or Gift

In general, Company employees, officers and directors, and their relatives may not request or accept payments of money or anything of value from any government officials, customers, suppliers, or others with whom the Company does business, has done business, or may have occasion to do business. Restricted payments include, but are not limited to, any of the following:

1. Compensation (cash, kind, credit, etc.).

2. Travel, transportation, or lodging.

3. Entertainment including, but not limited to, tickets to sporting and other events, business meals, and other business-related entertainment activities (golf, tennis, etc.) unless approved in advance by your supervisor or a member of the Company’s Legal Department or ancillary to a legitimate business meeting attended by the person or company providing the entertainment.

4. Gifts of any kind, nature, or description, including discounts, coupons, and other offers not available to the public in general, provided, however, that employees may accept branded promotional items and annual holiday gifts (other than cash) having a reasonably estimated fair market value of $100.00 or less, provided the facilities are consistent with customary industry practices and applicable law. They could not reasonably be construed as a bribe or payoff. For guidance on gifts that do not meet this criterion, please get in touch with a Company’s Legal Department member.

Honest And Ethical Conduct and Fair Dealing

Employees, officers, and directors should endeavor to deal honestly, ethically, and somewhat with the Company’s suppliers, customers, competitors, and employees. Statements regarding the Company’s products and services or otherwise must not be untrue, misleading, deceptive, or fraudulent. It would help if you did not take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts, or any other unfair-dealing practice.

Equal Employment Opportunity

ViroGene’s policy is to afford equal employment opportunities to all individuals of any race, color, religion, sex, national or ethnic origin, sexual orientation, disabled veteran or veteran of Vietnam era status, and age with due regard to their relative qualifications and abilities. ViroGene’s Equal Employment Opportunity Policy applies to recruitment, hiring, promotion, demotion, transfer, discipline, layoff, termination, rates of pay, selection for training, and every other type of pre- and post-employment personnel activity.