What Should IVD Manufacturers Look for When Selecting a Lab Testing Partner?

In vitro diagnostics, or IVD, is a field where precision, reliability and robust partnerships propel advancement. Each diagnostic evaluation and every lab discovery signify not only technological advancement but also the fruit of integrated teamwork, with decisions made collaboratively. This is where collaboration meets innovation, and an effective strategic partnership can truly spark achievement. Selecting the right lab testing collaborator can be as pivotal as the innovation itself.

The collaboration between IVD manufacturers and lab testing partners is central to precise and efficient diagnostic processes. So, what considerations should IVD manufacturers bear in mind when determining this crucial partnership?

To delve deeper into this subject, Xtalks spoke with Dr. Neelam Dhiman, Director of Science, Molecular Infectious Diseases at Quest Diagnostics. Dr. Dhiman unraveled the complexities of the IVD field, highlighting the importance of collaboration between IVD manufacturers and lab testing partners.

“When IVD manufacturers develop a new assay on their instrument, they need to perform reproducibility studies, typically with a minimum of two external lab partners in order to demonstrate the robustness and reliability of the test, and to demonstrate that the test can be reliably performed by other laboratories using the same or similar equipment and methods,” explains Dr. Dhiman.

Dr. Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines and infectious disease diagnostics. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota.

Dr. Dhiman is a scientific expert in molecular infectious disease and women’s health and is actively engaged in multiple clinical trials with a special interest in rapid molecular diagnostics for sepsis.

Partnering for Precision: The Power of Collaboration

In today’s rapidly evolving medical landscape, the need for reliable and efficient IVD testing has never been more crucial — and Quest Diagnostics has a monumental role in the IVD industry. With an impressive track record of hosting 140 million unique patient events annually and a vast portfolio of 3,500 assays, Quest positions itself as a leading partner for IVD manufacturers. The ability to deliver samples, space, devices, staffing and a robust infrastructure sets Quest apart.

But why should IVD manufacturers choose Quest Diagnostics as one of these partners? Dr. Dhiman cites five primary reasons:

• Sample availability for studies
• Space provision for instruments
• Availability of predicate devices
• Adequate staffing for assays
• Established infrastructure for high-quality, efficient trials

With a staggering 500 million tests annually and a team of 650 MDs and PhDs available for consultation, it’s no surprise that Quest Diagnostics stands out as a reliable partner for IVD manufacturers and for supporting IVD clinical trials.

The Vital Role of Reproducibility Studies in IVD

Reproducibility studies are vital for the IVD submission process, establishing the accuracy and reliability of diagnostic tools. Their significance in the field of IVD is paramount. However, undertaking these studies can be daunting due to the immense volume of data and specimens required. Some studies might involve the collection and analysis of thousands of specimens.

“Having partnered with industry giants like Roche, Hologic, Illumina, BD, BioMérieux, Abbott, Luminex and more, Quest Diagnostics has been at the forefront of IVD advancements.”

 

— Dr. Dhiman

Quest Diagnostics emerges as an indispensable ally in this challenge. Their vast infrastructure is well-equipped to handle the magnitude of IVD reproducibility studies.

Beyond infrastructure, the value of the clinical team determines the success of a clinical trial. Quest Diagnostics has a large team of MDs and PhDs in different clinical areas of expertise who have the qualifications to serve as the Principal Investigator (PI).

However, a seasoned team alone isn’t sufficient. The diversity and breadth of samples available are equally critical. Quest boasts a rich biorepository of samples and can facilitate remnant sample enrollment of clinical sample prospective enrollment if needed for these trials.

Quest Diagnostics has a multidisciplinary approach with expertise across a multitude of disciplines such as infectious diseases, both conventional and molecular genetics, oncology, flow cytometry, hematology and many more. This extensive range ensures the accruement of a diverse set of samples, meeting the various needs of sponsors.

Additionally, sponsors partnering with Quest Diagnostics gain access to a plethora of instruments essential for their trials. As Dr. Dhiman pointed out, they often possess multiple devices on hand, enhancing the flexibility and capability of trials. And depending on project requirements, Quest can deploy a plethora of testing methods, from nucleic acid amplification to next-generation sequencing (NGS), catering to the diverse needs of their partners.

At the heart of Quest Diagnostics is an unwavering commitment to quality. “We are a CLIA, CAP, ISO-certified lab. Our robust quality management system is pivotal for US Food and Drug Administration (FDA) submissions,” explained Dr. Dhiman.

This adherence to top-tier standards ensures that every clinical trial they oversee is of impeccable quality. With an unwavering commitment to quality standards, the company boasts solid foundational practices ranging from good documentation practices to rigorous institutional review board (IRB) oversight.

Fostering Collaboration

The effectiveness of a lab partner becomes particularly pronounced when navigating the complexities of multi-site studies that demand patient reporting for the standard of care. Quest, with its experience, has fine-tuned its collaboration methods to address the challenges posed by diverse geographical enrollment sites, state licensure demands and intricate patient result reporting.

“With a dedicated team and facility, we focus on aligning our services with the unique needs of each client.”

 

— Dr. Dhiman

Dr. Dhiman highlights how Quest’s unique approach was evident in a women’s health study where collaboration between molecular cytology and histology laboratories was essential for patient reporting. By using a wider network of pathologists through their AmeriPath partners, specimens remained within one primary facility, preventing the need for external transfers.

Moreover, Dr. Dhiman also shared the example of an oncology study where a combination of molecular flow cytometry and cytogenetics testing was required. Dr. Dhiman explained how Quest’s methodical approach stood out, as the company “offered comprehensive studies under the same CLIA lab, which makes it really efficient for our sponsor to conduct their studies.”

Quest’s commitment to facilitating collaboration and catering to intricate research needs has made it a reliable choice for many professionals in the sector.

The Steps to Partnering with Quest Diagnostics for IVD Trials

Keeping simplicity at its core, Quest follows a straightforward three-step approach for potential partnerships. Starting with pre-contracting steps, it quickly moves to feasibility and site qualification. Once the contract is sealed, a comprehensive study plan is developed, ensuring smooth execution from kickoff to closeout.

Flexibility, according to Dr. Dhiman, is Quest’s strength. They pivot when needed, ensuring projects stay on track. Dr. Dhiman succinctly encapsulated their motto, “Deliver on time, on budget and on scope.” Given the complex landscape of IVD, such a commitment speaks volumes about Quest’s dedication to excellence and collaborative success.

By emphasizing streamlined procedures, adaptability and adherence to best practices, Quest embodies the spirit of innovation and collaboration that is pivotal to IVD.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.