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The final NKF-ASN Task Force report recommends:

• The use of the CKD-EPI 2021 eGFR creatinine equation for calculating eGFRcr in adults.^2,3 This new equation is recommended because a race coefficient is not included in its computation and reporting. The CKD-EPI 2021 eGFR creatinine equation included diversity in its development and does not disproportionately affect any one group.³
• National efforts are also underway to facilitate increased, routine, and timely use of cystatin C (CPT 82610), especially to further evaluate eGFRcr in adults who are at risk for or have chronic kidney disease, or in individuals with abnormally high or low muscle mass. The CKD-EPI 2021 eGFR using creatinine and cystatin C (eGFRcr-cys) is more accurate, more closely approximates measured GFR, and supports better clinical decisions than either marker alone.^2,3

The nation’s laboratories are working to employ a consistent, standardized approach for estimating GFR to improve testing for kidney diseases. Together the laboratory organizations (named above) endorse the national implementation of the CKD-EPI 2021 creatinine and creatinine-cystatin C equations for the estimation of glomerular filtration rate.

1. Choosing Wisely, an initiative of the ABIM Foundation. American Society of Clinical Pathology. Recommendation for Chronic Kidney Disease Testing. 2018 (bit.ly/2SFSz3u).
2. Delgado C, Baweja M, Crews DC, et al. A unifying approach for GFR estimation: recommendations of the NKF-ASN Task Force on reassessing the inclusion of race in diagnosing kidney disease. Am J Kidney Dis. doi:10.1053/j.ajkd.2021.08.003.
3. Inker LA, Eneanya ND, Coresh J, et al. New creatinine- and cystatin C–based equations to estimate GFR without race. N Engl J Med. 2021. doi:10.1056/NEJMoa2102953.

Leica, Leap Therapeutics partner on CDx

Leica Biosystems has entered into an agreement with Leap Therapeutics to develop a companion diagnostic to detect Dickkopf-related protein 1 (DKK1). The assay will be used to support clinical development of Leap’s anti-DKK1 cancer therapy, DKN-01, which is being studied now in clinical trials.

Overexpression of DKK1 is associated with poor survival in cancer patients. Leap is studying the DKN-01 drug as part of a combination therapy regimen in a phase two clinical trial in patients with gastric or gastroesophageal junction cancer.

The assay Leica will develop will use RNAscope technology from Bio-Techne on the Bond-III automated staining system, which allows for detection of DKK1 with high sensitivity and specificity, Leica says, to help identify patients most likely to benefit from DKN-01 treatment.

Sema4 to acquire GeneDx

Sema4, an AI-driven genomic and clinical data intelligence platform company, and Opko Health signed a definitive agreement for Sema4 to acquire Opko’s wholly owned subsidiary GeneDx.

Sema4 will acquire GeneDx for $150 million in cash and 80 million shares of Sema4 (the deal includes an additional $150 million in revenue-based milestones over the next two years). The deal is expected to close in the second quarter.