ViewPoints Interview: PGDx’s Megan Bailey Shares Insight on the Partnership with QIAGEN and Almac

In an interview with PharmaShots, Megan Bailey, CEO of PGDx shared her views on PGDx’s collaboration with QIAGEN and Almac to advance cancer diagnostics and make precision medicine more accessible to healthcare systems, laboratories, and patients globally.

Shots:

• On Jan 11, 2021, PGDx and Almac collaborated to enhance patient care in the oncology
• On Jan 13, 2021, PGDx collaborated with QIAGEN to provide comprehensive genomic profiling tests and clinical decision support to molecular labs
• The PGDx elio tissue complete is the first FDA-cleared standardized test for all solid tumors that any lab across the country can perform

Tuba:  Put some light on your collaboration with QIAGEN and Almac.

Megan: All of our commercial efforts, including partnerships and other collaborations, are designed to advance cancer diagnostics and make precision medicine more accessible to healthcare systems, laboratories, and patients worldwide.  Our mission is to Empower the Fight Against Cancer; we aim to give everyone with cancer the best shot at beating the disease, regardless of where they live or where they seek treatment. 

QIAGEN:

Collaboration to Offer Integrated Genomic Testing and Interpretation Support

We are partnering with QIAGEN to accelerate the adoption of next-generation sequencing (NGS) as a clinical decision-making tool.  To do so, we are pairing our comprehensive pan-cancer tumor profiling assays with QIAGEN’s clinical informatics platform to reduce time to results and simplify clinical genomic analyses.

Under the non-exclusive agreement, PGDx will be responsible for the distribution of the PGDx elio oncology products and kitted solutions to molecular labs. Laboratories that purchase the PGDx elio products will have an option to receive from QIAGEN standardized reporting, driven by professional guidelines for streamlined case review and sign-out. In addition, laboratories will receive access to QIAGEN’s QCI Interpret One for rapid, evidence-based reporting for next-generation sequencing oncology tests at scale.

Cancer guidelines increasingly call for comprehensive molecular profiling to optimize treatment planning and inform care. PGDx elio tissue complete, the first FDA-cleared comprehensive genomic profiling kit, is used to identify alterations in the tumor and inform treatment decisions for patients with advanced solid tumors. The kitted PGDx system allows molecular laboratories anywhere to perform this advanced genomic testing of cancer in a more efficient, standardized, and accurate manner.

Almac:

Collaboration to Enhance Patient Care and Speed the Development of New Oncology Medicines and Companion Diagnostics

PGDx and Almac Diagnostic Services will focus on providing access to tumor profiling assays for both tissue and plasma samples, specifically, PGDx elio tissue complete and PGDx elio plasma resolve. This collaboration will combine Almac’s world-class genomics services to the biotech and pharma industries with PGDx’s leading cancer genomics platform to accelerate solutions that will deliver precision medicine to more patients. 

Tuba:  Discuss the specifications of PGDx elio platform and also give its advantages.

Megan: PGDx has developed a portfolio of standardized tissue-based and liquid biopsy next-generation sequencing assays for laboratories worldwide, featuring automated bioinformatics that ensure consistent results and quality of testing. By automating the data analysis process, PGDx is enabling the scalability of precision medicine with a fast, reliable, and accurate system.

Our portfolio of NGS assays works in all solid tumors to identify clinically actionable and guideline-supported biomarkers to inform treatment decisions for patients with advanced cancer. With an in-house testing option, PGDx is empowering healthcare professionals to more rapidly identify patients’ unique biomarkers and inform care pathways that optimize treatment options for patients.

Advantages:

• Ability to utilize local laboratory and pathologist expertise
• Avoid send out testing
• Maintain ownership of valuable samples, data, and patient results
• Deliver actionable results in as little as 4-5 days
• Manage testing schedule and lab priorities
• Faster turnaround time to reliable results, enabling the best and most informed treatment decisions

PGDx elio tissue complete

• 500+ Full Coding Genes for Sequence Mutations
• Complex Alterations including Indels, Amplifications, and Translocations
• TMB and MSI
• CE Marked
• FDA Cleared

The PGDx elio tissue complete is the first FDA-cleared standardized test for all solid tumors that any lab across the country can perform. These diagnostic results quickly give physicians and patients a volume of important information, extending the promise of precision medicine to many more patients.

