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In Brief This Week: Grail, Renalytix, Novacyt, ClearNote Health, Singulab

NEW YORK –  Grail and Point32Health this week announced they have expanded a previously announced pilot to offer Grail's Galleri multi-cancer early detection screening test. The initial pilot program, announced in February 2022, enabled access to Galleri at no cost for eligible Point32Health employees and Harvard Pilgrim Health Care members who purchase their insurance on the Maine health insurance marketplace. The expansion of the pilot will now enable access for Point32Health's Commercial Tufts Health Plan or Harvard Pilgrim Health Care members who meet eligibility requirements for the test and whose primary care provider is a Mass General Brigham-affiliated provider. Point32Health is the parent company of Harvard Pilgrim Health Care and Tufts Health Plan. 

Renalytix reported this week that its full-year revenues rose 13 percent year over year to $3.4 million from $3.0 million in the prior year. The London-based firm said its revenues for the fiscal year ended June 30 were comprised of $3.1 million from testing services and $300,000 from pharmaceutical services. Renalytix had gained in June US Food and Drug Administration marketing clearance for its blood-based KidneyIntelX.dkd test, which is used to assess progressive kidney function decline in adults with diabetes and early-stage kidney disease. The firm also reported it has to date executed more than 40 commercial payor contracts and become enrolled as a provider in 35 state Medicaid programs. Renalytix reported a net loss of $46.2 million for the year, or $.56 diluted loss per share, compared to a net loss of $49.6 million in fiscal 2022, or $.82 diluted loss per share. The firm ended the year with $24.7 million in cash and cash equivalents.

The company also filed a shelf registration this week with the US Securities and Exchange Commission to sell up to $200 million in mixed securities. Under this registration the company may offer, from time to time, ordinary shares, American depository shares representing ordinary shares, or various series of debt securities or warrants to purchase such securities at prices and on terms to be determined by market conditions at the time of the offering.

Novacyt this week reported an 80 percent drop in year-over-year revenues for the first half of 2023. Revenues in H1 fell to £3.3 million ($4.0 million) from £16.5 million a year ago due to reduced demand for COVID-19 testing. The clinical diagnostics company's net loss for the period amounted to £8.3 million, or £.12 per share, compared to a net loss of £8.7 million, or £.12 per share, in H1 of 2022. As of June 23, Novacyt had £81.7 million in cash and cash equivalents. Earlier this month, the firm completed its acquisition of Yourgene Health for £16.7 million. 

ClearNote Health said this week that its Avantect Pancreatic Cancer test has received a new Current Procedural Terminology Proprietary Laboratory Analyses code from the American Medical Association. The Centers for Medicare and Medicaid Services also released preliminary reimbursement rate determinations for new and revised CPT codes, including code 0410U for Avantect, ClearNote said in a statement. The recommended reimbursement rate for the test is $1,160, and CMS is expected to issue its final determination on the reimbursement rate later this year. The code goes into effect on Oct. 1, and final rates will go into effect on Jan. 1. ClearNote’s test is intended for patients at high risk for pancreatic cancer and uses epigenomic methods to measure levels of 5-hydroxymethylcytosine in cell-free DNA to detect pancreatic cancer signals at an early stage. 

Singulab this week announced a deal for COC Phlebotomy and Lab Services to provide Singulab clients with onsite laboratory collections, logistics, and mobile imaging. The deal, Singulab said will offer its clients a single source for all clinical lab diagnostics. Based in Houston, Singlulab provides precision medicine solutions nationwide. Terms of the deal were not disclosed.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.