Roche's Ventana inches closer to FDA approval for lung cancer companion Dx

Positive case of lung tissue stained for ALK with Ventana's Ventana ALK (D5F3) companion diagnostic test--Courtesy of Ventana Medical Systems

Roche's ($RHHBY) Ventana Medical Systems has submitted its companion diagnostic test for ALK1-positive lung cancer for FDA approval, inching the company closer to full regulatory approval for the product and helping it gain ground in a fiercely competitive cancer diagnostics market.

The company's Ventana ALK (D5F3) immunohistochemistry (IHC) test pinpoints changes in the ALK gene that produce an abnormal protein that causes cells to grow and spread. The product helps identify which patients would benefit from a treatment that inhibits the ALK gene, providing a more efficient and cost-effective method for scanning for the disease. Ventana's submission of the test marks the fourth and final step required by the FDA for full premarket approval (PMA) of the product.

"Premarket approval of the Ventana ALK (D5F3) CDx Assay will enable more lung cancer patients to access ALK gene testing and obtain faster test results over current FISH or molecular testing methods," Doug Ward, Ventana's Lifecycle Leader for Companion Diagnostics, said in a statement. "We are very pleased about the potential impact of this important diagnostic in providing these patients access to drugs specifically designed to target the ALK mutation."

Ventana counts companion diagnostics as its bread and butter business, and a new approval for its lung cancer test would bode well for the company as its broadens its market share. The Tucson, AZ-based company has worked with more than 45 biopharmaceutical partners since 2002 and has more than 180 collaborative projects underway to develop companion diagnostics globally, Ventana noted in its statement. In March, the company expanded its collaboration with pharma giant Bayer to develop immunohistochemistry-related tests to go along with the drugmaker's biomarker-targeted treatments. In July, Ventana announced that it would develop a companion diagnostic test with Germany's Merck KGaA that can be used for different types of cancer.

Meanwhile, other companies continue to chart progress with diagnostic products for lung cancer. Earlier this year, molecular diagnostic outfit Biodesix reeled in $12 million in Series E financing to ramp up development for its blood-based test for non-small cell lung cancer. The product helps oncologists decide whether to treat lung cancer patients with Roche's Tarceva or traditional chemotherapy. The same week, San Diego-based oncology diagnostics company Biocept ($BIOC) said it would team up with Insight Genetics of Nashville to develop a test that can identify and monitor patients who may benefit from ALK-based therapies.

- read the release

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.