Micaela Vargas’ Credentials

Micaela Vargas (Micki) has a PhD in cell and molecular biology. Part of her work as a Doctoral student at the University of Texas at San Antonio (UTSA) was identifying and characterizing novel anthrax toxin receptors and analyzing these genes in patient-specific prostate cancer. Her research project encompassed molecular biology, cell biology, and molecular genetic techniques and applications. She graduated with a PhD and did her postdoctoral fellowship at the University of Illinois at Chicago (UIC) in regenerative medicine specifically utilizing stem cells as a therapeutic application for cardiovascular disease and lung injuries. In addition to her independent projects, she managed the molecular biology (PCR) core in the Department of Pharmacology.

Many of the platforms she was using at that time are currently being used in labs today. And because of that, Micki understands and knows the market well as far as instruments, applications, reagents, and what clinical tests are needed. When Micki made the move several years ago to San Antonio where she currently lives, she built a highly successful Pharmacogenomics (PGx) company. Micki built the lab, pulling from her vast array of experiences and her expertise in molecular biology and diagnostic work. She designed the lab, and at the same time developed a novel clinical diagnostic test for pregnant women who may have an inherited gene(s) for Cystic Fibrosis (CF). The current CF tests are invasive blood draws and or amniocentesis. Similar to PGx testing, CF is a simple buccal swab designed to test pregnant women and assess their genetics to determine if the fetus tests positive for CF. In addition to PGx and CF tests, Micki partnered and collaborated with a Key Opinion Leader (KOL) and developed  a nutrigenomics panel, specifically for patients that have familial or show signs of mental health disorders. 

For the past 3 years, Micki has served as an independent consultant helping academic laboratories, industry, and clinical startups with test methods, development of new ideas/technologies, designing experiments, innovation, collaborations, and build outs according to clientele needs. Many startups don’t have any experience with building labs, specifically molecular laboratories. So Micki helps to build out ideas and understand future goals of the company. Some of these labs have been established for some time, wherein she helps their team beyond just PGx testing (such as next generation sequencing (NGS), oncolytics, and infectious disease).

Reimbursements & Coding: A Hot Topic in Genomics Today

  • Reimbursements & Coding – For genomics labs, there were major changes in billing codes this past Fall, which can be very stressful transition for labs. Especially important for for-profit companies, your lab needs to ensure you are using the correct ICD codes for reimbursements. Micki encourages molecular labs (PGx, NGS) to check out the federal government resources, such as seminars and education events, to learn more about the new ICD codes and tests these are associated with. Other resources include, societies such as the Association of Molecular Pathology (AMP) and College of American Pathologists (CAP) that are also up to date with any changes, technologies, and advancements in testing.

How should PGx/Genomics Labs Prepare For Changes?

Right now, PGx is a very hot topic across the healthcare space and because of this, many labs are adding pharmacogenomics in addition to other testing platforms. Being part of the PGx and molecular diagnostic community, Micki advises that it’s important to not just focus on one testing panel – your lab needs to be diverse, otherwise you will be quickly outrun by more agile labs who have more resources and more testing capabilities.

NGS has been around in basic research for a while, and the crossover clinically has been gaining popularity. Because NGS is a powerful molecular biotechnology, Micki advises clinical labs to invest in these platforms. Micki also notes that many Pgx labs will join together with toxicology labs, which helps both diversify their offerings. A Pgx lab may not be suited for a tox lab and vise versa, so these labs will join together and do each other’s testing to broaden the amount of tests they can run.

Another aspect with labs and testing, Micki notes, is a very important piece of advice:

“It’s crucial that startup labs have a team member with a very strong molecular background. Some labs without experience have hired “ill-equipped personnel” to help them market their lab and tests. My advice is to have at least a scientist with a strong molecular background and a supportive team. In addition to that, because these are patient testing labs, it’s very important to know compliance – especially for lab accredited (COLA, CAP, CLIA). Many labs also use a consultant who knows compliance and rules for both Federal and State regulations.”

What Are the Most Important Technologies a Lab Can Adopt?

  1. A LIMS and Reporting Platform: It’s important for labs to be on the cutting edge of technology. Not only does it equip labs to be more efficient and reduce errors, but many technologies help to improve the patient experience directly. Micki advises that labs adopt a LIMS system like Pathagility first and foremost. Streamlined processes is one of the main improvements a lab needs to invest in, and a LIMS system is the first step in doing so. According to Micki, Pathagility is a great technology platform as the LIMS and Reporting software can organize lab, accessioning, and reporting to the specific lab, and branding is tailored and custom to represent the lab’s identity.
  1. Robots & Liquid Handlers: In addition, one thing very important for scaling samples and high-throughput is using robots or liquid handlers (such as Hamilton, which has been the forefront of liquid handling and are in many Tox and Pgx labs across the country). These liquid handlers streamline everything in terms of handling the material. The consequence of not using this type of technology is an increase of errors, longer turnaround times (TAT), and rerunning samples.

Micki’s Personal Passion: Girls in Science

In Micki’s spare time, she is a huge advocate for women in science – especially girls that are just learning about science in the classroom at school. Micki belongs to an organization called “Women in Bio” (WIB), an organization to empower entrepreneurship of women in STEM (Science, Technology, Engineering, and Math), including career development and building each other up – no matter each individual’s level of seniority. Micki is Co-Chair of the Young Women In Bio (YWIB) where she spends much time volunteering in lower socioeconomic schools, science fairs, mentoring, outreach, and putting on discussions and STEM educational opportunities.