New Graduate Program Proposal
Master of Science in Clinical Molecular Genetics
School of Clinical Sciences: Clinical Laboratory Sciences Programs
Rationale
The Clinical Laboratory Sciences (CLS) programs propose to offer a graduate program leading to a Master of Science Degree in Clinical Molecular Genetics. There has been profound growth in the molecular diagnostics market in healthcare. Molecular tests are utilized with increasing frequency in areas of medicine including genetic disorders, infectious diseases, detection and monitoring of cancer, pharmacogenomics, and identity testing. The future of healthcare will rely on genomic medicine for diagnosis, prognosis,monitoring the course of disease, and selecting optimal treatment strategies.
Diagnostic molecular scientists require specialized training and the demand for these professionals is great. NMU is one of eight universities nationwide that offers an accredited program in Diagnostic Molecular Science at the baccalaureate level. The accredited program by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), coupled with the fact that Molecular Diagnostics is the fastest growing area of the clinical laboratory, provides the framework and opportunity to expand our program to the Master’s level.
The proposed MS program will be offered through online coursework with an on-campus laboratory experience. There will be two tracks. The professional, project-based, track will appeal to working professionals. Molecular assay development and validation projects can be completed at their place of employment under the tutelage of NMU faculty. A research, thesis-based, track will be appropriate for those seeking research positions in industry including pharmaceuticals, biotechnology, government, and academe.
The MS degree program will be highly desirable to Biology and CLS BS graduates as it will provide professional growth opportunities in health care and related industries. The program will bring increased national visibility to NMU which will likely result in enrollment increases at both undergraduate and graduate levels.
Description of Curriculum
The Master of Science degree program in Clinical Molecular Genetics will provide coursework and training in molecular-based clinical diagnostics. Graduates will perform and interpret molecular diagnostic testing and explain the clinical utility to health care professionals. Coursework for the Clinical Molecular Genetics program will be offered online allowing working professionals’ flexibility in scheduling. A one week experience in the Molecular Diagnostics laboratory on campus will be included. Students will have the option of choosing the professional project-based track which involves method verification and validation, or a clinical research track with the completion of a thesis.
Program Goal: The Master’s degree in Clinical Molecular Genetics will prepare graduates for professional roles as practitioners, researchers, and educators in clinical molecular diagnostics.
School Mission Statement: The mission of the School of Clinical Sciences is to educate future clinicians. We seek to engage students in innovative, problem-based learning, preparing them to serve the regional and global community with skill and compassion.
The proposed program is in congruence with the mission statement by providing a graduate curriculum that is relevant to current healthcare trends. The School fosters innovative ways to provide instruction as exemplified by the online nature of the proposed program.
Program Objectives: Graduates of the program will
- Select, interpret, and implement molecular-based clinical assays
- Communicate the appropriate clinical use and significance of molecular-based tests to other health care professionals and the public
- Establish and validate novel molecular methods for clinical use
- Interpret, implement, and comply with laws, regulations and accrediting standards of governmental and non-governmental agencies
- Apply principles of management to biomedical laboratories
Job Opportunities for Graduates
Job opportunities for graduates are found nationwide in healthcare including hospitals and public health departments, reference laboratories, state and federal law enforcement agencies, biotechnology industries,pharmaceutical companies, research institutions and academe.
The US Bureau of Labor Statistics dataidentify a 13% increase in the need for clinical laboratory scientists between 2010 and 2020. The specific data regarding personnel trained in Clinical Molecular Genetics is not cited as this is a relatively new and emerging diagnostic field. The rapid growth in Molecular Diagnostic testing is exemplified by the number of molecular genetic tests currently available at Mayo Clinic (NMU affiliate in the accredited Diagnostic Molecular Science BS program). The Mayo Clinic website ( currently lists 422 types of molecular-based clinical assays available with the menu of diagnostic test growing each month (Mayo Clinic Communique). The large menu of diagnostic tests coupled with the lack of qualified graduates exponentially increases the need for trained personnel according to the American Society for Clinical Pathology.
Reports from laboratories performing clinical molecular testing indicate that it is difficult to find personnel to fill current position. Job postings for graduates trained in Molecular Genetics can be found on websites for the following organizations: Association for Molecular Pathology, Association of Genetic Technologists, American Society for Clinical Pathology, American Society for Microbiology, and American Society for Hematology.
