A DiaTech lab staff member verifies a patient's cancer cells after preparing the sample for testing.

The Science Behind DiaTech

Founded by clinical lab veteran Garry Latimer, DiaTech Oncology is the first to offer patient-specific cancer testing by measuring drug-induced apoptosis — the death of cancer cells caused by chemotherapeutic drugs — prior to drug administration.

Unlike commonly used cell growth-based assays, which measure the number of tumor cells that survive chemotherapy, DiaTech’s Microculture Kinetic (MiCK) assay for apoptosis is a death-based assay that uses a unique algorithm to monitor and compute the amount of cell death caused by each drug. A drug sensitivity profile is sent to the patient’s oncologist who then selects the best therapy based on the individual patient's results.

"Vanderbilt researchers had proven the technology worked in leukemia patients and thought it would work in all solid tumors," Latimer said. "We recently finished our clinical study, which showed it did work very well in these types of cancers."

In fact, patients who received DiaTech’s MiCK assay for apoptosis saw more than 80 percent predictive value of complete response and survival.

The Results Are In

Latimer and his research team now are finalizing three major study manuscripts for publication and anticipate commercialization of the MiCK assay by 2012. Commercial testing already has been conducted in more than 900 patients from oncology groups in Nashville, California, Florida, Texas and New York. In 2011, DiaTech also announced engagement in a pilot program with Walter Reed Army Medical Center in Washington, D.C. The study will be introduced to other military hospitals and results will be collected on multiple cancers.  

Karl Rogers, MD, of Nashville Oncology Associates and Baptist Hospital, has worked closely with Latimer’s team, frequently utilizing MiCK assay in his own practice.

“Patients are asking why this hasn’t been the standard of care, but the technology just wasn’t available until now,” Rogers said. “For decades we’ve been treating patients through trial and error because, unfortunately, we can’t pinpoint each patient’s individual biology based on past patients. We’ve been talking a lot about giving patients personalized cancer care, and instead of treating it by tissue of origin, we can now tell what each tumor is specifically sensitive to.”

The MiCK assay process begins by testing a patient's cancer cells against three to four chemotherapeutic drugs and continues testing all relevant protocols, including single and combination therapies, until the most effective treatment is found. Currently there are nearly 50 chemotherapy drugs on the U.S. market, each with an estimated success rate of 15 to 20 percent.

“We have a lot of good drug therapies out there,” Rogers said. “The key is to refining that. We can pick the best drugs that will be helpful; and if we have several quality, effective drugs, we want to pick the least toxic.”

Impact on the Industry

According to Latimer, the availability of MiCK assay means pharmaceutical companies can concentrate development resources on drugs that are most active against tumor cells and can also identify which patients might respond best to the experimental chemotherapy agents in clinical trials. Cancer cells exposed to a new, experimental chemotherapy drug can be monitored for as long as 96 hours for apoptosis. In the field of drug discovery, the MiCK assay can reduce costs associated with validation studies and the time required to obtain FDA approval for marketing.

The technology also brings a notable change to the treatment process for cancer patients and their physicians.

"Typically, a patient gets diagnosed with cancer, is sent to a surgeon who removes it, and then is sent to oncology," Latimer said. "We enter the picture before the patient sees an oncologist so the patient has a test result to take to oncology."

Unlike chemoresistance assays, which can take weeks for results, MiCK assay results typically are available within 72 hours.

"This test has the opportunity to be used by all oncologists as a tool to get patients the best chemotherapy," Latimer said. "Most of our patients have been through chemo, and it's failed. We‘ve tested their cancers and proven the drugs they were on didn’t work."

Going Commercial

Making the test widely available is the next step for DiaTech Oncology. Latimer is in talks with payers and has received approval from United Healthcare to cover testing in all breast, colon and lung cancer patients. Following publication, MiCK assay is expected to receive complete approval from private payers and Medicare. The test costs $3,600 and is expected to save payers between 20 to 80 percent of chemotherapy costs. DiaTech also is creating a Patient Assistance Program to provide the MiCK assay for individuals who might otherwise lack financial means.

The privately held company recently assembled a medical advisory board comprised of prominent oncologists from the Mayo Clinic in Minnesota, The University of Texas’ M.D. Anderson Cancer Center, and Memorial Sloan-Kettering Cancer Center in New York City. DiaTech Oncology has been granted exclusive licensing rights to MiCK assay technology from Vanderbilt University.

“It takes a while to introduce it all, but things are coming into place very nicely,” Latimer said.

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