Molecular Dx: Invitae drops prices as NIH starts 1,000-patient, molecular abnormalities cancer study

Newly public genetic information company Invitae ($NVTA) has dropped prices for its genetic tests, just as the NIH says it will launch a study of the efficacy of cancer drugs by genetic mutation. Both are a testament to the rapidly evolving role of genetic information in patient treatment.

Invitae has reduced its patient price for each indication on its menu of genetic tests to $475 from $1,500. As for payers, those in contracts with the company pay $950 per indication, while out-of-network and noncontracted institutions will still pay $1,500 per indication.

The company had conducted more than 6,200 billable tests at March 31. Of these, about one-third were billed to institutions and patients, while the remaining two-thirds were billed to third-party payers. However, many of those billed to payers were denied, Invitae disclosed in its latest quarterly SEC filing.

Although payers in principle may reimburse for genetic tests that are billed, if they don't have an existing relationship with Invitae these companies may deny the claim, the company said. The new, lower patient price may encourage them to simply purchase the tests out-of-pocket, rather than wend their way through an arcane process of gaining payer approval for them.

"Most of the conversations about reimbursement for genetic testing have focused on economic issues. However, an under-appreciated dimension in using genetic testing for genetic care is an ethical one. For years, many people and their families have not had the benefit of clearly indicated genetic testing due to unwillingness of third-party payers to pay the historically high cost," said incoming Invitae CMO Dr. Robert Nussbaum, who is also the chief of the Division of Genomic Medicine at UCSF Health, in a statement.

He continued, "Now that the genetics market is becoming a generic market--and thanks to the ongoing innovations and cost reductions in sample preparation, sequencing and medical interpretation--we are beginning to see the benefits translated into affordable testing for patients."

When Invitae launched its commercial product in November 2013, it had an assay of 216 genes comprising 85 different genetic disorders and 17 targeted panels. At the end of the first quarter, it had increased that to 221 genes and it expects to expand to 500 genes during the second half of this year. Its tests address cancer, cardiology, neurology, pediatric genetics, hematology and other rare conditions.

Invitae CEO and co-founder Randy Scott

"The new patient pay program reflects our ability to bring affordable genetic testing to the masses in a medically responsible way," said Invitae CEO Randy Scott in a statement. "We believe we are well positioned to be one of the leaders in multiple markets, at multiple price points, serving a multibillion-dollar industry."

Invitae is also presenting data at the ongoing American Society of Clinical Oncology (ASCO) in Chicago in collaboration with two major medical centers on the clinical utility of expanded gene testing for hereditary breast and ovarian cancers.

Meanwhile, researchers from the National Institutes of Health's (NIH) National Cancer Institute and the ECOG-ACRIN Cancer Research Group, which is part of the NCI-sponsored National Clinical Trials Network (NCTN), are planning a 1,000-person trial to study the use of cancer drugs targeted to gene abnormalities.

The research could help justify the increasingly common practice of prescribing based upon the genetic mutations of tumors--rather than the location within the body that the tumor is found.

Dubbed NCI-MATCH, the Phase II trial will include more than 20 different drug or drug combinations to target specific gene mutations. Each patient in the trial will be matched with a therapy based upon the molecular abnormalities in their tumors. The researchers will start screening an anticipated 3,000 patients for participation in the trial from the 2,400 NCTN sites in July.

Initially, it will contain about 10 substudies, which will increase to 20 substudies or more within months. Based upon DNA sequencing of tumor biopsies, patients will be matched to these groups. Patients will include adults with solid tumors or lymphomas who have advanced to at least one line of standard systematic therapy or have tumors for which there is no standard treatment. Each arm will have up to 35 patients, with at least one-quarter of the total patients to have rare types of cancer.

"NCI-MATCH is a unique, ground-breaking trial," said NCI acting director Dr. Doug Lowy in a statement. "It is the first study in oncology that incorporates all of the tenets of precision medicine. There are no other cancer clinical trials of this size and scope that truly bring the promise of targeted treatment to patients whose cancers have specific genetic abnormalities. It holds the potential to transform cancer care."

- here are the Invitae and NIH releases

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