By Lori Sichtermann

 Mark Myslinski

The concept of a family tree works well when describing the development, purpose, and success of Veridex LLC. With its lineage extending back to one of the most innovative research and development companies in the country, Veridex faces a market with large unmet needs where the application of new technology can have a dramatic impact.

Veridex LLC, a Johnson & Johnson company, provides physicians and patients with in vitro diagnostic oncology products. The company’s products benefit patients through early disease detection, and enable personalized medicine strategies to improve patient management and outcomes.

Clinical Lab Products recently spoke with Mark Myslinski, general manager of the Warren, NJ-based operation, about the new company, the direction it plans to take, and the role it currently satisfies in the growing oncology diagnostic market.

CLP: Please explain the relationship between Veridex and Johnson & Johnson?

Mark Myslinski: Veridex is an LLC, which means it’s an independent company. However, it is part of the Johnson & Johnson family of companies, which includes Ortho-Clinical Diagnostics, from which Veridex was spawned.

CLP: What is the story behind Veridex’s development? What need in the market does the company satisfy?

Myslinski: The idea behind the development of Veridex was that the company would attempt to identify and satisfy unmet needs in the field of oncology. Given the expertise of our parent company, Johnson & Johnson, in the field of oncology, the synergies between therapeutic discovery and diagnostics held tremendous promise. Acting on these ideas led to the development of Veridex.

The company came about by way of targeted therapeutics and the opportunity to develop theranostics and pharmacogenomic products that would result from using molecular technology coupled with unmet needs. The company was built around two platform concepts based on their significant clinical value. The first platform resulted from synergies from the pharma group and the ability to apply discovery results to diagnostics. The second platform was developed by, and licensed from, one of our collaborators, Immunicon Corp, in cellular oncology diagnostics.

When we were considering these two platforms, we asked ourselves, “Could a company be built around the clinical value these two platforms provide?” And the answer, which was heavily studied, was yes. There were enough unmet needs in the market where these technologies could be applied to help solve issues in oncology diagnostics.

CLP: The company plans to play a key role in the growing trend of more personalized health care. How do you define “more personalized health care,” and how will Veridex participate in the growth of this concept?

Myslinski: We have three views of the term personalized health care or personalized medicine. Essentially, the concept entails directing therapy based upon a diagnostic outcome that is specific to a particular patient.

The first application is to monitor response to therapy; the CellSearch™ system is suited for this. In this case, a physician can use the results of the assay to assist in determining if the therapy is effective for that patient at that time based upon the patient’s circulating tumor cell count. For example, if a patient’s cell count is above the cutoff of 5 cells in 7 1/2 µL of blood, then it is likely that the patient is not responding to that therapy. The concept is not therapy-specific, but instead concentrated on a patient’s response to a particular therapy.

The second element of the concept of personalized medicine ideally comes from finding the right patient who will respond to a particular therapy based on his or her genetic makeup. Simply, physicians can use diagnostics to identify which patients are likely to respond to a particular therapy. It is believed that there are therapeutics that will work better in some patients, and those patients will be identified by targeted molecular diagnostics.

The third segment is using a gene set to assist clinicians in prognosis, or upstaging or downstaging patients based upon the genetic makeup of the tissue or sample.

CLP: What products has the company released to the market?

Myslinski: We recently released the CellSearch technology, which was approved by the FDA in January of 2004 in the “de novo” classification.

CellSearch is a new cancer diagnostic technology that identifies and counts circulating tumor cells in a blood sample to predict progression-free and overall survival in patients with metastatic breast cancer.

The system works by detecting cancer cells that detach from solid tumors and enter the bloodstream. The presence and number of these cancer cells in blood provides valuable information to physicians for evaluating the response to therapy in patients with metastatic breast cancer. It’s the first of its kind to automate the detection and enumeration of circulating tumor cells in peripheral blood.

The CellSearch technology is currently available at a major reference laboratory, and we are working with a number of cancer centers and hospital laboratories to offer this product in the fourth quarter.

CLP: Veridex has collaborated with such companies as Immunicon Corp and Johnson & Johnson Pharmaceutical Development LLC to develop some of the technologies in its product line; what have been the benefits of these collaborations? Does Veridex plan to continue working with these and other companies in the future?

Myslinski: Yes. We plan to continue working with a number of companies in the future. The current thought is that not everything has to be made or invented by Veridex here in Warren, NJ. To help us solve unmet needs in oncology, we are trying to find solutions whether developed here or outside of Veridex. If we can develop ideas internally, that’s great. If we have to work with partners from outside our company, then that’s fine as well.

An example of this concept is our relationship with Immunicon Corp. Today we have worldwide, exclusive marketing right to their products in the field of oncology. Additionally, we have a relationship with a company called Cepheid that provides the PCR platform for several of our nucleic acid-based assays.

Our work with Johnson & Johnson Pharmaceutical Development LLC results from a desire to develop synergies among Johnson & Johnson companies. The leadership of Veridex saw a market for applying drug development technologies to the diagnostic field.

CLP: What products does Veridex plan to introduce to the market in the future?

Myslinski: There are a number of products we plan to bring to the marketplace in the near future.

We plan to release an intraoperative assay for the assessment of breast tissue in lymph nodes. This will be the first gene-based test for guiding surgery intraoperatively. The assay will enable surgeons to decide whether to do an axillary lymph node dissection at the time of a lumpectomy; or if the nodes are negative, close and avoid an unnecessary axillary dissection. This product is going through registration trials right now, but we expect to release it to the market in mid 2005.

Additionally, we have a colon prognostic product that will be used to stratify Dukes B patients into those who are at high or low risk of reoccurrence based on a gene signature from their primary tumor. This will allow surgeons to upstage the patient if shown to be at high risk of reoccurrence.

CLP: With only one product out, how will Veridex market its products?

Myslinski: Marketing in the field of oncology, particularly with new technologies, is a bit complicated. This is not your traditional diagnostic where it replaces an existing assay. We have to create both the demand for and the supply of the product.

We have our own sales force that will work with laboratories and clinicians to provide the supply of the offerings, and we will use an additional sales force to create the clinical demand.

CLP: Any final thoughts?

Myslinski: Veridex is focused on meeting the unmet needs in the field of oncology diagnostics. Our focus is on trying to help patients in the fight against cancer. What gets us up in the morning is the drive to produce tools that will provide better answers for clinicians and patients.

Lori Sichtermann is associate editor of Clinical Lab Products.