Oncocyte, Bio-Rad Partner to Globally Launch Transplant Test

Original from: genomeweb

Oncocyte announced on Thursday that it has partnered with Bio-Rad Laboratories to globally commercialize the research-use-only GraftAssure assay.  

Separately, Oncocyte also reported Q4 revenues grew 15 percent year over year. 

Under the agreement with Bio-Rad, the two firms will co-market GraftAssure in the US and Germany, with Oncocyte acting as commercial lead, the Irvine, California-based company said in a statement. For all other countries, Bio-Rad has been granted exclusive global distribution and commercial rights.  

The test is expected to launch in Q2 2024 to select academic transplant centers in the US and EU and more broadly in the second half of 2024, Oncocyte noted. 

GraftAssure uses droplet digital PCR to quantify donor-derived cell-free DNA to detect signs of graft damage. 

"As we move towards launch, having the support of the Bio-Rad team in the US and Germany gives us the scale we need to meet the market opportunity," Oncocyte CEO Josh Riggs said in a statement. "The QX600 ddPCR platform, along with their expertise in serving the life science market, makes Bio-Rad a natural partner for our transplant technology." 

Bio-Rad expects to make an equity investment in support of the deal. Bio-Rad has also been granted an option for IVD commercial rights upon FDA clearance, subject to meeting specific objectives. Exercising that option would come with a second equity investment into Oncocyte. 

The collaboration "advances Bio-Rad's strategy to establish droplet digital PCR as a foundational technology by providing researchers and laboratories with high-value assays across a variety of life science applications," Simon May, Bio-Rad's EVP and president of life sciences, said in a separate statement.  

In a separate announcement on Thursday, Oncocyte said that it has entered into definitive securities purchase agreements for the purchase and sale of an aggregate of 5,077,387 shares of common stock at a purchase price of $ 2.9164 per share of common stock, and pre-funded warrants to purchase 342,888 shares of common stock at a purchase price of $2.9163 per pre-funded warrant.  

The gross proceeds are expected to be about $15.8 million. Oncocyte intends to use the funds to redeem outstanding shares of its series A preferred stock and for working capital and general corporate purposes. 

The private placement is expected to close on or about April 15. 

The firm also on Friday announced its Q4 and full-year 2023 financial results, reporting a Q4 revenue increase of 15 percent to $314,000. Revenues for the full year were $1.5 million, up 57 percent year over year. The increase was driven by increased revenue from its pharma services business, Oncocyte said in a statement.  

Net loss for the year was $27.8 million, or $3.75 per share, compared to a net loss of $72.9 million, or $13.25 per share, in 2022. 

The firm ended the year with $9.4 million in cash and cash equivalents. 

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Source: Oncocyte, Bio-Rad Partner to Globally Launch Transplant Test