President's Corner

Novel Program Yields Success and Satisfaction in Training for Molecular Diagnostic Careers

IMG_0174Over the last three years, BayBio has helped to recruit sites for an innovative program designed to address the demand for Clinical Lab Scientists (CLS). Fueled by personalized medicine’s promise to revolutionize the medical field, CLSs are in high demand and an important member of the diagnostic community.

With support from a federal Department of Labor Employment and Training Administration Stimulus grant, San Jose State University (SJSU) and California State University, Los Angeles, embarked on the novel pilot to train professional lab scientists to perform molecular diagnostic tests.

Six sites in the Bay Area stepped forward to help train students for a Clinical Genetic Molecular Biologist Scientist (CGMBS) certification. For the last year-and-a-half, Hunter Laboratories, Siemens Medical Solutions Diagnostics, San Mateo County of Public Health, Veracyte Inc. and XDx Inc., have trained and are training a total of 11 interns.

As intern hosts for 32 hours per week for 52 weeks, each site is required to be CLIA-certified, the federal designation required to ensure quality in molecular diagnostic testing. Participating intern hosts and students alike have sounded high praise for the program.

“The experience has been fabulous for us,” stated Michaela Hart, a Sr. Director at Veracyte, a South San Francisco-based molecular diagnostics company whose first product is designed to reduce unnecessary surgeries as part of thyroid cancer diagnosis. Many of the participating companies shared this sentiment. In spite of this mutually beneficial experience, however, the university has had to turn students away each year because of the lack of clinical host sites.

While some sites have opted to host their interns for the full 52 weeks, Veracyte and XDx agreed on an internship rotation that would allow students to gain a fuller breadth of test experience.  During the first year of the pilot, each site took two interns for six months. This year, each are hosting two interns – one for the first six months, another for the second six months – with the goal of giving more experience to more interns.

Interns are adding significant value to their host sites. Intern hosts have been very impressed with the caliber of students and the cumulative experience they bring. Cindy Chan, a previous intern at Veracyte, now interning at XDx, graduated with a BS in clinical science from SFSU, and worked at Tethys and Genentech before entering the CGMBS program.

Another recent graduate of the program, Malcolm Shields came to the Bay Area three years ago after 22 years as a tenured faculty in a CLS program at Idaho State University. His MLS certification was not recognized when he moved to the state of California, so Malcolm entered the CGMBS program. Having completed the program and licensure last summer, Shields was hired by Siemens as a staff scientist in the tech transfer division and now coordinates other interns in the CGMBS program.

“The students are extremely valuable in what they bring to the company,” he said. “They are hardworking, intelligent, problem-solvers, and are extremely dedicated. They bring new perspectives and new sets of tools from their didactic experience. ”

Added Veracyte’s Hart: “They function as a fresh set of hands, eyes and ears, bringing valuable suggestions.” This is particularly so in the case of CI (Continuous Improvement), a significant part of the CLIA world.  Interns provide valuable CI ideas “from the bottom up.”

The caliber of the students is matched by the dedication of the intern supervisors.  Shields rotated each of Siemens’ three interns through all twelve of the company’s tests.

“My goal is to train as broadly as possible to ensure their marketability,” said Shields.

Similarly, Hart works to “close the gap” between the generalist Clinical Laboratory Scientist training and that of the CGMBS.  In what she calls her SPROUT program – Sprouting new lab scientists – Hart asks students to  [S] come up with special projects aligned with their interests and passions;  [ROU] know the routine lab operations;  and [T] be able to run the tests.

“Testing is important, but so are things like performing proficiency testing, sending pipettes off to be calibrated, etc” Said Hart. “I want our interns to understand what it takes to run the entire lab, and not just the tests, so that they will have full marketplace options after becoming certified.”

Jennifer Clarke, who finished her rotation at XDx and has now moved on to her rotation at Veracyte, exclaimed: “I’m working along with other professional lab scientists and am pulling my weight.”

Having entered the program with a BS in Genetics from UC Davis and experience working at Cedars Sinai, Jennifer was excited to learn the AlloMap gene expression test for acute rejection of heart transplants at XDx.

Veracyte and XDx and their interns have been pleased with the success of the intern rotations.  “I’m very curious to see how various labs work, which the rotation allows,” said Cindy Chan.

Hart believes the model brings value to both companies.  “By sheer essence of the rotation itself, the interns are helping to harmonize best practices among the participating companies,” said Hart.

Students also participate in eight hours per week of in-person or virtual didactic training from SJSU, lauded by both students and intern hosts.

“The virtual lectures support all the methods we use at Veracyte,” stated Chan.

Shields said that SJSU has done an excellent job in putting the info online, making it available, thorough, timely and on target.

Hart added that it is critically supportive of Veracyte’s training.

All of the students from the first year have found jobs, two of them at their intern sites.  “I would like for more students to take advantage of the program,” stated Chan, “There are so many opportunities in the science field. Molecular diagnostics is the new frontier”

Veracyte intends to continue with the program.

“We’ve been very pleased,” said Hart. “I’ve only seen gains from this experience.  We plan to continue and will stick with the rotation.”

“New minds and new technologies will only help what we are doing,” add Shields.

As part of its effort to increase the number of training sites, SJSU continues to help interested CLIA certified companies become approved training affiliates by helping with the required application to Laboratory Field Services (LFS), the state’s oversight office.  Sue Gayrard, director of the CGMBS program at SJSU encourages interested companies to contact her as soon as possible to participate in this dynamic program next fall: “The more sites we have, the more students we can take.  If companies have CLIA-certification, we can still help them get LFS approval in time for the fall semester!”

For more information about the CGMBS program please contact Sue Gayrard at San Jose State University:

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