The results of the 2012 Advance Laboratory salary survey for laboratory professionals offered insight to professionalopportunities in clinical molecular genetics. The average salary of those that specialize in Molecular Diagnostics/Genetics was $80,760. The Pacific region (AK, HI, CA, OR, WA) offers the highest salaries, followed by the Middle Atlantic (NJ, PA, NY) and New England (VT, NH, CT, MA, RI, ME).
Related Programs at NMU
The CLS programs offer a BS program with a concentration in Diagnostic Genetics: Diagnostic Molecular Science. This NAACLS accredited program continues to have excellent outcomes for the BS graduate. The proposed master’s program will provide the opportunity to earn the Master’s degree in the rapidly expanding field of Clinical Molecular Genetics.
Comparison to Other Universities
Several universities in the region offer MS degree programs in Cell and Molecular Biology that prepare students for research careers. These programs are offered as traditional, on- campus programs that typically include a thesis. The proposed program is unique in its focus on the clinical application of Molecular Genetics. The online program will appeal to both working professionals as well as traditional students interested in earning a Master’s degree. The employment opportunities in a variety of venues will be highly valued. The MS degree will also give students unique training for those pursuing doctoral degrees.
Accreditation
The proposed degree program will not be subject to professional accreditation standards. Graduates of the program will be eligible for national certification in Molecular Biology from the American Society for Clinical Pathology with six months of experience in a clinical molecular genetics laboratory.
Graduate Bulletin Listing
The Master of Science in Clinical Molecular Genetics is offered to those interested in professional opportunities in clinical molecular diagnostics for healthcare, biotechnology, pharmaceuticals, forensics, research and academe. Students complete online graduate courses and one week in a molecular diagnostic lab experience on campus. Students will perform research or a method verification and validation which will culminate in a Thesis or Project, respectively. The Thesis or Project will be presented as a seminar at the conclusion of the program.
Students will take the following courses.
CLS 520Principles of Clinical Molecular Genetics3 credits
CLS 526Clinical Molecular Diagnostic Techniques 4 credits
CLS 536Clinical Genetics3 credits
CLS 541Clinical Applications of Genomic Medicine3 credits
CLS 543Molecular Diagnostics in Identity Testing2 credits
CLS 544Molecular Diagnosis of Infectious Disease3 credits
CLS 560Biomedical Laboratory Operations3 credits
CLS 563Research Design and Methods3 credits
CLS 570Method Verification and Validation4 credits
CLS 580Project in Clinical Molecular Genetics4 credits
CLS 599Thesis in Clinical Molecular Genetics4 credits
Total Credits: 32
Admission Requirements
Applicants are required to comply with the regular admission requirements of the Office of GraduateEducation and Research, which includes an undergraduate grade point average of 3.0. In addition, students must have a Bachelor’s degree in Clinical Laboratory Science or Biology. Transcripts of applicants will be evaluated on an individual basis.
In cases where the undergraduate GPA is below 3.0, additional factors, including 2 years of clinical laboratory experience or performance in the last 60 hours of course work, may be weighted more heavily in the assessment for admissions.
Applicants should have coursework in genetics, hematology, microbiology, immunology, molecular biology, chemistry, and statistics. Laboratory experience is required. This requirement can be met by documenting one year of clinical laboratory experience or 16 credits of courses accompanied by a lab. Students may be admitted with deficient backgrounds if coursework is met in a defined period of time.
Applicants are required to comply with the regular admission requirements of the Office of Graduate Education and Research. In addition:
- Applicants must submit three letters of recommendation from instructors or professional references. Letters should address the applicant’s academic and professional abilities and preparation for graduate study.
- A statement of intent must be included which describes the applicant’s laboratory skills and experiences, and reasons for pursuing graduate education.
Graduation Requirements
Students must complete all courses listed and a Project or Thesis.
New Course Descriptions
All courses in the program are new. The description for each new course, course number, name, credit hours, prerequisites, rationale, grading, outline, goals and student outcomes are provided on pages 7 – 26.
Projected Enrollment
We anticipate enrollment in year one would be 10 students with 20 students in year two. Enrollment in each subsequent year is projected at 15 – 20 per year for a total enrollment of 30 – 40 per academic year.
