Invitae gears up for next chapter with genome management aspirations

It's said that timing is everything, and for Invitae ($NVTA), the old adage rings true. The company has grown by leaps and bounds since entering the market in 2013, after a U.S. Supreme Court ruling found that patents for human DNA were invalid. With testing volumes on the rise and revenues growing steadily, the company is set to enter its second phase of business, CEO Randy Scott told FierceDiagnostics.

Invitae already boasts an assay of 216 genes covering 85 genetic disorders and 17 panels focused on hereditary cancers including breast, ovarian and colon. And the company is not stopping there, moving past the 500-gene mark in its genetic testing menu during its second quarter and shooting to add another 500 genes in 2016. Ultimately, Invitae is aiming for a test menu of more than 1,000 genes with tests for all genetic inherited disorders priced at less than $1,000, Scott said.

But once the company checks that goal off its list, it will focus on genome management, Scott said. As personalized medicine becomes more commonplace, there is a demand for products that allow patients and providers to access genetic information. By using Invitae's genome management system, healthcare professionals could see if a cancer patient has bleeding or blood clot disorders or other risks that would impact their care, Scott said.

"As we go through our life, we have to manage different conditions and disorders, and we take different drugs," Scott said. "So housing that on behalf of a patient and being able to inform them in real time we think is going to have value in and of itself."

Meanwhile, the company is delivering on its promise of driving down costs to make testing more affordable. In June, Invitae announced that it would slash prices for its genetic tests, planning to offer its products at a patient price of $475 rather than $1,500. Payers who have contracts with the company will pay $950 for the tests, providing a more cost-effective alternative. And as genetic sequencing costs continue to drop, the company's model could gain even more traction.

Invitae CEO and co-founder Randy Scott

"I've been involved in this field since the '90s. You could identify the Moore's law effect in DNA sequencing even then," Scott said. "We made the price change because we believe as we grow volume significantly, we'll be able to grow gross margins based on the prices we put out. The more we drive down prices, the more market share we can gain."

Invitae is also working on reimbursement for its tests, talking to medical directors and various payers to move the company toward contracting, Scott said. Faced with fewer legal and technological barriers, Invitae could be on its way to grabbing a bigger piece of the testing market.

"From a legal standpoint, the Supreme Court decision to throw out patents on human genes removed a major hurdle," Scott said. "Now, it's just a matter of driving and demonstrating the clinical utility, getting in to the payer system and working through the regulatory components. That all can take some time, but we think the barriers have all been largely removed." -- Emily Wasserman (email | Twitter)