Dive Brief:

• Exact Sciences' $2.8 billion deal to integrate Genomic Health is complete, the company announced Friday. 
• Separately, Exact Sciences said it received breakthrough device designation from FDA for a test that assesses six blood-based biomarkers for hepatocellular carcinoma (HCC), the most common form of primary liver cancer. Results from a 443-patient study of the test will be presented this weekend at the American Association for the Study of Liver Diseases annual meeting. 
• The Madison, Wisconsin-headquartered Cologuard maker plans to roll out the HCC test by the second half of 2020. "This will help generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption of the test over time," the company said.

Dive Insight:

With Genomic Health officially folded in, Exact Sciences gains the Oncotype DX line of tests currently marketed to assess a breast cancer patient's likely response to certain treatment options.

Upon the deal's announcement in July, Exact Sciences pegged the 2020 outlook for the combined company at $1.6 billion in total revenue and $1.2 billion in gross profit. It anticipates $25 million in annual cost savings by the third year after close.

Exact shed light on the company's structure with Genomic Health in a filing to the Securities and Exchange Commission Oct. 28, disclosing that numerous Genomic Health executives, including CEO Kim Popovits, would not be a part of the combined company.

Among the members of Genomic's team continuing with Exact are CFO Brad Cole, who will serve as general manager of Oncotype DX, and co-founder and Chief Scientific Officer Steve Shak, who was named chief medical officer. Genomic's chief U.S. commercial officer Jim Vaughn was slated to become Exact's U.S. commercial lead for the Oncotype DX brand.

The next level of leadership is set to be announced in early November, according to the filing.

"We intend to transition to a business unit model with four units focused on the Cologuard business, the Oncotype DX business, international business, and the combined pipeline opportunities for both organizations," CEO Kevin Conroy also said in the filing, adding the shift to the new business unit model is expected to take between three and six months following close.

Genomic Health's stock will no longer be traded on the Nasdaq. It closed at $63.44 per share Thursday.

Beyond the Cologuard and now the Oncotype DX brands, Exact Sciences continues to press forward on its liquid biopsy development projects. Exact Sciences is partnered with the Mayo Clinic on a long-term goal of identifying biomarkers for the 15 deadliest cancers.

On the liver cancer front, Exact Sciences noted ultrasound or a blood test for alpha-fetoprotein (AFP) are currently recommended every six months for at-risk individuals. Citing a meta-analysis published in the journal Gastroenterology last year, Exact said the ultrasound and the AFP tests have a combined sensitivity of 63% for detecting early-stage cancers. 

"Three-year survival rates nearly double for patients who undergo regular testing compared to those who do not, yet fewer than one-third of patients adhere to current guidelines," Exact Sciences said in its announcement Friday.

Exact said it generated results in a study of 443 patient blood samples showing that at a specificity of 90%, its four methylated DNA markers and two protein markers caught 80% of HCC cases across all stages of the disease. Among early-stage cases, the Exact test was sensitive to 71% cases, compared to AFP's 45%.

But Exact Sciences faces competition as it works to move the test to market. FDA awarded a breakthrough designation to Laboratory for Advanced Medicine (LAM) in September for an HCC liquid biopsy that, like Exact's test, uses methylation markers. A LAM study based on 154 patients found the test detected liver cancer with a sensitivity of 95% and a specificity of 97.5%. The company planned to conduct a 1,600-subject study comparing the sensitivity and specificity of its test to ultrasound.