Costs
Staff
All of the courses in the program are new and will be offered online. Compensation for online course development for initial offering would be as additional assignments.
Provost Lang has approved an enhancement position for the CLS programs with a national search currently underway. It is expected that the new faculty position will teach courses in the graduate program according to background and experience. Current faculty, Dr. Mary Stunkard, Dr. Linda Riipi and Assistant Professor Catherine Bammert, have qualifications to develop and teach courses in the proposed graduate program. Current faculty with the addition of the enhancement position are adequate for the initial offering of the graduate program.
Two courses for a total of six credits will be offered in the Summer semester. Costs associated with summer staffing will be in accordance with the guidelines in the Agreement.
Equipment
Equipment that will be needed to accommodate ten students in year one of the program are detailed below. This is in addition to the equipment currently available in the CLS Molecular Diagnostics Laboratory (Appendix A).
Roche Light Cycler 2$25000
LightCycler Centrifuge$3,500
Inverted Microscope$15,000
ELP “Mini-Sub” Chamber (10)$3176
ELP “Wide-Sub” Chamber (10)$4024
Nucleic Acid Workstation (2)$8000
Micropipettes (set of 24 of 4 volumes)$11,050
Microtome$10,000
Supplies
Yearly supplies for the on campus experience in the Molecular Diagnostics Laboratory are estimated to be $4500. An additional $750(per student) will be needed for consumables for students choosing the on campus research and thesis track.
Library
Current library resources are adequate for this online program.
Space
All courses will be online with the exception of CLS 526 which includes a one week experience in the Molecular Diagnostic Laboratory on campus. Current laboratory space can accommodate up to ten students.
Staffing Plan
The approved enhancement position for the CLS programs along with current faculty will be adequate to staff the courses for the proposed program in Year 1. In Year 2 of the program, additional adjunct faculty may be needed dependent on enrollment. The total additional credit hours of courses offered in Year 2 is 13 credits per semester. The summer course offerings will require additional summer salary.
Equipment
Current equipment that is available for the proposed program is described in Appendix A. Additional equipment needs are outlined above under ‘Costs’/’Equipment’.
Library Usage
Given that the courses in the proposed program are offered online, library usage will likely be through online resources. In addition to online journals and books, the Library Distance Education Services provide photocopying of print journal articles not available online. The Clinical Sciences library liaison, Mike Strahan, has been consulted regarding the library resources needed.
Space
The online program requires space for the one week laboratory experience in the CLS Molecular Laboratory which is adequate for ten students. This area may also be utilized by students choosing the research track. Occasionally there may be a working professional who is unable to complete the required scholarly project at their place of employment. We anticipate adequate space for these activities.
Program Delivery
Fall Year 1 / Winter Year 1 / Summer Year 1 / Fall Year 2 / Winter Year 2CLS 520 Principles of Clinical Molecular Diagnostics – 3 cr / CLS 541 Clinical Applications of Genomic Medicine – 3 cr / CLS 526 Clinical Molecular Diagnostic Techniques – 4 cr / CLS 563 Research Design and Methods – 3 cr / CLS 560 Biomedical Laboratory Operations – 3 cr
CLS 536 Clinical Genetics – 3 cr / CLS 544 Molecular Diagnosis of Infectious Disease – 3 cr / CLS 543 Molecular Diagnostics in Identity Testing – 2 cr / CLS 570 Method Verification and Validation – 4cr / CLS 580 Project in Clinical Molecular Genetics – 4 cr
OR
CLS 599 Thesis in Clinical Molecular Genetics – 4 cr
The program will be offered with online courses with the exception of the one week campus laboratory experience in CLS 526. Students opting for the research track will conduct their research on campus while working professionals will likely complete the scholarly project at their place of employment.
The table above provides the opportunity for program completion in two academic years with the required summer semester enrollment. The program also allows for part-time enrollment.
Implementation Date
The goal is to offer the program beginning in Fall 2014.
New Course Proposal
Bulletin Description
CLS 520 Principles of Clinical Molecular Diagnostics,3 credits, online
Concepts and principles of current molecular technologies will be examined with applications to clinical diagnostics.
Prerequisites: Admission to MS program in Clinical Molecular Genetics
Grading: Letter grade (A-F)
Rationale: Course is a foundation course for subsequent courses in the degree program. This is a required course for both project and thesis tracks.
