Microbiologics offers ready-to-use quality control microorganisms for use in clinical labs of all formats and sizes

Aug. 18, 2014

 

Brad Goskowicz

CEO, Microbiologics

Professional

I have been CEO of Microbiologics for about six years now. Prior to joining Microbiologics, I was the VP of Clinical Development for Myocor. Much of my past professional experience has been in the medical device marketplace, primarily cardiology and cardiac surgery.

Education

B.S. in Medical Technology and Chemistry, Marquette University. 2011 Alumnus of the Year award from the College of Health Sciences

Personal

“I currently serve on the Board of Directors of the American Organization of Analytical Chemists and the American Association of Laboratory Accreditation. Speedskating has been a passion of mine since I was young. In my early years I competed in more than 150 U.S. speedskating competitions, setting national records and winning titles. I served on the Board of Directors of US Speedskating for more than 20 years, five as the organization’s president. In 2009 I was inducted into the U.S. Speedskating Hall of Fame as a contributor to the sport. ”

If you were explaining Microbiologics to someone who was not familiar with the organization, how would you characterize its primary areas of expertise? Our expertise is in producing practical, user-friendly, quality control biomaterials for clinical, pharmaceutical, cosmetic, food, and water testing laboratories. We currently sell to hospitals, clinics, and labs in more than 130 countries. We take specific strains of bacteria, yeast, fungi, parasites, viruses, and other pathogenic biomaterials that we source from selected repositories, and we develop them into stable, easy-to-use formats. 

Having accurate standards and controls is the foundation of any testing program. Our controls are mostly viable organisms, which makes them very challenging to work with, stabilize, and ship safely. Hospitals need our controls to make certain their growth media work, their instruments are providing accurate identification, and that antibiotic sensitivity is reflected accurately. Rapid diagnosis and effective therapy is critical in healthcare today.  

What are the major categories of solutions that Microbiologics provides for its customers? Categories of Microbiologics’ solutions include qualitative and quantitative lyophilized QC microorganisms, Certified Reference Materials, synthetic DNA/RNA molecular controls, parasite suspensions, and microbiology QC slides. Customers derive many benefits from using our QC microorganism solutions. Microbiologics products can significantly reduce time with their ease of use, compared to manual methods of preparing and storing controls in-house. In addition, there is no concern about contamination or mutation of these very adaptive organisms. Each product comes with a Certificate of Analysis, and of course the use of third-party controls in the laboratory is well established.  We also prepare and provide microbiology proficiency samples to various clinical proficiency providers in the United States. 

How does Microbiologics support microbiology quality control programs? What are some important innovations in the production of reliable QC microorganism preparations for microbiological Quality Control testing? Microbiologics provides reference materials which are used to ensure that a laboratory’s systems, equipment, materials, processes, and personnel are all consistently producing accurate test results. Quality control is not something to be taken lightly because so much rides on the accuracy of the laboratory’s test results. Laboratories must be 100% certain that every component of their testing is functioning properly. That’s where our QC microorganisms come in. Without proper controls in place, how can you be sure your tests are working?

How have Microbiologics’ solutions evolved in recent years to address changing customer needs? The healthcare industry continues to receive mounting pressure to mitigate costs. As a result, we are seeing many laboratories adopt more automated technologies in diagnostics. These rapid diagnostic instruments and test kits continue to evolve and become more sophisticated, offering unprecedented speed and accuracy. Traditional culture methods are being superseded by automated modalities. The future of clinical microbiology will most definitely involve molecular diagnostic technologies, such as mass spectrometry and amplification systems.

At Microbiologics, we have an ongoing initiative dedicated to research and development. We recently launched a new Molecular Products and Services division. We are expanding our range of biomaterials to include viruses and other hard-to-grow microorganisms with synthetic DNA/RNA products, as well as genomic extracts and other molecular controls. 

Microbiologics is currently expanding its activity in the clinical field. What products and services are you stressing in this expansion? With our new molecular division in place, we are partnering with rapid technology manufacturers to support the development of molecular diagnostics. We are working with them to provide custom-designed internal or external controls for the development, validation, and monitoring of their technologies. One example is our new Helix Elite Molecular Standards, which includes a series of synthetic RNA and DNA sequences to be used as amplification controls in clinical assays.

How do your product lines address the needs of labs of different sizes and areas of specialization? We pride ourselves on having the largest and most diverse line of QC microorganisms and standards in the world. Our product catalog is comprised of more than 800 microorganism strains which we manufacture into 21 unique product formats. Smaller laboratories are more likely to be using traditional microbiology methods where our lyophilized microorganisms would be used for quality control. Larger laboratories may be utilizing automated technologies where our molecular controls would be needed. Some labs may use a combination of both culture-based methods and molecular assays. Microbiologics can serve any format or volume of biological controls our customers need.

The company is FDA registered, conforms to CE Mark regulations, has achieved ISO 13485 Certification, and is accredited to ISO 17025 and ISO Guide 34. Why is this kind of credentialing important to customers of Microbiologics? Microbiologics has an intensely robust Quality System in place; it’s something that we are very proud of, as it is no small feat. We are audited almost weekly by customers and regulators alike. Our credentials are a testament to Microbiologics’ ability to consistently design, develop, produce, and distribute biological controls and standards of the highest quality. Customers know that our products undergo rigorous internal quality checks and analyses before they arrive at their laboratory.  

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