Up until now, there was one way to get a test like this, and that was sending samples to one centralized location. Results would take 3-4 weeks and for people living with cancer, every minute waiting for answers feels like 100 years.

The FDA has approved our test as a packaged, validated solution scalable to medical centers and labs across the country to deliver fast, consistent and reliable results to patients in 4-5 days.

PGDx elio plasma resolve*

• 30+ Full Coding Genes for Sequence Mutations
• Complex Alterations including Indels, Amplifications, and Translocations
• MSI
• CE Marked

*For U.S. Customers: Research Use Only

Tuba:  How does the collaboration with QIAGEN help you to bring more comprehensive solutions for clinicians and patients?

Megan: By pairing tests and interpretation support that can be run locally and automating the data analysis process, PGDx and QIAGEN are enabling the adoption of precision medicine in healthcare systems across the country, no matter where a patient seeks treatment.  It is important for our customers to be able to stay up to date with clinical guidelines and evidence supporting variant interpretation to maximize the value of NGS data in improving clinical care. It also allows clinicians a pathway to maintain control over the patient relationship, to conserve valuable tissue samples and to participate in the economic chain that today is slanted toward centralized labs outside of the communities where patients live and are treated.

Tuba:  How will the addition of QIAGEN’s clinical decision support software advance cancer diagnostics and make precision medicine more accessible to healthcare systems?

Megan: QCI Interpret One enables clinical labs to deliver oncologist-ready variant interpretation reports from NGS tests faster and with greater precision than ever before. Paired with the kitted PGDx system, it allows molecular laboratories anywhere to perform advanced genomic testing of cancer in a more efficient, timely, standardized, and accurate manner.

Tuba:  Why would you choose Almac to enhance patient care in oncology?

Megan: Their longstanding reputation for providing high quality lab services to biopharma and other healthcare partners worldwide, along with their proven track record of implementing new technologies, make this partnership ideal.  As we continue our quest to empower the fight against cancer, collaborating with Almac will allow us to deliver precision medicine solutions to a broader population via their work with the new therapy and companion diagnostic pipelines.

Tuba:  How do Almac’s genomics services help PGDx to deliver precision medicine to more patients?

Megan: This collaboration will combine Almac’s world-class genomics services and reach into the molecular diagnostics and therapeutics development segment with PGDx’s leadership in kitted cancer genomics to accelerate solutions that will deliver precision medicine to more patients.  The more these research operations can use a more efficient, personalized and purpose built kitted assay solution, the more success programs will have, leading to a greater hit rate for new medicines and companion diagnostics.

Tuba:  Are you looking for more collaborations to create CDx products for personalized medicines of the future?

Megan: All the time.  We are always engaged with new partners and collaborations, especially since our FDA clearance and successful pilot programs have become better understood across the oncology ecosystem.

Tuba:  How do you think genome sequencing and liquid biopsy technologies can empower the fight against cancer? 

Megan: Cancer is a disease of the genome. In order to understand it and fight it, we need to know where the weaknesses are genetically.  Precision medicine is not precision medicine without standardized genomic testing that determines the best plan of attack and can open the door to targeted treatments and clinical trials.

We know that most cancer patients are diagnosed with a tissue biopsy. Tissue remains the gold standard, but liquid biopsies, or blood samples, are a great option for patients who aren’t able to have tissue biopsies done for various reasons. But a lack of tissue sample shouldn’t negate cancer patients from potentially lifesaving, personalized treatments – and that’s why they’re so important.

PGDx elio tissue complete is the first FDA-cleared standardized test for all solid tumors that any lab across the country can perform. These diagnostic results quickly give physicians and patients a volume of important information, extending the promise of precision medicine to many more patients.  We know that information is power when it comes to fighting cancer.

Image Source: Moffitt Cancer Center

About Author:

Megan joined PGDx in March 2018 as the Vice President of Marketing and was promoted to Chief Commercial Officer where she led the Company’s marketing, sales, customer support, and communications in developing and executing global go-to-market strategies.

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