The DNA testing industry in the United States has enjoyed massive growth, especially when you consider applications like ancestry tracking, health risk assessments, and in recent years, legal paternity tests.
Howbeit, it is necessary to point out that this industry is stringently regulated due to the sensitive nature of genetic data as well as its implications for health, privacy, and legality.
Keep in mind that to start a business that offers DNA testing services, it is pertinent that you acquire some essential certifications, carry out certain important training, and stay in line with federal and state regulations. If you want to start a DNA Testing Business or offer similar services, below are the top certifications to obtain.
Certifications Needed to Operate a DNA Testing Business
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Clinical Laboratory Improvement Amendments (CLIA) Certification
This is a federal requirement meant for all laboratories that offer services relating to clinical testing on human specimens, such as DNA tests. The primary essence of this certification is to guarantee the accuracy, reliability, as well as timeliness of test results.
Training and Education
- Laboratory Director: The lab director is expected to first possess a doctoral degree in laboratory science or a related field as well as have verifiable experience in laboratory management. The individual is also expected to have obtained specialized training in quality control and laboratory regulations.
- Laboratory Technicians: Technicians will need to obtain relevant degrees (e.g., biology, genetics, or medical technology) as well as take part in certain vital training relating to DNA testing procedures, equipment handling, as well as adherence to CLIA regulations.
Certification Process
- Evaluate Your Lab’s Complexity Level
- Send in Your CLIA Application
- Pay the Necessary Fees
- On-Site Inspection
- Certification Issuance.
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State-Specific Laboratory Licensure
Aside from the federal CLIA certification, a good number of states have put in place specific licenses for laboratories, especially those that offer genetic or molecular testing.
Training and Education
Note that training and education requirements tend to vary from one state to another. While the extent applicants will be expected to go will largely depend on state regulations, it is pertinent to point out that it will most likely include adherence to state-specific laboratory standards, and this can warrant additional coursework or professional development.
Licensing Process
- Research State Regulations
- Send in Your Application
- State Inspection
- Obtain Licensure.
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American Association of Blood Banks (AABB) Accreditation
Although this particular accreditation is not considered mandatory in a good number of states in the United States, note that it is well renowned especially when it comes to laboratories that provide services that involve relationship testing, such as paternity tests. It is meant to indicate a business’s conformance to stringent standards in testing and laboratory operations.
Training and Education
Lab Directors and Personnel: These individuals are expected to possess a substantial foundation in laboratory sciences, with other training focused on AABB standards, quality management, and best practices in genetic testing.
Accreditation Process
- Be certain that your laboratory’s procedures fall in line with AABB standards.
- Apply for AABB accreditation, ensuring all required documentation is attached.
- Carry out a self-assessment or seek an external review to guarantee full compliance.
- AABB will send assessors to inspect and analyze your lab’s practices and procedures.
- Once you scale through the assessment, your lab will obtain AABB accreditation.
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ISO 17025 Accreditation
It is an international standard for testing and calibration laboratories. Note that it is obtained by labs that have an interest in getting international recognition or catering to the needs of international clients.
Training and Education
Laboratory Personnel: It surely necessitates a background in laboratory sciences, with valid training in quality management systems (QMS), technical operations, and ISO 17025 requirements.
Accreditation Process
- Document procedures that fall in line with ISO 17025 standards.
- Forward your application to a recognized accrediting body.
- Carry out a well-detailed internal audit to note areas of improvement.
- Take part in a formal assessment by an accrediting body’s auditors.
- Once you pass the audit, your lab will be granted ISO 17025 accreditation.
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Genetic Counseling Certification (For Labs Offering Counseling Services)
This is particularly essential for DNA testing businesses that offer among other things services like genetic counseling. Note that this certification can only be obtained through the American Board of Genetic Counseling (ABGC) or a similar organization. This will prove to clients that your services align completely with high professional standards.
Training and Education
- Educational Background: Most often, individuals are expected to possess a master’s degree in genetic counseling from an accredited program.
- Certification Exam: Candidates will also need to scale through a certification exam administered by the ABGC or another recognized body.
Certification Process
- Acquire a master’s degree in genetic counseling.
- Send in all stipulated documentation to be sure you qualify for the exam.
- Study and ensure you pass the certification exam.
- Take part in continuing education to keep your certification current.