Course Outline:
Separation and Detection Techniques
Gel and Capillary Electrophoresis
Probe Hybridization
Nucleic Acid Purification
Probe Structure
Nucleic Acid Amplification
Polymerase Chain Reaction (PCR)
PCR Variations (real-time, nested, multiplex, arrays, reverse transcriptase)
Branched DNA Technology (bDNA)
Sequence Based (NASBA)
Transcription-Mediated Technology (TMA)
Strand Displacement Amplification (SDA)
Loop- Mediated Isothermal Amplification (LAMP)
DNA Sequence Analysis
Sanger Sequencing
Next Generation Sequencing
Automated Sequence Analyzer
Melt Curves Analysis
In-situ Hybridization
Restriction Fragment Length Polymorphism
Multiplex Ligation-Dependent Probe Amplification (MLPA)
Quality Assurance and Control
Course Objectives:
- Compare and contrast major molecular technologies
- Discuss the theory for each molecular technology
- Apply the theories to the clinical assays used
- Describe quality control for molecular-based assays
- Diagnose clinical assay failures
Evaluation Methodologies: Evaluations include online assignments that will be submitted individually or by group participation. Assignments may be given in a variety of formats such as short papers, case studies, and laboratory problems. Exams will be administered online consistent with the course objectives.
Staffing: Course can be taught by current faculty with Molecular Biology(MB) certification by the American Society for Clinical Pathology (ASCP) or enhancement faculty position (approved).
Equipment and Supplies: Online course so no equipment and supplies needed.
Library Holdings: Current library resources are adequate.
Costs: Faculty course load.
Effects on Other Departments: No effects on other departments are anticipated.
Implementation Date: Fall 2014
New Course Proposal
CLS 526 Clinical Molecular Diagnostic Techniques, 4 credits, online and one week (40 hours) campus molecular laboratory
The techniques course will provide students with clinical molecular decision making strategies required for diagnosis, prognosis and management of human disease.
Prerequisites: CLS 520
Grading: Letter grade (A-F)
Rationale: Under the direct supervision of experienced and certified molecular biology technologists, students will learn to perform procedures using analytical methodology in a clinical molecular laboratory. The course will link to the principles learned in CLS 520 to clinical molecular techniques. The course will utilize online tutorials prior to the campus laboratory experience to maximize learning. Course will be required in both project and thesis tracks.
Course Outline: The course will provide participants with hands-on laboratory experience in performing molecular techniques such as DNA extraction, purification and quantification; preparing and viewing PCR products; interpreting DNA fingerprints via gel and capillary electrophoresis. Students will also perform advanced molecular methodologies such as cell culture techniques, melting curve analysis, Southern blot analysis, and fluorescent in-situ hybridization.
Tutorial sessions will be completed prior to the campus laboratory experience to prepare students for intense hands-on training. Online topics will include: RNA isolation, analysis of expression, PCR, preparation of DNA, RNA and probes, cDNA synthesis (RT-PCR) and analysis, Southern, Western and Northern Blots, microarrays and gene chips, and Real-Time-PCR.
Course Objectives: Upon completion of the course, students will be able to:
- Perform DNA and RNA extraction and purification methods on a variety of specimens, including blood, tissue cultures, and formalin-fixed, paraffin-embedded tissue. Quantify products mathematically and using the Nanodrop instrument.
- Demonstrate proper storage and retrieval of tissue cultures and extracted nucleic acids.
- Perform micro-dissection of formalin-fixed, paraffin-embedded tissue prior to performing DNA extraction and discuss the rationale for doing so.
- Utilize restriction enzymes to perform RFLP-PCR and analyze the DNA fingerprint following agarose gel ELP.
- Prepare and perform PCR reactions and explain ways to optimize the reaction.
- Perform Real-Time PCR using FRET probes and capillary electrophoresis.
- Perform melting curve analyses.
- Perform FISH and interpret fluorescent imaging
- Comply with the essential elements of a QA/QC program for the Molecular Lab and CAP/Joint Commission standards required for accreditation.
Evaluation Methodologies: Evaluations will include online assignments that may include short papers, case studies and laboratory problems. Laboratory evaluations assess accuracy, efficiency, problem-solving, and organization.